Effects of Dietary Nitrate in Women With Secondary Amenorrhea

NCT07019129 | Recruiting

• 1 other identifier: 26781
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Secondary Amenorrhea

Keywords

dietary nitrate; secondary amenorrhea; muscle function

Outcome Measures

Primary Outcomes (2)

• Maximal knee extensor power

  Maximal power of the knee extensor (thigh) muscles as determined using isokinetic dynamometry

  Approximately 2-3 hours after beetroot ingestion

• Muscle reoxygenation kinetics

  Recovery rate constant (k) of muscle oxygenation following exercise as determined using NIRS (near-infrared spectroscopy) combined with brief intermittent arterial occlusion

  Approximately 2-3 hours after beetroot juice ingestion

Secondary Outcomes (3)

• Maximal knee extensor velocity

  Approximately 2-3 hours after beetroot juice ingestion

• Deoxygenation rate

  Approximately 2-3 hours after beetroot juice ingestion

• Reoxygenation rate

  Approximately 2-3 hours after beetroot juice ingestion

Other Outcomes (6)

• Baseline plasma nitrate/nitrite concentration

  Before beetroot juice ingestion

• Plasma nitrate/nitrite concentration at 1 hour

  1 hour after beetroot juice ingestion

• Plasma nitrate/nitrite concentration at 2 hours

  2 hours after beetroot juice ingestion

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Nitrate-free beetroot juice

Dietary Supplement: Placebo Beetroot Juice Without Nitrate

Nitrate

EXPERIMENTAL

Nitrate-rich beetroot juice

Dietary Supplement: Beetroot Juice - Active

Interventions

Beetroot Juice - Active DIETARY_SUPPLEMENT

Nitrate-rich beetroot juice

Nitrate

Placebo Beetroot Juice Without Nitrate DIETARY_SUPPLEMENT

Nitrate-poor beetroot juice

Placebo

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Indianapolis

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Interventions

Nitrates

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Nitric Acid; Nitrogen Compounds; Organic Chemicals

Study Officials

• Andrew R Coggan, PhD

  Indiana University Indianapolis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew R Coggan, PhD

CONTACT

317-274-0656; mjfry@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: September 5, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available upon completion of the study and publication of the final results.

Locations

US (1)