TerminatedNot Applicable

Effects of Dietary Nitrate in Women With Secondary Amenorrhea

Stopped: Unable to recruit adequate number of participants

United States3 participantsStarted 2025-09-05

Plain-language summary

Excessive exercise, disordered attitudes toward eating, physical and psychological stress, and/or hormonal imbalances may result in cessation of menstruation (secondary amenorrhea). The accompanying lack of estrogen may impair muscle power and oxygen recovery after exercise by reducing nitric oxide levels. The purpose of this study is to determine whether ingestion of beetroot juice containing nitrate, an alternative source of nitric oxide, can help reverse these changes.

Who can participate

Age range

18 Years – 44 Years

Sex

FEMALE

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: * 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 ex…

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?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

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.

What they're measuring

Maximal knee extensor power

Timeframe: Approximately 2-3 hours after beetroot ingestion

Muscle reoxygenation kinetics

Timeframe: Approximately 2-3 hours after beetroot juice ingestion

Trial details

NCT IDNCT07019129

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-02

View on ClinicalTrials.gov More Secondary Amenorrhea trials