Clinical Trial

Effect of Dietary Nitrate on Immobilization-induced Changes in Skeletal Muscle in Young Healthy Men

Recruiting
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Summary
Diminished use of skeletal muscle, such as occurs with many chronic diseases (e.g., heart failure or cancer cachexia), denervation, bedrest, immobilization (e.g., limb casting or bracing), etc., is a common clinical condition affecting untold millions of individuals each year. Such disuse leads to a rapid decline in muscle fiber area and hence whole muscle size, contributing to a decrease in strength, speed, and power as well as alterations in energy metabolism. Collectively, these changes lead to reduced physical function and contribute to the seriousness of any disease, illness (e.g., pneumonia), surgery (e.g., joint replacement), or injury (e.g., broken bone) accompanied by decreased muscular activity. Currently, there are no effective pharmacological treatments to prevent disuse-associated muscle wasting in humans. The above-described effects of disuse appear to be due, at least in part, to a decrease in nitric oxide (NO) bioavailability. Reduced synthesis of NO and/or increased NO destruction (due to increased production of oxygen free radicals) likely contributes to the mitochondrial changes, energetic abnormalities, and muscle atrophy resulting from immobilization. The objective of this study is to investigate the potential benefits of dietary nitrate supplementation on immobilization-induced changes in muscle contractile function and mitochondrial respiratory capacity in young healthy men. Our disuse-induced muscle atrophy model will involve wearing a knee brace for a period of 14 d.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-09-04; most recent amendment 2026-02-20.
Status change: Not Yet Recruiting → Recruiting 2026-02-20
Trial Details
NCT Number NCT07161973
Lead Sponsor Indiana University
Conditions Mitochondrial Energetics, Dietary Nitrate, Disuse Atrophy (Muscle) of Lower Leg
Enrollment 24 participants
Start Date 2026-01-30
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-23