Search / Trial NCT06228742

Molecular Mechanisms Underlying Anabolic Resistance to Protein Intake During Muscle Disuse

Launched by UNITED STATES ARMY RESEARCH INSTITUTE OF ENVIRONMENTAL MEDICINE · Jan 18, 2024

Trial Information

Current as of December 21, 2024

Completed

Keywords

ClinConnect Summary

This clinical trial is studying how muscle disuse affects the body's ability to respond to protein intake, particularly when a muscle is not being used. In this study, 12 healthy adults will have one leg immobilized for five days using a knee brace while the other leg remains active. Researchers will examine the muscles of both legs to see how they react to consuming protein after the immobilization period. The goal is to understand the biological changes that happen during muscle disuse, which could help develop better ways to counteract muscle loss in the future.

To participate in this study, individuals should be between 18 and 39 years old, have a healthy body weight, and regularly exercise at least twice a week. Participants need to be in good health and free from chronic illnesses or injuries that could interfere with the study. Those who join can expect to wear a knee brace, use crutches, and follow specific dietary restrictions during the trial. This research is important because it aims to find ways to improve muscle health for people who may not be able to use their muscles for extended periods.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Men and women aged 18-39 years.
  • Body mass index (BMI) between 18.5-30 kg/m2
  • Healthy without evidence of chronic illness (e.g., diabetes, cardiovascular disease, Crohn's disease) or musculoskeletal injury as determined by the USARIEM Office of Medical Oversight (OMSO) or home duty station medical support.
  • Routinely participate in aerobic and/or resistance exercise at least 2 days per week.
  • Willing to refrain from alcohol, smoking, smokeless nicotine products (includes e-cigarettes, vaping, chewing tobacco), caffeine, and dietary supplements (i.e., vitamin D, probiotics) during the run-in diet, immobilization phase, and final testing day of the study.
  • Supervisor approval for federal civilian employees and non-human research volunteer (HRV) active-duty military personnel stationed at Natick Soldier System Center (NSSC).
  • 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., intrauteraine device (IUD) or oral contraceptives without placebo).
  • Exclusion Criteria:
  • Musculoskeletal injuries that may interfere with the safe use of crutches.
  • Personal or family history of thrombosis, or prior diagnosis of deep vein thrombosis (DVT) or pulmonary embolism (PE).
  • 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.).
  • Significantly abnormal blood clotting as determined by OMSO or home duty station medical support.
  • Allergy to lidocaine (or similar local anesthetic)
  • Present condition of alcoholism, anabolic steroid use, or other substance abuse issues as determined by OMSO or home duty station medical support.
  • Blood donation within 8-wk of beginning the study.
  • 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).
  • Unwilling or unable to consume study diets or foods provided due to personal preference and/or food allergies.
  • 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.
  • Unwilling or unable to keep the knee brace on and walk with crutches during the immobilization phase.

Trial Officials

Emily E Howard, PhD

Principal Investigator

US Army Research Institute of Environmental Medicine

About United States Army Research Institute Of Environmental Medicine

The United States Army Research Institute of Environmental Medicine (USARIEM) is a premier military research organization dedicated to enhancing the health and performance of soldiers through innovative scientific investigation. With a focus on environmental physiology, nutrition, and injury prevention, USARIEM conducts rigorous clinical trials and studies aimed at optimizing soldier readiness and resilience in diverse operational conditions. By integrating advanced research methodologies and interdisciplinary collaboration, USARIEM plays a crucial role in informing military policies and practices, ultimately contributing to the well-being and effectiveness of military personnel.

Locations

Natick, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0