RECRUITING

Muscle Response to Different Amounts of Dietary Protein During Leg Immobilization

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Individuals who sustain musculoskeletal injuries (MSKI) can experience a rapid loss of muscle mass due to declines in muscle loading and activation that occur post-injury (i.e., disuse atrophy). Loss of muscle under these conditions is attributed to a persistent negative net muscle protein balance (muscle protein synthesis \[MPS\] \< muscle protein breakdown) that results, in part, from declines in postprandial MPS (i.e., anabolic resistance). Nutritional interventions that enhance postprandial MPS may be used to overcome disuse-induced anabolic resistance and preserve muscle mass to accelerate recovery and improve recovery outcomes. While supplemental protein has been explored as a potential countermeasure to disuse-induce anabolic resistance, the observed efficacy of such interventions has been mixed. Equivocal findings across studies may be attributed, in part, to an insufficient understanding of what constitutes an effective protein-based intervention. Importantly, no study to date has determined an optimal protein dose for overcoming disuse-induce anabolic resistance, or if there is a threshold for maximally stimulating postprandial MPS under disuse conditions. Therefore, the objective of this work is to determine rates of MPS at rest and in response to standard (20 g) or high (40 g) doses of whey protein during knee immobilization (DISUSE) compared with standard activity (ACTIVE)

Official Title

The Effects of Varying Protein Intakes on Muscle Protein Synthesis During Injury-Mediated Muscle Disuse

Quick Facts

Study Start:2025-09-01
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07069426

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:17 Years to 39 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women aged 18-39 years (17-39 years if military personnel)
  2. * Body mass index (BMI) between 18.5-32 kg/m2
  3. * Routinely participate in aerobic and/or resistance exercise at least 2 days per week.
  4. * Willing to refrain from alcohol, smoking, smokeless nicotine products (includes e-cigarettes, vaping, chewing tobacco), and dietary supplements (i.e., vitamin D, probiotics) 24 hours before and during immobilization and final testing day.
  5. * Willing to only consume caffeine products provided by study staff during the study.
  6. * Supervisor approval for federal civilian employees and non-SRV active-duty military personnel stationed at NSSC.
  7. * Biological females must have normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or on continuous hormonal contraception (i.e., IUD or oral contraceptives without placebo).
  1. * Musculoskeletal injuries that may interfere with the safe use of crutches.
  2. * Personal or family history of thrombosis, or prior diagnosis of deep vein thrombosis (DVT) or pulmonary embolism (PE).
  3. * Metabolic or cardiovascular abnormalities, gastrointestinal disorders, neuromuscular disorders, lower-limb amputation, or muscle/bone wasting disorders (e.g., diabetes, cardiovascular disease, Crohn's disease, etc.).
  4. * Taking medication that affects macronutrient utilization (i.e., statins, corticosteroids, weight loss medications such as Ozempic, etc.).
  5. * Significantly abnormal blood clotting as determined by USARIEM Office of Medical Oversight (OMSO) or home duty station medical support (HMS).
  6. * Allergy to lidocaine (or similar local anesthetic).
  7. * Present condition of alcoholism, anabolic steroid use, or other substance abuse issues as determined by OMSO or HMS.
  8. * Blood donation within 8-wk of beginning the study.
  9. * Pregnant, trying to become pregnant, and/or breastfeeding (results of urine pregnancy test and self-report for breastfeeding will be obtained before body composition testing).
  10. * Unwilling or unable to consume study diets or foods provided due to personal preference and/or food allergies.
  11. * Unwilling or unable to adhere to study physical restrictions (i.e., no structured physical activity or recreational activity beyond activities of daily living) 24 hours before and during immobilization, and the final testing day.
  12. * Unwilling or unable to keep the knee brace on and walk with crutches during the immobilization phase.

Contacts and Locations

Study Contact

Emily E Howard, PhD
CONTACT
508-206-2309
emily.e.howard14.civ@health.mli

Study Locations (Sites)

US Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760
United States

Collaborators and Investigators

Sponsor: United States Army Research Institute of Environmental Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-01
Study Completion Date2026-09

Study Record Updates

Study Start Date2025-09-01
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • muscle protein synthesis
  • muscle disuse
  • muscle disuse atrophy
  • immobilization
  • anabolic resistance
  • dose-response

Additional Relevant MeSH Terms

  • Muscle Disuse
  • Muscle Disuse Atrophy