Beetroot nitrate for muscle power and exercise recovery in women with secondary amenorrhea
Effects of Dietary Nitrate in Women With Secondary Amenorrhea
This test sees if drinking nitrate-rich beetroot juice helps improve muscle power and exercise recovery in women aged 18–44 who have secondary amenorrhea.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT07019129 on ClinicalTrials.gov |
What this trial studies
This interventional study gives eligible women either beetroot juice containing dietary nitrate or a nitrate-free placebo and measures effects on muscle function and post-exercise oxygen recovery. Participants are adults with secondary amenorrhea and are compared on performance and metabolic markers that may be affected by low estrogen and reduced nitric oxide. The trial uses a placebo-controlled design to isolate the effect of dietary nitrate as an alternative source of nitric oxide. Outcomes include measures of muscle power, oxygen recovery after exercise, and related metabolic or vascular biomarkers.
Who should consider this trial
Good fit: Ideal candidates are women aged 18–44 with secondary amenorrhea (missed >3 consecutive periods if previously regular or >6 if previously irregular) who do not have excluded chronic conditions and can attend study visits at the Indianapolis site.
Not a fit: People unlikely to benefit include those with primary amenorrhea, oligomenorrhea, diagnosed chronic endocrine conditions (like PCOS or thyroid disease), current or past eating disorders, or anyone outside the specified age or eligibility criteria.
Why it matters
Potential benefit: If successful, this approach could improve muscle strength, power, and exercise recovery for women whose menstruation has stopped and who have low estrogen-related changes.
How similar studies have performed: Previous research has shown that dietary nitrate (beetroot) can improve exercise performance and muscle oxygenation in other groups and that estrogen replacement can benefit muscle function, but using nitrate specifically to counteract changes from secondary amenorrhea is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women age 18-44 years old * Missed \>3 consecutive periods in the last 12 months if previously regularly menstruating (average cycle 21-35 d) OR * Missed \>6 consecutive periods in the last 12 month if previously irregularly menstruating (spontaneous menstruation, average cycle \<21 or \> 35 d) Exclusion Criteria: * Unable to provide informed consent * Currently diagnosed with primary amenorrhea (no history of menstruation by age 15) or oligomenorrhea (menstrual cycle \>35 d or \<8 cycles per year) * Currently diagnosed with a chronic illness, including thyroid disease, hyperprolactinemia, Cushing syndrome, and/or poly-cystic ovarian syndrome (PCOS) * History or current clinical diagnosis of an eating disorder * Currently dieting * Weight instablility for the past 3 months * Previously undergone a revascularization procedure involving a vascular graft or stenting of the femoral or popliteal arteries * Currently at the time of screening, or in the past year, using hormonal contraceptives * Pregnancy * Epilepsy * Current antibiotic use * Current nicotine user * Stage II hypertension (resting blood pressure \>140/\>90) * Currently taking proton pump inhibitors, antacids, xanthine oxidase inhibitors, 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) indicating that the participant is not physically ready for exercise without a medical exam. 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: mjfry@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.