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Trial record 1 of 2 for:    26743210 [PUBMED-IDS]
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Protein Recommendation to Increase Muscle (PRIMe)

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ClinicalTrials.gov Identifier: NCT02788955
Recruitment Status : Recruiting
First Posted : June 2, 2016
Last Update Posted : October 28, 2019
Sponsor:
Collaborators:
Canada Foundation for Innovation
Government of Alberta
Nestlé Health Science Spain
Olymel
Cargill
Information provided by (Responsible Party):
Carla Prado, University of Alberta

Brief Summary:
This is a feasibility study to test the 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, tolerance to treatment and quality of life.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Dietary counselling Other: Dietary Protein Not Applicable

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 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, tolerance to treatment, quality of life and overall prognosis.

In a randomized controlled trial approach, we will employ high protein feeding (2 g/kg/d, n=18) versus a standard recommendation (1 g/kg/d, n=18) 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Decreasing the Burden of Sarcopenia in Cancer Through Targeted Nutrition Intervention: A Feasibility Study
Study Start Date : April 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Standard Protein Diet
In the standard 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
Experimental: High Protein Diet
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



Primary Outcome Measures :
  1. Change/maintenance in muscle mass [ Time Frame: Baseline, week 12 ]
    To assess the change in muscle mass from baseline to week 12 using Dual-energy X-ray absorptiometry (DXA).


Secondary Outcome Measures :
  1. Change in physical function [ Time Frame: Baseline, week 12 ]
    To assess the change in total score on the Short Performance Physical Battery (SPPB) test from baseline to week 12.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory adults 18 - 85 years of age;
  • Able to communicate in English;
  • Recent diagnosis (<7 months) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788955


Contacts
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Contact: Claire Trottier 780-492-7820 ctrottie@ualberta.ca

Locations
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Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
University of Alberta
Canada Foundation for Innovation
Government of Alberta
Nestlé Health Science Spain
Olymel
Cargill
Investigators
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Principal Investigator: Carla Prado University of Alberta

Publications:
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Responsible Party: Carla Prado, Assistant Professor and CAIP Chair in Nutrition, Food and Health Director, Human Nutrition Research Unit Department of Agricultural, Food and Nutritional Science Division of Human Nutrition, University of Alberta
ClinicalTrials.gov Identifier: NCT02788955     History of Changes
Other Study ID Numbers: HREBA.CC-15-0193
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Carla Prado, University of Alberta:
Protein
Diet intervention
Muscle
Colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases