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New treatment option for Muscle Disuse
Official title Muscle Response to Different Amounts of Dietary Protein During Leg Immobilization
ClinicalTrials.gov ID: NCT07069426
What this study is testing
- What it's testing
- 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).
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 17 to 39. Healthy volunteers may be eligible.
You may be able to join if
- Men and women aged 18-39 years (17-39 years if military personnel)
- Body mass index (BMI) between 18.5-32 kg/m2
- 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), and dietary supplements...
- Willing to only consume caffeine products provided by study staff during the study.
You likely can't join if
- 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...
- Taking medication that affects macronutrient utilization (i.e., statins, corticosteroids, weight loss medications such as Ozempic, etc.).
- Significantly abnormal blood clotting as determined by USARIEM Office of Medical Oversight (OMSO) or home duty station medical support (HMS).
- Allergy to lidocaine (or similar local anesthetic).
See the full eligibility criteria
- Men and women aged 18-39 years (17-39 years if military personnel)
- Body mass index (BMI) between 18.5-32 kg/m2
- 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), and dietary supplements (i.e., vitamin D, probiotics) 24 hours before and during immobilization and...
- Willing to only consume caffeine products provided by study staff during the study.
- Supervisor approval for federal civilian employees and non-SRV active-duty military personnel stationed at 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., IUD or oral contraceptives without...
- 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.).
- Taking medication that affects macronutrient utilization (i.e., statins, corticosteroids, weight loss medications such as Ozempic, etc.).
- Significantly abnormal blood clotting as determined by USARIEM Office of Medical Oversight (OMSO) or home duty station medical support (HMS).
- Allergy to lidocaine (or similar local anesthetic).
- Present condition of alcoholism, anabolic steroid use, or other substance abuse issues as determined by OMSO or HMS.
- 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...
- Unwilling or unable to keep the knee brace on and walk with crutches during the immobilization phase.
The study team makes the final eligibility decision.
Where it's taking place
- Natick, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 17 years to 39 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Natick, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.