Protein Recommendation to Increase Muscle

NCT02788955 | Completed

• 1 other identifier: HREBA.CC-15-0193
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

Protein; Diet intervention; Muscle; Colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in physical function

  Baseline, week 12

Study Arms (2)

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.

Behavioral: Dietary counselling; Other: Dietary Protein

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.

Behavioral: Dietary counselling; Other: Dietary Protein

Interventions

Dietary counselling BEHAVIORAL

High Protein Diet; Normal Protein Diet

Dietary Protein OTHER

High Protein Diet; Normal Protein Diet

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory adults 18 - 85 years of age;
• Able to communicate in English;
• Recent diagnosis of colorectal cancer (stage II, III or IV);
• Able to complete all baseline assessments within 2 weeks of commencement of chemotherapy or chemoradiotherapy (when applicable);
• ≥1 year life expectancy and believed to be able to complete 12 weeks of intervention (based on clinical judgment);
• Able to provide a blood sample;
• Adequate hepatic function, as confirmed by medical records and to be checked with patient's oncologist;
• Adequate renal function, as confirmed by medical records and to be checked with patient's oncologist;
• If a woman of childbearing potential, she must agree to use an effective form of contraception during the study (are considered effective forms of contraception: abstinence, a hormonal contraceptive, or a double-barrier method).

You may not qualify if:

• Acute inflammation assessed by neutrophil/leukocyte ratio or in consultation with oncologist;
• Ongoing (non-treatment related) nutritional impact symptoms that would impact ability to follow dietary recommendations (ie. anorexia);
• Severe food restrictions (severe food allergy or dietary pattern - e.g. vegetarian);
• Current medical condition that impacts the patients ability to take part in study or impacts the ability to increase muscle (e.g. cachexia, post-surgical wound infection, muscular dystrophy or any degenerative muscle disease or condition);
• Individuals with pacemakers;
• Comorbidities: active treatment for another cancer site, major chronic conditions that would interfere with dietary restriction such as recent myocardial infarction, unstable angina, stroke, or unstable disease such as congestive heart failure;
• Women who are pregnant or breast-feeding;
• Body weight \> 450 lb due to limit of body composition measurement instrumentation;
• Presenting with any health condition that would severely affect nutrient absorption (e.g.: enteric fistula);
• Patients diagnosed with metabolic disorders in consultation with the oncologist (e.g. uncontrolled diabetes, recent diagnosis (\< 3 months) thyroid disease);
• Cognitive impairment or dementia.

Sponsors & Collaborators

• University of Alberta: lead
• Canada Foundation for Innovation: collaborator
• Government of Alberta: collaborator
• Nestlé Health Science Spain: collaborator
• Olymel: collaborator
• Cargill: collaborator

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, Canada

Location

Related Publications (8)

• 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.

  PMID: 18539529 BACKGROUND

• 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.

  PMID: 23750978 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.

  PMID: 23217447 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.

  PMID: 26743210 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.

  PMID: 34891022 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.

  PMID: 33487262 BACKGROUND

• 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.

  PMID: 38849604 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.

  PMID: 37290740 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Dietary Proteins

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Carla Prado

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: June 2, 2016
• Study Start: April 1, 2016
• Primary Completion: April 21, 2022
• Study Completion: April 21, 2022
• Last Updated: April 6, 2023

Record last verified: 2022-10

Locations

CA (2)