RECRUITING

Effects of Dietary Nitrate in Women With Secondary Amenorrhea

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effects of Dietary Nitrate in Women With Secondary Amenorrhea

Quick Facts

Study Start:2025-07
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07019129

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 44 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women age 18-44 years old
  2. * Missed \>3 consecutive periods in the last 12 months if previously regularly menstruating (average cycle 21-35 d) OR
  3. * Missed \>6 consecutive periods in the last 12 month if previously irregularly menstruating (spontaneous menstruation, average cycle \<21 or \> 35 d)
  1. * Unable to provide informed consent
  2. * Currently diagnosed with primary amenorrhea (no history of menstruation by age 15) or oligomenorrhea (menstrual cycle \>35 d or \<8 cycles per year)
  3. * Currently diagnosed with a chronic illness, including thyroid disease, hyperprolactinemia, Cushing syndrome, and/or poly-cystic ovarian syndrome (PCOS)
  4. * History or current clinical diagnosis of an eating disorder
  5. * Currently dieting
  6. * Weight instablility for the past 3 months
  7. * Previously undergone a revascularization procedure involving a vascular graft or stenting of the femoral or popliteal arteries
  8. * Currently at the time of screening, or in the past year, using hormonal contraceptives
  9. * Pregnancy
  10. * Epilepsy
  11. * Current antibiotic use
  12. * Current nicotine user
  13. * Stage II hypertension (resting blood pressure \>140/\>90)
  14. * Currently taking proton pump inhibitors, antacids, xanthine oxidase inhibitors, or on hormone replacement therapy
  15. * 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:
  16. * 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
  17. * Pain in chest when doing physical activity
  18. * In past month, chest pain when not doing physical activity
  19. * If participant has ever lost balance because of dizziness or has ever lost consciousness
  20. * Muscle, bone, or joint problem that could be made worse by physical activity
  21. * Currently on prescribed drugs for blood pressure or heart condition.
  22. * If the participant knows of any other reason he/she should not do physical activity.

Contacts and Locations

Study Contact

Andrew R Coggan, PhD
CONTACT
317-274-0656
mjfry@iu.edu

Principal Investigator

Andrew R Coggan, PhD
PRINCIPAL_INVESTIGATOR
Indiana University Indianapolis

Study Locations (Sites)

Indiana University Indianapolis
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Andrew R Coggan, PhD, PRINCIPAL_INVESTIGATOR, Indiana University Indianapolis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07
Study Completion Date2026-07

Study Record Updates

Study Start Date2025-07
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • dietary nitrate
  • secondary amenorrhea
  • muscle function

Additional Relevant MeSH Terms

  • Secondary Amenorrhea