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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Mitochondrial Energetics, Dietary Nitrate, Disuse Atrophy (Muscle) of Lower Leg

In brief

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.

Key facts

Study ID

NCT07161973

Run by

Indiana University

People needed

24

Starts

2026-01-30

Expected to finish

2026-12-31

Last updated by the study team

2026-02-23

Who can join

Age: 18 and older, up to 44. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Men age 18-44
• Above the minimum threshold of the IPAQ questionnaire
• Below the maximum threshold of the IPAQ questionnaire

You may not qualify if…

• Men and women <18 or >44 years of age
• Unable to provide informed consent
• Known clotting disorder
• Previous history of deep vein thrombosis
• Injury to either leg resulting in reduced mobility in the previous year
• Currently dieting or weight instability for the past 3 months
• Epileptic
• Pacemaker or other implantable heart device
• Currently taking antibiotics
• Current smoker
• Stage II hypertension (resting blood pressure >140/>90)
• Previously undergone a revascularization procedure involving a vascular graft or stenting of the femoral or popliteal arteries
• Those taking phosphodiesterase inhibitors (e.g., Viagra), proton pump inhibitors, antacids, xanthine oxidase inhibitors, hormonal contraceptives or on hormone replacement therapy
• An answer of yes to any of the seven questions on the first page of the Physical Activity Readiness Questionnaire (PAR-Q. These exclusions include the following:
• If participant's doctor has ever said that he/she has a heart condition and that he/she should only do physical activity recommended by a doctor
• Pain in chest when doing physical activity
• In past month, chest pain when not doing physical activity
• If participant has ever lost balance because of dizziness or has ever lost consciousness
• Muscle, bone, or joint problem that could be made worse by physical activity
• Currently on prescribed drugs for blood pressure or heart condition.
• If the participant knows of any other reason he/she should not do physical activity.

Where it is running

• Indiana University Indianapolis — Indianapolis, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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