Effect of Dietary Nitrate on Immobilization-induced Changes in Skeletal Muscle in Young Healthy Men (NCT07161973) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Dietary Nitrate on Immobilization-induced Changes in Skeletal Muscle in Young Healthy Men
United States24 participantsStarted 2026-01-30
Plain-language 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.
Who can participate
Age range
18 Years – 44 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men age 18-44
* Above the minimum threshold of the IPAQ questionnaire
* Below the maximum threshold of the IPAQ questionnaire
Exclusion Criteria:
* 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 m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.