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| Name | Class |
|---|---|
| Canada Foundation for Innovation | OTHER |
| Government of Alberta | OTHER_GOV |
| Nestlé Health Science Spain | INDUSTRY |
| Olymel |
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This is a feasibility study to test the potential efficacy of diets of different amounts of protein and calories for patients with cancer. We hypothesize that nutritional deficits play a significant role in muscle loss and that nutritional therapy is an important first step in reversing or preventing muscle loss and maintaining/improving physical function.
Severe muscle depletion (sarcopenia) is a common issue among cancer patients and adequate nutrient intake is pivotal to maintain muscle mass. Yet, optimal amounts of protein are undefined for preventing or treating sarcopenia in people with cancer as most methodological approaches to assess protein requirements are expensive, burdensome and unfeasible for this population. This study's overarching goal is to investigate the potential efficacy of diets of different protein content on: 1) muscle mass maintenance (primary endpoint); and 2) improvements on physical function in cancer patients capable of oral nutrition support. Additional study measurements include: energy metabolism (including total body), body composition using multi-compartment models, blood biomarkers, and quality of life.
In a randomized controlled trial approach, we will employ high protein feeding (2 g/kg/d, n=16) versus a standard recommendation (1 g/kg/d, n=16) in patients with newly diagnosed colorectal cancer for 12 weeks. Prescribed energy intakes will be framed by the amount of calories to meet energy needs and to support protein synthesis, but prevent fat mass gain. Carbohydrate, fat and protein intake will be adjusted throughout the intervention to achieve the desired rate and amount of energy and protein intake. An oral protein powder supplement made from high-quality whey protein will be provided to the participants to help increase their protein intake as needed. A multivitamin will be given to all participants throughout the study. Participants will receive weekly calls from the study coordinator to ensure adherence to the dietary intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Protein Diet | Active Comparator | In the normal protein diet, participants will be instructed to follow a diet that will provide them with the amount of calories enough to meet their energy needs without changing their body weight and will contain 1 g of protein per kilogram of body weight. Participants will be instructed to consume protein primarily from animal food sources. A high quality whey protein supplement will be provided as needed. |
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| High Protein Diet | Experimental | In the high protein diet, participants will be instructed to follow a diet that will provide them with the amount of calories enough to meet their energy needs without changing their body weight and will contain 2 g of protein per kilogram of body weight. Participants will be instructed to consume protein primarily from animal food sources. A high quality whey protein supplement will be provided as needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary counselling | Behavioral |
| ||
| Dietary Protein |
| Measure | Description | Time Frame |
|---|---|---|
| Change/maintenance in muscle mass | To assess the change in muscle mass from baseline to week 12 using Dual-energy X-ray absorptiometry (DXA). | Baseline, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical function | To assess the change in total score on the Short Performance Physical Battery (SPPB) test from baseline to week 12. | Baseline, week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carla Prado | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | T6G 2E1 | Canada | ||
| Cross Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18539529 | Background | Prado CM, Lieffers JR, McCargar LJ, Reiman T, Sawyer MB, Martin L, Baracos VE. Prevalence and clinical implications of sarcopenic obesity in patients with solid tumours of the respiratory and gastrointestinal tracts: a population-based study. Lancet Oncol. 2008 Jul;9(7):629-35. doi: 10.1016/S1470-2045(08)70153-0. Epub 2008 Jun 6. | |
| 23750978 |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D004044 | Dietary Proteins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| UNKNOWN |
| Cargill | INDUSTRY |
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| Other |
|
| Edmonton |
| Alberta |
| Canada |
| Prado CM, Lieffers JR, Bowthorpe L, Baracos VE, Mourtzakis M, McCargar LJ. Sarcopenia and physical function in overweight patients with advanced cancer. Can J Diet Pract Res. 2013 Summer;74(2):69-74. doi: 10.3148/74.2.2013.69. |
| 23217447 | Background | Prado CM, Lieffers JR, Bergsten G, Mourtzakis M, Baracos VE, Reiman T, Sawyer MB, McCargar LJ. Dietary patterns of patients with advanced lung or colorectal cancer. Can J Diet Pract Res. 2012 Winter;73(4):e298-303. doi: 10.3148/73.4.2012.e298. |
| 26743210 | Background | Prado CM, Cushen SJ, Orsso CE, Ryan AM. Sarcopenia and cachexia in the era of obesity: clinical and nutritional impact. Proc Nutr Soc. 2016 May;75(2):188-98. doi: 10.1017/S0029665115004279. Epub 2016 Jan 8. |
| 34891022 | Background | Ford KL, Arends J, Atherton PJ, Engelen MPKJ, Goncalves TJM, Laviano A, Lobo DN, Phillips SM, Ravasco P, Deutz NEP, Prado CM. The importance of protein sources to support muscle anabolism in cancer: An expert group opinion. Clin Nutr. 2022 Jan;41(1):192-201. doi: 10.1016/j.clnu.2021.11.032. Epub 2021 Nov 29. |
| 33487262 | Background | 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. |
| 38849604 | Derived | Ford KL, Quintanilha M, Trottier CF, Wismer W, Sawyer MB, Siervo M, Deutz NEP, Vallianatos H, Prado CM. Exploring relationships with food after dietary intervention in patients with colorectal cancer: a qualitative analysis from the Protein Recommendations to Increase Muscle (PRIMe) trial. Support Care Cancer. 2024 Jun 7;32(7):418. doi: 10.1007/s00520-024-08620-1. |
| 37290740 | Derived | Ford KL, Pichard C, Sawyer MB, Trottier CF, Disi IR, Purcell SA, Ghosh S, Siervo M, Deutz NE, Prado CM. Total energy expenditure assessed by 24-h whole-room indirect calorimeter in patients with colorectal cancer: baseline findings from the PRIMe study. Am J Clin Nutr. 2023 Aug;118(2):422-432. doi: 10.1016/j.ajcnut.2023.06.002. Epub 2023 Jun 7. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |