Protein Recommendation to Increase Muscle

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2022-04-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Modifying Your Diet to Support Muscle During Cancer Treatment.

NCT03010657

Non-Small Cell Lung Cancer

COMPLETED NA

Protein Needs Study

NCT04144907

Colorectal Cancer Breast Cancer

RECRUITING NA

Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer

NCT05650827

Gastro-esophageal Cancer

ACTIVE_NOT_RECRUITING NA

Immobilization and Protein Supplementation (IM-PRO)

NCT01588808

Disuse Atrophy Aging

COMPLETED NA

Protein Ingestion and Skeletal Muscle Atrophy

NCT03797781

Muscle Atrophy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal Protein Diet

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.

Group Type ACTIVE_COMPARATOR

Dietary counselling

Intervention Type BEHAVIORAL

Dietary Protein

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Dietary counselling

Intervention Type BEHAVIORAL

Dietary Protein

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dietary counselling

Intervention Type BEHAVIORAL

Dietary Protein

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No