Protein Recommendation to Increase Muscle

Official Title

Decreasing the Burden of Sarcopenia in Cancer Through Targeted Nutrition Intervention: A Feasibility Study

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.

Trial Description

Primary Outcome:

• Change/maintenance in muscle mass

Secondary Outcome:

• Change in 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 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, as well as portions of pre-cooked meat 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.

View this trial on ClinicalTrials.gov