• Website: https://primestudy.ualberta.ca/

• Clinical trials.gov number and link or Prospero: NCT02788955 https://clinicaltrials.gov/ct2/show/NCT02788955

• Investigators

• Principal Investigator:

Carla Prado, PhD

• Co-investigators/Study Team:

Katherine Ford

Dr. Helen Vallianatos

Dr. Michael Sawyer

Dr. Sunita Ghosh

Dr. Wendy Wismer

Dr. Mario Siervo

Dr. Nicolaas Deutz

• Funding source(s) and scholarships

Campus Alberta Innovates Program (CAIP)

Olymel®, in kind donation

Cargill®, in kind donation

Nestlé Health Science, in kind donation

• ABSTRACT

Brief introduction, rationale and objective

Severe muscle mass (MM) loss is a defining feature of cancer observed across all types and stages of disease and is an independent predictor of poor clinical outcomes including higher incidences of chemotherapy toxicity and decreased survival. Protein is essential to build MM, yet the optimal amount for preventing or treating muscle loss in patients with cancer remains undefined.

Brief overview methodology

The Protein Recommendation to Increase Muscle (PRIMe) study is a single-center, two-armed, parallel, randomized, controlled pilot trial that assesses the feasibility of utilizing a high protein (HP) diet to positively impact clinical outcomes in people undergoing chemotherapy to treat colorectal cancer. Forty patients with newly diagnosed stage II-IV colorectal cancer who are scheduled to receive chemotherapy will be included. Participants are randomly assigned to a HP or normal protein (NP) diet for twelve weeks. The HP and NP groups receive nutrition recommendations to achieve 2.0 g of protein per kilogram of body weight per day (g/kg/d) and 1.0 g/kg/d, respectively. These values refer to the upper and lower recommended range of protein intake for people with cancer. Energy recommendations are based on measured energy expenditure. Assessments are completed within two weeks of starting chemotherapy (baseline), at week 6, and at week 12. Changes to skeletal MM, physical function, anthropometrics, body composition, muscle strength, physical activity, energy metabolism, metabolic markers, nutritional status, quality of life, readiness to change and psychosocial determinants of behavioural change are assessed between groups. Feasibility of the nutritional intervention is assessed by change in MM as a surrogate marker.

Relevance

This evidence-based study investigates the feasibility of increasing protein intake following a diagnosis of cancer on clinical outcomes during treatment for colorectal cancer. This study will inform larger trials assessing the impact of increasing protein intake in cancer to determine their importance and integration into standard clinical care for people with cancer.

Related publications and review articles

Ford KL, Sawyer MB, Trottier CF, Ghosh S, Deutz NEP, Siervo M, Porter Starr KN, Bales CW, Disi IR, Prado CM. Protein Recommendation to Increase Muscle (PRIMe): Study protocol for a randomized controlled pilot trial investigating the feasibility of a high protein diet to halt loss of muscle mass in patients with colorectal cancer. Clin Nutr ESPEN. 2021 Feb;41:175-185. doi: 10.1016/j.clnesp.2020.11.016. Epub 2020 Dec 24. PMID: 33487262.

Ford KL, Trottier CF, Wismer WV, Sawyer MB, Siervo M, Deutz NEP, Prado CM, Vallianatos H. Drivers of Dietary Choice After a Diagnosis of Colorectal Cancer: A Qualitative Study. J Acad Nutr Diet. 2022 Aug 21:S2212-2672(22)00934-0. doi: 10.1016/j.jand.2022.08.128. Epub ahead of print. PMID: 36002111.

• Clinical trials.gov number and link or Prospero: NCT03795493 https://clinicaltrials.gov/ct2/show/NCT03795493

• Principal Investigators:

Dr. Carla Prado

Dr. Richard Thompson

Dr. Amy Kirkham

• Co-investigators

Dr. Edith Pituskin

Dr. John Mackey

Dr. Karen King

Dr. Ian Paterson

Dr. Kerry Courneya

• Funding source(s) and scholarships

Canadian Institutes of Health Research (CIHR)

Canadian Cancer Society Research Institute (CCSRI)

• ABSTRACT

Brief introduction, rationale and objective

Background & Rationale: Despite major advances in treatment for early stage breast cancer in recent decades leading to an 89% 5-year survival rate, metastatic breast cancer is still considered incurable due to resistance to most available treatments. As such, 5-year survival rate for metastatic breast cancer is only 22%. One mechanism for resistance to cancer therapies and promotion of metastasis in solid tumors is that their vascular system is impaired causing diminished delivery of blood flow, systemic therapy and oxygen. Furthermore, toxicity can be quite high with metastatic regimens, which can limit the dose received. Both diet and exercise have been used to attenuate treatment toxicity, but the promising preclinical evidence showing their potential to enhance chemotherapy efficacy and survival has not been studied in humans. For example, a short bout of aerobic exercise substantially increased tumor blood flow and oxygen delivery, suggesting that exercise during chemotherapy could increase drug delivery to the tumor. Short periods of fasting or caloric restriction also appear to be safe and effective strategies to inhibit tumor growth, enhance chemotherapy efficacy, while also promoting resistance to chemotherapy in healthy cells. Furthermore, combining aerobic exercise and caloric restriction can elicit synergistic effects on outcomes relevant to cancer, including body composition, aerobic fitness, fasting insulin and glucose, insulin-like growth factor, and tumor promoter pathways.

Objectives & Hypotheses: The study objectives are to assess the efficacy of combining acute aerobic exercise and a low-carbohydrate, low-calorie diet administered acutely prior to chemotherapy treatments on CT scan-derived tumor size (primary outcome), magnetic resonance imaging (MRI) markers of tumor response (secondary outcomes), MRI-derived and patient-reported treatment toxicity and quality of life (tertiary outcomes) and progression-free and overall survival (exploratory outcomes).

Brief overview methodology

Methods: Phase II, two-arm, parallel group, randomized, controlled trial. Fifty patients will be randomly assigned to a short-term intervention consisting of both aerobic exercise and caloric restriction administered prior to each of six chemotherapy treatments, or to usual care. Both groups will receive a phone counselling session with a registered dietitian and exercise physiologist.

Participants will include adult women with metastatic breast cancer with measurable pulmonary, visceral, liver, or distant lymphatic metastases that will receive intravenous chemotherapy. The diet intervention consists of provision of meals freshly prepared in a metabolic kitchen under the supervision of a dietitian with reduced caloric content very low carbohydrate content to induce ketosis prior to each chemotherapy. This acute intervention does not lead to long-term nutritional imbalances or weight loss. The aerobic exercise intervention consists of supervised recumbent cycling performed during each chemotherapy. An exercise professional will supervise the session. Exercise intensity and meals will be individualized to participant abilities and preferences. Study assessments will be performed before and after up to six chemotherapy treatments of a consistent treatment protocol. Clinical CT and research questionnaires will also be performed after 3 treatments. Progression-free and overall survival will be tracked for two years after diagnosis.

Related publications and review articles (if any)

Kirkham AA, King K, Joy AA, Pelletier AB, Mackey JR, Zhu X, Meza-Junco J, Young K, Basi S, Price-Hiller J, Brkin T, Michalowski B, Pituskin E, Paterson DI, Courneya KS, Thompson RB, Prado CM. Rationale and design of the Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer(DREAM) Study: A 2-arm parallel-group phase II randomized control trial of a short-term, calorie-restricted, and ketogenic diet plus exercise during intravenous chemotherapy versus usual care. BMC Cancer. 2021;21(1):1093.

• Clinical trials.gov number and link or Prospero: NCT04144907 https://clinicaltrials.gov/ct2/show/NCT04144907

• Principal investigators:

Dr. Carla Prado

Dr. Rajavel Elango

• Co-investigators/Study team:

Dr. Sunita Ghosh

Dr. Leah Gramlich

Dr. Michael Sawyer

Dr. Anna Pujadas Botey

Dr. Anil Abraham Joy

• Funding source(s) and scholarships

Canadian Institutes of Health Research

In kind donation: PFD1 from Mead Johnson

• ABSTRACT

Brief introduction, rationale and objective

Severe muscle loss in patients with cancer has been associated with increased physical disability, extended hospitalization, infectious and noninfectious complications, increased risk of severe toxicity during cancer treatment, poor quality of life and shortened survival. Adequate protein is key to sustain muscle mass and overall health. However, current nutritional recommendations are not specific or evidence-based. The aim of this project is to determine the protein needs of patients with colorectal or breast cancer. Protein needs will be determined using a novel, non-invasive approach. Our results will inform nutritional recommendations and guidelines with the ultimate goal of improving outcomes for people with cancer.

Brief overview methodology

Individuals with newly diagnosed with stage II or III colorectal or breast cancer who will receive first-line treatment (chemotherapy or surgery) will be invited in this metabolic clinical trial. Oxidation of an indicator amino acid will be measured over a range of protein intakes will be used to determine protein requirements in patients with cancer. Breath, urine and blood samples will be collected throughout an 8.5 hour study test day to measure protein metabolism by a stable amino acid isotope. Participants will be invited to complete two test days near their cancer treatment start and two test days near the end of their cancer treatment.

Relevance (if not clear in the intro)

This will be the first study to ever use the indicator amino acid oxidation technique in patients with cancer.

• Principal investigators:

Dr. Carla Prado

• Co-investigators/Study team:

Dr. Bruna Ramos da Silva

Dr. Normand Boulé

Dr. Anil Abraham Joy

• Funding source(s) and scholarships

Cancer Research Institute of Northern Alberta (CRINA)

• ABSTRACT

Brief introduction, rationale and objective

Our study will be the first to measure 24-h energy expenditure (TEE) and its components (resting, activity and food digestion) in patients with breast cancer.

Studies in breast cancer to date (N=8) have only measured energy needs at rest (~30 min tests) and used that to estimate TEE. Therefore, TEE has never been measured. Our study will give us unprecedented information on TEE, as well as its components. It is possible that cancer impacts TEE but also its individual components. In fact, variation in these components has never been explored in any cancer type.

Brief overview methodology

This will be a cross-sectional study with a convenience sample of N=20 women. Patients with newly-diagnosed stages II-III breast cancer will be recruited at the Cross Cancer Institute prior to or < 2 weeks of starting chemotherapy. A whole body metabolic chamber will be used to assess total energy metabolism and several of its components during a 32-hours stay. TEE will be compared to current oncology and commonly used prediction equations. Body composition we will be measured by dual-energy X-ray absorptiometry.

• Clinical trials.gov number and link OR Prospero: https://clinicaltrials.gov/ct2/show/NCT03131921

ClinicalTrials.gov Identifier: NCT03131921

• Principle Investigator:

Carla Prado

• Co-investigators/Study team:

Dr. Michael Sawyer

Sarah Purcell

Joao F Mota

Claire Trottier

• Funding Source (s)- includes scholarships

Canadian Institutes of Health Research New Investigator Salary Award

Canadian Foundation for Innovation John R Evans Leaders Fund

Campus Alberta Innovates Program (CAIP)

Alberta Health Services, Cancer SCN/CancerControl Alberta Seed Grant Funding

• Abstract

Brief Introduction (rationale) and Objective

Studies investigating energy requirements in cancer are inconsistent and requirements may be impacted by cancer therapy. Adequate energy intake is essential to sustain body weight and muscle mass during disease trajectory. The aim of this study was to investigate cancer therapy’s impacts on energy expenditure and body composition in colorectal cancer survivors.

Brief overview methodology

This study measured several indices of nutritional status in 20 patients who completed chemotherapy and/or radiation treatment. Resting energy expenditure was measured using a whole-body calorimetry unit and a portable indirect calorimeter. Total energy expenditure was measured using doubly labeled water. Body composition by bioelectrical impedance analysis, dual X-ray absorptiometry and computerized tomography. Body mass, calf circumference, accelerometry, 3-day food records and Patient-Generated Subjective Global Assessment (PGSGA) Short Form were also evaluated.

Relevance

The results from this project will provide a better understanding of energy requirements and nutritional status in individuals after completing cancer treatment.

• Principal Investigator:

Ana Paula Pagano

Dr. Carla Prado (supervisor)

• Co-Investigators/Study team:

Dr. Anil Abraham Joy

Dr. Maria Cristina Gonzalez

Dr. William J. Evans

• Funding source(s) and scholarships

ASPEN Rhoads Research Foundation Grant (American Society for Parenteral and Enteral Nutrition)

Thermo Fisher Scientific Graduate Scholarship in Agriculture, Food, and Nutritional Science

Elizabeth Russell MacEachran Scholarship

Women & Children's Health Research Institute (WCHRI) Graduate Studentship

University of Alberta Doctoral Recruitment Scholarship

• ABSTRACT

Brief introduction, rationale and objective

Background: Women with breast cancer have high prevalence of low muscle mass while mostly having excess body weight. Additional unfavorable body composition changes occur due to treatment. Low muscle mass and gain of fat are often caused by energy or nutrient intake imbalances. Additionally, cancer alters energy requirements due to a variety of factors such as tumor type, and inflammation. These can in turn impact components of energy metabolism, including resting energy expenditure (REE), the largest and most studied portion of it. Understanding energy metabolism is essential to provide adequate energy intake recommendations.

Objectives: 1) Validate a novel, practical, and cost-effective tool to measure energy needs in clinical settings; and 2) explore the usefulness of bedside body composition techniques in identifying low muscle mass.

Brief overview methodology

Methods: Fifty women newly diagnosed with breast cancer (stages I-III) who were receiving first-line therapy at the Cross Cancer Institute (CCI), Edmonton, Alberta, Canada were recruited for this study. Participants were asked to come the Human Nutrition Research Unit (HNRU) at the University of Alberta for the measurements. Resting energy expenditure was measured by a new portable device and the gold-standard whole-body calorimetry unit (WBCU). Body composition was measured by different techniques, including dual energy x-ray absorptiometry.

Relevance (if not clear in the intro)

Our study will improve how current nutritional assessment is done in clinical settings so that targeted nutritional recommendations are provided to patients. Optimal nutrition improves patient outcomes, treatment tolerance, quality of life and survivorship.

Related publications and review articles (if any)

Pagano, AP.; Ford, KL.; Starr, KNP.; Kiss, N.; Steed, H.; Kung, JY.; Elango, R.; Prado, CM. Energy metabolism in gynecological cancers: a scoping review. Int J Environ Res Public Health. 2022;19(11):6419. doi: 10.3390/ijerph19116419

Book chapter:

Camila L. P. Oliveira; Ana P. Pagano; M. Cristina Gonzalez; Carla M. Prado. Estimation of Lean Soft Tissue by Dual-Energy X-Ray Absorptiometry as a surrogate for muscle mass in health, obesity, and sarcopenia. Neuromethods (Accepted).

• Principal Investigators:

Dr. Carla Prado

Dr. Rajavel Elango

• Co-Investigators/Study team:

Ana Paula Pagano

Dr. Sunita Ghosh

Dr. Leah Gramlich

Dr. Michael Sawyer

Dr. Michael Kolinsky

Dr. Helen Steed

Dr. Maria Aderuza Horst

Dr. Peter Walter

Dr. Thomas Preston

• Funding source(s) and scholarships

CIHR Operating Grant

Campus Alberta Innovates Program Chair

Thermo Fisher Scientific Graduate Scholarship in Agriculture, Food, and Nutritional Science

Elizabeth Russell MacEachran Scholarship

Women & Children's Health Research Institute (WCHRI) Graduate Studentship

University of Alberta Doctoral Recruitment Scholarship

• ABSTRACT

Brief introduction, rationale and objective

Background: Ovarian cancer is the gynecological malignancy with the highest rate of malnutrition, a condition associated with muscle loss. In cancer, low muscle mass is associated with poor outcomes, including severe toxicity to cancer treatment and shortened survival. Malnutrition is often caused by inadequate energy (or calorie) intake compared to individual needs. Understanding energy needs (and how it changes during and beyond cancer) is essential to provide adequate energy intake recommendations. This will, in turn, help prevent and reverse malnutrition, improving patients’ outcomes. However, determining energy needs in cancer is challenging because of its variability due to tumor burden, treatment, inflammation, and body composition (including muscle mass). Additionally, techniques to accurately measure energy needs are costly, time-consuming, and not applicable to clinical settings. This research is the first to investigate the impact of ovarian cancer on total energy needs, and the variables that can affect it, such as treatment, food intake, body composition, physical activity, and inflammation. Objectives: 1) Explore energy needs at the time of cancer diagnosis and its changes during cancer treatment and survivorship; 2) determine what variables influence energy needs; and 3) validate a new and simple technique to practically estimate energy needs in clinical settings.

Brief overview methodology

Methods: Thirty-three patients with ovarian cancer (stages II- IV) are having their energy expenditure measured by sophisticated techniques (i.e., doubly labeled water [DLW], and indirect calorimetry) at 3 timepoints, at the Human Nutrition Research Unit (HNRU): 1) close to the time treatment started; 2) close to the end of treatment; 3) up to 8 months after treatment end date. Body composition is being measured using different techniques, including dual energy x-ray absorptiometry. Three-day food records are being collected to assess patient’s food intake and accelerometers are being worn to assess physical activity patterns at the same time of the DLW assessment. Blood draws are being performed to assess inflammation status.

• Related publications and review articles

Pagano, AP.; Ford, KL.; Starr, KNP.; Kiss, N.; Steed, H.; Kung, JY.; Elango, R.; Prado, CM. Energy metabolism in gynecological cancers: a scoping review. Int J Environ Res Public Health. 2022;19(11):6419. doi: 10.3390/ijerph19116419

• Book chapter:

Camila L. P. Oliveira; Ana P. Pagano; M. Cristina Gonzalez; Carla M. Prado. Estimation of Lean Soft Tissue by Dual-Energy X-Ray Absorptiometry as a surrogate for muscle mass in health, obesity, and sarcopenia. Neuromethods (Accepted).

• Investigators

Principal investigators:

Carla Prado

Katherine Ford

Co-investigators/Study Team:

Danilo Pereira

Rachel Murphy

Sven Anders

Wendy Wismer

• Funding Source

CFDR – Canadian Foundation for Dietetic Research

• Abstract

Brief Introduction (rationale) and Objective

Lung, breast, colorectal, and prostate cancers are the four most common cancer types in Canada; they account for approximately 50% of new cases in our country. It is known that proper nutrition during cancer helps people maintain strength and energy and manage side effects of treatment and recovery. Nutrition knowledge is one of the factors that influence peoples’ nutritional choices. Although there are many sources of nutrition information available to the public, not all of these are trustworthy, and use of incorrect resources may lead to poor nutrition choices that have a negative impact on health. This research will answer questions regarding the nutrition knowledge and sources of information used by patients who are diagnosed with cancer, and how these and other patient characteristics impact dietary choices and diet quality. Researchers at the Universities of Alberta and British Columbia will recruit individuals who have lung, breast, colorectal, or prostate cancer to complete a survey that is designed to assess nutrition knowledge, where individuals collect nutrition information, and how these factors, among others, are related to dietary decisions following a cancer diagnosis. This information will help registered dietitians provide better nutritional counselling to individuals with cancer and create resources that include nutritional advice and recommendations on trustworthy sources of information.

• Clinical trials.gov number and link OR Prospero: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=253111

• Principal Investigator:

Dr. Carla Prado

• Co-Investigators/Study team:

Ana Paula Pagano

Camila E. Orsso

Dr. Juliana Sicchieri

Janice Kung

Dr. Claude Pichard

Dr. Pierre Singer

• Funding Sources

CIHR Operating Grant

Campus Alberta Innovates Program Chair

ASPEN Rhoads Research Foundation Grant (American Society for Parenteral and Enteral Nutrition)

Thermo Fisher Scientific Graduate Scholarship in Agriculture, Food, and Nutritional Science

Elizabeth Russell MacEachran Scholarship

Women & Children's Health Research Institute (WCHRI) Graduate Studentship

University of Alberta Doctoral Recruitment Scholarship

• Abstract

Background: Understanding energy requirements is essential to support and/or modulate energy balance, which may ultimately help optimize weight and body composition (i.e., the amount of muscle and fat masses). In cancer, this is particularly relevant, once body composition impacts patients’ clinical outcomes (e.g., toxicity to treatment, quality of life, and survival). Evidence in the literature regarding resting energy expenditure (REE) — the largest and most commonly studied component of total energy expenditure — in cancer is still unclear and controversial. As such, current oncology nutrition guidelines are nonspecific for this cohort and do not differ from that recommended to the general healthy population. Accurate REE estimations is essential to promote targeted energy recommendations that can help prevent the loss of muscle mass associated with cancer, and/or the gain of excessive weight (fat mass), and in turn improve clinical outcomes.

Objectives: To investigate whether REE of patients diagnosed with cancer differs from healthy individuals. To explore whether body composition explained differences in REE, in case differences exist.

Brief overview methodology

Methods: A systematic review was performed in MEDLINE, EMBASE, CINAHL, SPORTDiscus, and Scopus databases. Additional search included reference lists of eligible studies and review articles as well as grey literature sources such as Google, ProQuest Dissertations & Theses Global. Adults with all types and stages of cancer (age ≥18 years); undergoing any type and phase of cancer treatment; and any forms of feeding are being considered. Observational studies (i.e., cross-sectional, longitudinal, cohorts, case-control) are additionally being included. Previous published reviews and/or meta-analysis, randomized clinical trials, and case-report are being excluded. To assess the quality of studies, the National Heart, Lung, and Blood Institute Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies are being used. Two reviewers are assessing the quality of studies independently, with disagreements being resolved by consensus.

• Clinical trials.gov number and link or Prospero: Pro00121051

• Principal investigator:

Dr. Carla Prado

• Co-investigators/Study team

Camila Orsso

Claire Trottier

Dr. Martin Ferguson-Pel

Dr. Steven Johnson

Dr. Douglas Klein

Dr. Amy Kirkham

Dr. Sarah Neil-Sztramko

Dr. Bukola Oladunni Salami

Dr. Nathanial Maeda (additional author)

• Funding source(s) and scholarships

Alberta Health

• ABSTRACT

Brief introduction, rationale and objective

Excess body weight, poor diet, physical inactivity, alcohol consumption, stress, and sleep deprivation/disruption are modifiable risk factors associated with chronic diseases, such as cancer. While most Canadians may be aware that these play a role in chronic disease prevention, individualized tools are needed to foster sustainable, long-term habits.

Digital health solutions have become commonplace in self-care. They offer an opportunity to reach a large number of individuals with personalized programs to improve health and lower the risk of developing chronic disease. Many digital applications are available for individuals to monitor their diet, activity and weight; however, few have been validated and are based on scientific evidence.

Recently, a Canadian web-based platform centered on preventive self-care became available. This platform was created by health care professionals and encompasses three key pillars of health: nutrition, physical activity, and mindfulness. The effectiveness of this web-based wellness platform will be evaluated in people living with excess body weight to improve six chronic disease risk factors: body weight, diet quality, physical activity, alcohol intake, stress, and sleep habits. A fully self-guided approach (active control, Arm 1) will be compared to an approach guided by a healthcare professional (Arm 2) and compare risk factors pre- and post-intervention. Investigators hypothesize is that both approaches will improve modifiable risk factors, but participants guided by a healthcare professional will have greater improvements. Qualitatively, the experiences of immigrants using the platform will be explored.

Brief overview methodology

Participants will use the web-based platform for 16 weeks. Our primary outcome is 5% weight loss, which has been shown to reduce chronic disease incidence. Secondary outcomes include improvements in overall diet quality, physical activity and sleep quality, and decrease in alcohol intake and stress. To assess the primary and one of the secondary outcomes (physical activity), a smart scale and a wearable device will be used. Wearable devices are widely used and an effective approach to body weight reduction. Additionally, immigrants' experiences and perspectives of participating in this study will be explored using semi-structured interviews.

• Clinical trials.gov number and link OR Prospero: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=67467

• Principal Investigator:

Dr. Carla Prado

• Co-Investigators/Study Team

Ana Paula Pagano

Dr. Bruna Silva

Dr. Sarah Purcell

Dr. Flavio Vieira

Fernando Meira

Dr. Flavia Silva

Dr. Michelle Mackenzie

Dr. Jennifer Vena

Dr. Paula Robson

Dr. John Lewis

• Funding Sources

Prostate Cancer Canada Targeted RFP in Prostate Cancer Prevention Thermo Fisher Scientific Graduate Scholarship in Agriculture, Food, and Nutritional Science

Elizabeth Russell MacEachran Scholarship

Women & Children's Health Research Institute (WCHRI) Graduate Studentship

University of Alberta Doctoral Recruitment Scholarship

• Abstract

Background: Metabolic diseases such as type 2 diabetes mellitus (T2DM) may have a role in the development and progression of prostate cancer (PC). While T2DM seems to reduce the secretion of hormones that stimulate cell division in the prostate gland (e.g., testosterone), it may also be associated with higher secretion of growth hormones (e.g., insulin-like-growth-factor-I) that stimulates prostate cell proliferation. However, the association between T2DM and PC development remains to be explored, especially in the context of specific PC stages.

Objectives: To systematically review the evidence for an association between T2DM and overall, early, or advanced PC risk. We will additionally investigate whether time elapsed since T2DM diagnosis play a role in PC development.

Brief overview methodology

Methods: A systematic review was performed in MEDLINE, EMBASE, and CINAHL. Cohort, case-control, and cross-sectional studies that assessed the risk of PC associated with T2DM are being included. The Newcastle-Ottawa Scale (NOS) is being used to assess the quality of studies; those with NOS <7 will be excluded. Two reviewers are assessing the quality of studies independently, with disagreements resolved by consensus.

Relevance (if not clear in the Intro)

Diabetes is a prevalent disease worldwide that may be linked to PC development. Findings from this study can inform public health preventive strategies (including new screening approaches) to reduce the risk of PC development in men with a recent T2DM diagnosis.

• Website: www.pomelo.ualberta.ca

• Clinical trials.gov number and link or Prospero: NCT05026385 https://www.clinicaltrials.gov/ct2/results?cond= term=NCT05026385& cntry=&state=&city=&dist=

• Investigators

Principal investigators:

Carla M. Prado

Mary Forhan

• Co-investigators/Study team

Kristine Godziuk

Flavio Teixeira Vieira

• Funding source(s) and scholarships

Arthritis Society (strategic operating grant)

KG is supported by an Alberta Innovates Fellowship in Health Innovation.

• ABSTRACT

Brief introduction, rationale and objective

Individuals with advanced knee osteoarthritis (OA) and a body mass index (BMI) ≥35kg/m 2 have a higher risk of complications with total knee arthroplasty (TKA), and hence may be ineligible for surgery unless they reduce their BMI. However, pre-TKA weight-loss has not been shown to reduce surgical infection risk and may inadvertently increase risk for muscle loss and development of sarcopenic obesity. This study examines if a weight-neutral behavioural intervention is feasible and acceptable to participants, and improves muscle mass and physical function in comparison to usual care.

Brief overview methodology

This pilot randomized clinical trial compares a 12-week multimodal intervention [including targeted nutrition, progressive resistance exercise, and arthritis self-management support] to usual care. Co-primary outcomes are feasibility and acceptability, with secondary outcomes of change in lean soft tissue and physical function within and between groups at 3-months and 9-months from baseline.

Relevance

This study will inform future development of more personalized knee OA treatment approaches for adults with larger bodies. Further, it will inform strategies and approaches for sarcopenic obesity identification, prevention, and treatment in OA.

Protocol paper:

Godziuk K, Prado CM, Forhan M. (2022) Protocol for the POMELO (Prevention Of MusclE Loss in Osteoarthritis) pilot feasibility trial. Osteoarthritis and Cartilage Open.

https://doi.org/10.1016/j.ocarto.2022.100312

Development paper:

Godziuk K, Prado CM, Forhan M. (2022) Patient engagement in the design of an intervention to prevent muscle loss in individuals with knee osteoarthritis and a BMI ≥35. Musculoskeletal Care, 20(3): 557-569.

https://pubmed-ncbi-nlm-nih-gov.login.ezproxy.library.ualberta.ca/34928546/

• Principal investigators:

Mary Forhan

Carla M. Prado

• Co-investigators/Study team

Kristine Godziuk

• Funding sources

Alberta Health Services Seed Grant (from the Bone and Joint Health Strategic Clinical Network)

In-kind support from Revive Wellness

KG is supported by an Alberta Innovates Fellowship in Health Innovation.

• ABSTRACT

Brief introduction, rationale and objective

Access to behavioural supports for nutrition, exercise, and mindfulness in patients who have osteoarthritis (OA) could be improved through the use of digital health interventions. These behavioural supports can assist with long-term management of OA symptoms, which could improve patient outcomes and potentially reduce or delay the need for more intensive and costly OA interventions, such as knee replacement. This study evaluated the effectiveness and acceptability of a 12-week multimodal digital intervention (comprised of nutrition, exercise, and mindfulness support) in adults with knee OA.

Brief overview methodology

Adults with advanced knee OA and an orthopaedic referral were invited to self-enroll in this non-randomized intervention. OA-focused resources were delivered weekly by email, and additional digital components could be accessed on-demand (e.g. web-platform, webinars). Effectiveness of the digital intervention was assessed by change in patient-reported health outcomes between baseline and 12-weeks. Acceptability was assessed by study completion rates and qualitative interview data.

Related publications and review articles

Godziuk K, Prado CM, Quintanilha M, Forhan M. Effectiveness and acceptability of a 12-week digital behavioural health intervention in patients with knee osteoarthritis. (currently under review)

• Website: https://premium.ualberta.ca/

• Clinical trials.gov number and link or Prospero: NCT03235804 https://clinicaltrials.gov/ct2/show/NCT03235804?term=NCT03235804&draw=2&rank=1

• Principal Investigators:

Dr. Carla Prado

Dr. Jens Walter

• Co-investigators/Study Team

Julia Montenegro

Dr. Arya Sharma

Dr. Camila Oliveira

Dr. Aloys Berg

Dr. Laurie Mereu

Dr. Sunita Ghosh

Dr. Cristiane Cominetti

• Funding source(s) and scholarships

This study is sponsored by Almased Wellness GmbH.

Julia Montenegro received the following scholarships: the University of Alberta Doctoral Recruitment Scholarship (2021), the Alberta Diabetes Institute (ADI) Graduate Studentship Award (2021), the Guelph Food Technology Centre (GFTC) Legacy Fund Scholarship (2021), and the Alberta Graduate Excellence Scholarship (2022).

• ABSTRACT

Brief introduction, rationale and objective

Excess body weight is associated with a state of low-grade chronic inflammation and detrimental changes in the gut microbiome. Powdered meal replacements (PMR) have been shown to be an effective strategy for weight management; however, their effect on inflammation and the gut microbiome remains unclear. The aim of this 12-week randomized control clinical trial is to investigate the effects of PMR consumption on inflammation, gut microbiome, and overall metabolism in individuals with excessive body weight.

Brief overview methodology

Healthy adults with overweight and obesity (n=88) will be recruited and randomly assigned to one of the following groups: a) Control group (CON): maintain usual diet, or b) PMR group: replace morning and afternoon snacks daily with a PMR. Participants are assessed at baseline, week 6, and week 12. Fasting blood samples are collected to analyze systemic inflammation, metabolic biomarkers, and gene expression. Stool samples are collected to analyze gut microbiota diversity and composition. Body composition, resting energy expenditure, dietary intake, and appetite sensation are also assessed. Participants are asked to maintain a stable body weight and physical activity level throughout the study and fill out a journal with information about PMR consumption, body weight, food intake, appetite sensations, and medications.

Relevance

This will study has a systematic and comprehensive approach of the effects of the PMR on inflammation, gut microbiome, and metabolism on people with overweight or obesity with a stable weight. The results gathered from this study can be used to develop strategies to optimize diet quality and health of people with overweight and obesity, preventing the development of comorbidities.

• Principal investigators:

Stuart Phillips

Carla Prado

Marla Beauchamp

Sharon Kirkpatrick

Alexandra Mayhew

James McKendry

Jacqueline McMillan

Paul McNicholas

Parminder Raina

• Funding Source

Canadian Institutes for Health Research

• Abstract

Brief Introduction (rationale) and Objective

The concept of declining function with age requires a better understanding of whether it is an immutable characteristic of aging or whether it can be mitigated. When we age, we lose muscle. However, we are uncertain whether declines in muscle mass directly contribute to declining physical mobility with age. This loss of muscle is referred to as sarcopenia, a term that was simply a loss of muscle when it was originally coined. More recent redefinitions of sarcopenia have framed it as the loss of muscle mass AND physical function (strength and walking speed, for example). Importantly, sarcopenia in older persons is associated with increased adverse outcomes, including falls, functional decline, frailty, and mortality. Sarcopenia has recently received recognition as a treatable condition with the receipt of a code for billing by physicians in certain jurisdictions. Despite being able to bill for diagnosing and treating sarcopenia, it can be defined as a treatable condition in several ways. Thus, its diagnosis is decidedly complex. Importantly, our team showed that various ways of diagnosing sarcopenia result in various people having sarcopenia and others not, whereas another definition reverses the previous diagnosis. With confusion around how to diagnose sarcopenia, its use in clinical situations becomes tenuous at best. Our main assertion is that the biological substrate of sarcopenia, skeletal muscle, has not been accurately measured. This lack of accurate measurement has led to confusion about whether measuring muscle is clinically relevant in sarcopenia. Our main idea is that skeletal muscle mass, when accurately measured, is a powerful predictor of functional declines in older men and women. We will use a novel method to measure skeletal muscle in a large cohort of older men and women and track them for two years. We plan to show that our method of measuring muscle will show a strong association between change in muscle mass and decline in mobility.

• Clinical trials.gov number and link or Prospero: NCT05422924 https://clinicaltrials.gov/ct2/show/NCT05422924

• Principal Investigator:

Dr. Carla Prado

• Co-investigator/Study team:

Montserrat Montes-Ibarra

Dr. Richard Thompson

Dr. Edith Pituskin

Dr. Catherine Chan

Dr. Ian Paterson

• ABSTRACT

Patients with COVID-19 may experience prolonged physical and psychological symptoms after weeks or months of the infection. This may be caused by a combination of factors including poor nutrition, low physical activity, and lack of emotional support. Leading to poor overall health and low quality of life.

Recently, a Canadian web-based platform called My Viva Plan® became available. This program is the first of its kind because it is based on preventive self-care and it includes three key pillars of health: nutrition, fitness, and mindfulness. We propose to use this program to provide guidance related to diet, fitness, and mindfulness in an 8 weeks pilot study of patients with Long COVID.

Our study will randomly place participant students into one of the following two groups; one group will be the intervention arm (participants who will use the platform) vs. another group who will be the control (participants who will not use the platform). Each participant's demographic and body composition characteristics will be collected at the start of the study (week 1) and at the end of it (week 8). At the end of the study all data collected will be compared between both visits.

Our objective is to determine if the use of an online application that is based on preventive self-care and that includes three key pillars of health: nutrition, fitness, and mindfulness, will result in a better quality of life, improvement of symptoms, and reduced stress in patients with long COVID.

Brief introduction, rationale and objective

COVID-19 pandemic has been associated with worsened physical functioning and persistence of muscular related symptoms after months of acquiring SARS-CoV-2. In addition, other psychological symptoms (i.e., anxiety, depression, or sleep disorders) are also being observed more frequently that could lead to overall poor quality of life.

A balanced nutritional intake, physical activity and emotional support can contribute to the improvement of muscle mass and overall health in patients with long COVID. Since the pandemic started, the internet has been a more powerful tool for many individuals looking for healthcare support, such as nutrition education and lifestyle improvement. Many health professionals enhance their practices with web-based nutrition and fitness platforms while saving time and improving communication with their patients.

This project will use My Viva Plan^®, which is the first digital preventative self-care treatment program encompassing three key pillars of health: nutrition, fitness, and mindfulness. As a self-directed program, the goal of the My Viva Plan^® is to “empower users to visualize their world through daily reflections”, which can potentially be translated into increased awareness of personal behaviors and hence improvement of lifestyle.

Brief overview methodology

Potential participants with Long COVID will be screened from the Kaye Edmonton Clinic and will be randomly assigned to either the control group (CON) or the web-based platform group (WBP) where participants will use My Viva Plan. During the two visits, body composition assessments, questionaries, MRI and one-on-one semi-structured interviews will be assessed in both groups.

Relevance

This is the first study to investigate how a digital platform (nutrition, exercise and mindfulness) can help to achieve changes in quality of life and other nutritional and mindfulness outcomes in patients with long COVID.

• Clinical trials.gov number and link or Prospero: CRD42021283031 https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=283031

• Principal investigator:

Carla Prado

• Co-investigators/Study Team:

Montserrat Montes-Ibarra

Camila Orsso

Ana Teresa Limon-Miro

Dr. Cristina Gonzalez

Dr. Emanuele Marzetti

Dr.Francesco Landi

Dr. Steve B Heymsfield

Dr. Rocco Barazonni

• ABSTRACT

The impact of body composition (BC) abnormalities and COVID-19 outcomes remains to be determined. We systematically summarized the evidence on BC abnormalities and their potential relationship with adverse clinical outcomes in COVID-19 patients.

A systematic search was conducted in MEDLINE (Ovid), Embase (Ovid), CINAHL and SCOPUS (last search date: March 3, 2022). We included observational studies that used BC to measure quantity and/or composition of skeletal muscle (or its related compartments), adipose tissue (AT, or its related compartments), phase angle, or sarcopenia, or sarcopenic obesity in adults with COVID-19. Methodological quality of included studies was assessed using the Newcastle-Ottawa Scale. We reported the prevalence range of BC abnormalities and the number of studies describing significant associations between BC and clinical outcomes (with some studies investigating more than one BC compartment).

We included 47 studies (66% low risk of bias), with N=6029 participants plus an additional 435,504 from a single study (N=441,533 total); age ranged from 18 to 86 years. BC was assessed using computed tomography (CT, n=34), bioelectric impedance analysis (BIA, n=10), and ultrasound (n=4); of these, one study used two techniques (CT and BIA). Prevalence ranged from 24-65.4% for low muscle mass, 28.7%-85.2% for low CT muscle radiodensity, 64.5-69.6% for high visceral AT, and was 75% for high subcutaneous AT (single study). Low phase angle was found in 96% among non-survivors (single study). BC abnormalities were associated with mortality in 23/34 studies (67.6%), intensive care unit admission in 20/34 studies (58.8%), mechanical ventilation or disease severity in 25/39 studies (64.1%), and hospitalization rate or length of hospital stay in 16/26 studies (61.5%).

Abnormalities in BC, including low muscle quantity, low muscle radiodensity, low phase angle, and high AT (especially visceral AT), were common in patients with COVID-19 and associated with adverse clinical outcomes.

Brief introduction, rationale and objective

Body composition may also play a role in COVID-19 severity. Evidence suggests that individuals with low muscle mass, low computed tomography (CT) radiodensity (reflective of myosteatosis), and/or excess adiposity may be at higher risk for greater disease severity and death. The aim was to summarize the evidence on the prevalence of body composition abnormalities in COVID-19. We additionally investigated the relationship between body composition phenotypes and adverse outcomes, including mortality, ICU admission, mechanical ventilation (MV), disease severity, hospitalization, length of stay, among others.

Brief overview methodology

A comprehensive search including observational studies that used BC to measure quantity and/or composition of skeletal muscle, adipose tissue, phase angle, or sarcopenia, or sarcopenic obesity in adults with COVID-19 was conducted in MEDLINE (Ovid), Embase (Ovid), CINAHL and SCOPUS (last search date: March 3, 2022. Titles and abstracts were screened for inclusion criteria in duplicate and full text of relevant articles were retrieved and examined by three independent reviewers. Relevant data was extracted and was classified based on measures and techniques used for assessment. The association between body composition and outcomes and/or differences in body composition or outcomes between analyzed groups were reported.

Methodological quality of included studies was assessed independently by two reviewers using the Newcastle-Ottawa Scale (NOS)

• Principal investigator:

Carla Prado

• Co-investigators/Study Team:

Montserrat Montes-Ibarra

Camila Oliveira

Dr. Richard Thompson

Dr. Ian Paterson

• ABSTRACT

Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Like other respiratory diseases, patients infected with COVID-19 usually present with common cold manifestations, bronchiolitis, and pneumonia. However, 15 to 31% of infected individuals develops an acute respiratory distress syndrome, compromising several organs and systems (especially heart, lungs, brain, and liver), which may lead to multi-organ failure and death. In addition, critically ill patients with COVID-19 are usually in a hypermetabolic state, presenting with a measured resting energy expenditure (REE) 299% of predicted. Fat-free mass has been reported to account for most of the variability in REE, with organs accounting for 70 to 75% of this energy metabolism component. For this reason, organ mass has been used to model and predict REE.

Considering the hypermetabolic state and concurrent multi-organ involvement usually observed in critically ill patients infected with COVID-19, the aim of this study was to assess the contribution of masses of the heart, lungs, brain, kidney, and liver to REE in recovered COVID-19 patients. This study is a prospective, cohort study involving additional analyses of the MOIST Study: Multi-Organ Imaging with Serial Testing in COVID-19 Infected Patients (Pro00102389), body composition and REE assessments.

Brief introduction, rationale and objective

Considering the hypermetabolic state and concurrent multi-organ involvement usually observed in critically ill patients infected with COVID-19, it is of extreme importance the assessment of the individual contribution of each organ to REE in recovered COVID-19 patients, since organs account for most of this energy metabolism component.

The objective of this study was to assess the contribution of masses of the heart, lungs, brain, kidney, and liver to REE in recovered COVID-19 patients and demonstrate if a hypermetabolic state is be positively correlated with elevations in masses and energy expenditure of the heart, lungs, brain, and liver. Outcomes measured were: energy expenditure of the liver, heart, lungs, kidney, brain and masses of the same organs. In addition measured and predicted REE.

Brief overview methodology

Participants enrolled in the MOIST Study were invited to attend a study visit at the Human Nutrition Research Unit (University of Alberta) and answer some questions with their personal information (i.e., date of birth and sex), complete a 30-minute REE test, which was followed by anthropometrics assessment, hand grip strength, and body composition assessment.

Relevance

This study will be the first to use advanced imaging techniques to measure organ mass model and predict REE of patients with COVID-19.