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Protein Recommendation to Increase Muscle (PRIMe)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dietary counselling
Dietary Protein
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Protein, Diet intervention, Muscle, Colorectal cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Alberta
  • Cross Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Normal Protein Diet

High Protein Diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change/maintenance in muscle mass
To assess the change in muscle mass from baseline to week 12 using Dual-energy X-ray absorptiometry (DXA).

Secondary Outcome Measures

Change in physical function
To assess the change in total score on the Short Performance Physical Battery (SPPB) test from baseline to week 12.

Full Information

First Posted
March 23, 2016
Last Updated
April 4, 2023
Sponsor
University of Alberta
Collaborators
Canada Foundation for Innovation, Government of Alberta, Nestlé Health Science Spain, Olymel, Cargill
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1. Study Identification

Unique Protocol Identification Number
NCT02788955
Brief Title
Protein Recommendation to Increase Muscle
Acronym
PRIMe
Official Title
Decreasing the Burden of Sarcopenia in Cancer Through Targeted Nutrition Intervention: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 21, 2022 (Actual)
Study Completion Date
April 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Canada Foundation for Innovation, Government of Alberta, Nestlé Health Science Spain, Olymel, Cargill

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Protein, Diet intervention, Muscle, Colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Protein Diet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High Protein Diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dietary counselling
Intervention Type
Other
Intervention Name(s)
Dietary Protein
Primary Outcome Measure Information:
Title
Change/maintenance in muscle mass
Description
To assess the change in muscle mass from baseline to week 12 using Dual-energy X-ray absorptiometry (DXA).
Time Frame
Baseline, week 12
Secondary Outcome Measure Information:
Title
Change in physical function
Description
To assess the change in total score on the Short Performance Physical Battery (SPPB) test from baseline to week 12.
Time Frame
Baseline, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Prado
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18539529
Citation
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.
Results Reference
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PubMed Identifier
23750978
Citation
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.
Results Reference
background
PubMed Identifier
23217447
Citation
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.
Results Reference
background
PubMed Identifier
26743210
Citation
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.
Results Reference
background
PubMed Identifier
34891022
Citation
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.
Results Reference
background
PubMed Identifier
33487262
Citation
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.
Results Reference
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Protein Recommendation to Increase Muscle

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