NCT07161973 · Indiana University
Effect of Dietary Nitrate on Immobilization-induced Changes in Skeletal Muscle in Young Healthy Men
What this study is about
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.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
Beetroot Juice - Active
Nitrate-rich beetroot juice
DIETARY_SUPPLEMENT
Placebo Beetroot Juice Without Nitrate
Nitrate-free beetroot juice
Primary outcome measures
Muscle mitochondrial function
Time frame: 14 days
Muscle mitochondrial respiratory capacity assessed in vitro using high resolution respirometry and in vivo using a near infrared spectroscopy/occlusion protocol
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Indianapolis, Indiana
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 23, 2026 · Source of record for eligibility and locations