Dietary nitrate to limit muscle loss during leg immobilization in young men
Effect of Dietary Nitrate on Immobilization-induced Changes in Skeletal Muscle
This test will see if drinking nitrate-rich beetroot juice prevents muscle loss and metabolic changes during short-term leg immobilization in healthy men aged 18–44.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Male |
| Sponsor | Indiana University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT07161973 on ClinicalTrials.gov |
What this trial studies
Healthy men will undergo short-term lower-leg immobilization to model disuse-induced muscle wasting while receiving either nitrate-rich beetroot juice or a nitrate-depleted placebo. Participants are assigned to one of the two beverage groups for the duration of the immobilization period. Researchers will measure muscle fiber size, whole-muscle size, strength, and mitochondrial energetics before and after immobilization. The goal is to determine whether dietary nitrate can preserve muscle mass, strength, and energy metabolism during disuse.
Who should consider this trial
Good fit: Healthy men aged 18–44 who meet activity-level screening criteria and are willing to undergo short-term leg immobilization and study visits are the intended participants.
Not a fit: People outside the 18–44 age range, women, current smokers, or those with excluded health conditions or taking prohibited medications are unlikely to benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, dietary nitrate could help preserve muscle size and function during periods of limb immobilization and speed recovery after injury or surgery.
How similar studies have performed: Some animal studies and small human trials suggest dietary nitrate can improve blood flow and mitochondrial function, but applying it to prevent immobilization-induced muscle wasting in humans is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 this trial is running
Indianapolis, Indiana
- Indiana University Indianapolis — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Andrew R Coggan, PhD — Indiana University Indianapolis
- Study coordinator: Andrew R Coggan, PhD
- Email: acoggan@iu.edu
- Phone: 317-274-0656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.