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Secondary AmenorrheaNCT07019129

Effects of Dietary Nitrate in Women With Secondary Amenorrhea

A study testing Beetroot Juice - Active in people with Secondary Amenorrhea, run by Indiana University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 44 years, women only
Conditions the study is for
Secondary Amenorrhea
What is being tested?
Beetroot Juice - Active
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3 participants
Where
1 siteUnited States
Study dates
5 Sep 2025to 2 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 44 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 22Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Indiana University Indianapolis

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

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.

Read the detailed description

Due to excessive exercise, disordered attitudes toward eating, physical and psychological stress, and/or hormonal imbalances, young women may be predisposed to developing secondary amenorrhea. Secondary amenorrhea is defined as the absence of menses for at least 3 months in regularly menstruating women or at least 6 months in irregularly menstruating women [1]. This disorder of the hypothalamic-pituitary axis (HPO) is associated with a short-term lack of endogenous estradiol (E2), which may have negative health consequences [2-7]. For example, E2 plays an important role in regulating skeletal muscle mass and contractile function, including both strength and power [4]. In part, this is because E2 increases phosphorylation of the regulatory light chain of myosin, thereby enhancing muscle contractility [6, 8]. Lack of E2 also alters lipid and carbohydrate metabolism [9, 10], which may be due to the important role E2 plays in regulating mitochondrial function, more specifically respiration and efficiency. This impairment in metabolism and mitochondrial respiration could increase CVD risk and alter plasma levels of lipids, cortisol, and insulin [2, 9, 10]. Indeed, Ronkainen et al. [11] found that postmenopausal women not on hormone replacement therapy (HRT) have reduced skeletal muscle strength and power compared to those on HRT, whereas Kleis-Olsen et al. [12] reported similar findings with respect to fat mass and mitochondrial respiratory capacity. Younger women with secondary amenorrhea may also suffer from similar impairments due to E2 deficiency.

It has also been shown that short term lack of E2 compromises nitric oxide synthase (NOS) activity, which plays a critical role in cardiovascular health, exercise capacity, and vasomodulation and mitochondrial function within skeletal muscle [7, 13, 14]. Conversely, dietary nitrate supplementation can increase nitric oxide bioavailailbity, via an enterosalivary pathway in which nitrate is reduced to nitrite that in turn is further reduced to nitric oxide [15]. It has been demonstrated that dietary nitrate improves muscle contractility [16], exercise capacity and performance [15, 17], vascular function [18], and mitochondrial efficiency during exercise [5, 19, 20]. Indeed, we have found nitrate supplementation to be particularly effective in increasing muscular speed and power in postmenopausal women [21]. Increasing NO bioavailability via ingestion of nitrate therefore may have beneficial effects on both muscle function and mitochondrial function in women with secondary amenorrhea. To date, however, this hypothesis has not been tested.

Although the aforementioned research has highlighted the beneficial effects of dietary nitrate supplementation on muscle contractile function and mitochondrial respiration in various populations, no studies have examined the effects of this supplementation on these parameters in women with secondary amenorrhea. The proposed study will therefore provide a better understanding of the effects of dietary nitrate supplementation on muscle function and mitochondrial respiration in women with secondary amenorrhea, potentially improving health, recovery, and performance outcomes within this vulnerable population.

  1. Rebar, R., Evaluation of Amenorrhea, Anovulation, and Abnormal Bleeding, in Endotext, K.R. Feingold, et al., Editors. 2000: South Dartmouth (MA).
  2. Gupte, A.A., H.J. Pownall, and D.J. Hamilton, Estrogen: an emerging regulator of insulin action and mitochondrial function. J Diabetes Res, 2015. 2015: p. 916585.
  3. Ihalainen, J.K., et al., Beyond Menstrual Dysfunction: Does Altered Endocrine Function Caused by Problematic Low Energy Availability Impair Health and Sports Performance in Female Athletes? Sports Med, 2024. 54(9): p. 2267-2289.
  4. Chidi-Ogbolu, N. and K. Baar, Effect of Estrogen on Musculoskeletal Performance and Injury Risk. Front Physiol, 2018. 9: p. 1834.
  5. Larsen, F.J., et al., Dietary inorganic nitrate improves mitochondrial efficiency in humans. Cell Metab, 2011. 13(2): p. 149-59.
  6. Lai, S., et al., Estradiol modulates myosin regulatory light chain phosphorylation and contractility in skeletal muscle of female mice. Am J Physiol Endocrinol Metab, 2016. 310(9): p. E724-33.
  7. O'Donnell, E. and M.J. De Souza, The cardiovascular effects of chronic hypoestrogenism in amenorrhoeic athletes: a critical review. Sports Med, 2004. 34(9): p. 601-27.
  8. Greenberg, M.J., et al., The molecular effects of skeletal muscle myosin regulatory light chain phosphorylation. Am J Physiol Regul Integr Comp Physiol, 2009. 297(2): p. R265-74.
  9. An, J., et al., Sex- and endurance training-mediated cardiovascular protection through lipids during exercise. Trends Endocrinol Metab, 2024.
  10. Senoz, S., et al., Estrogen deprivation, rather than age, is responsible for the poor lipid profile and carbohydrate metabolism in women. Maturitas, 1996. 25(2): p. 107-14.
  11. Ronkainen, P.H., et al., Postmenopausal hormone replacement therapy modifies skeletal muscle composition and function: a study with monozygotic twin pairs. J Appl Physiol (1985), 2009. 107(1): p. 25-33.
  12. Kleis-Olsen, A.S., et al., Metabolic flexibility in postmenopausal women: Hormone replacement therapy is associated with higher mitochondrial content, respiratory capacity, and lower total fat mass. Acta Physiol (Oxf), 2024. 240(6): p. e14117.
  13. Fadel, P.J., W. Zhao, and G.D. Thomas, Impaired vasomodulation is associated with reduced neuronal nitric oxide synthase in skeletal muscle of ovariectomized rats. J Physiol, 2003. 549(Pt 1): p. 243-53.
  14. Tengan, C.H., G.S. Rodrigues, and R.O. Godinho, Nitric oxide in skeletal muscle: role on mitochondrial biogenesis and function. Int J Mol Sci, 2012. 13(12): p. 17160-84.
  15. Amdahl, M.B., A.W. DeMartino, and M.T. Gladwin, Inorganic nitrite bioactivation and role in physiological signaling and therapeutics. Biol Chem, 2019. 401(1): p. 201-211.
  16. Coggan, A.R. and L.R. Peterson, Dietary Nitrate Enhances the Contractile Properties of Human Skeletal Muscle. Exerc Sport Sci Rev, 2018. 46(4): p. 254-261.
  17. Flueck, J.L., et al., Is beetroot juice more effective than sodium nitrate? The effects of equimolar nitrate dosages of nitrate-rich beetroot juice and sodium nitrate on oxygen consumption during exercise. Appl Physiol Nutr Metab, 2016. 41(4): p. 421-9.
  18. Craig, J.C., et al., Effect of dietary nitrate supplementation on conduit artery blood flow, muscle oxygenation, and metabolic rate during handgrip exercise. J Appl Physiol (1985), 2018. 125(2): p. 254-262.
  19. Bailey, S.J., et al., Dietary nitrate supplementation enhances muscle contractile efficiency during knee-extensor exercise in humans. J Appl Physiol (1985), 2010. 109(1): p. 135-48.
  20. Pappas, G., M.L. Wilkinson, and A.J. Gow, Nitric oxide regulation of cellular metabolism: Adaptive tuning of cellular energy. Nitric Oxide, 2023. 131: p. 8-17.
  21. Coggan, A.R., et al., Dietary nitrate-induced increases in human muscle power: high versus low responders. Physiol Rep, 2018. 6(2).
  22. Jungersten, L., et al., Plasma nitrate as an index of nitric oxide formation in man: analyses of kinetics and confounding factors. Clin Physiol, 1996. 16(4): p. 369-79.
  23. Govoni, M., et al., The increase in plasma nitrite after a dietary nitrate load is markedly attenuated by an antibacterial mouthwash. Nitric Oxide, 2008. 19(4): p. 333-7.
  24. Joint FAO/WHO Expert Committee on Food Additives. Meeting (61st: 2003, R., Italy) \& International Programme on Chemical Safety., Safety evaluation of certain food additives and contaminants/prepared by the sixty-first meeting of the Joint FAO/WHO Expert Committee on Food Additives (JEFCA). 2004.
  25. Goodman, J., S. Thomas, and J.F. Burr, Physical activity series: cardiovascular risks of physical activity in apparently healthy individuals: risk evaluation for exercise clearance and prescription. Can Fam Physician, 2013. 59(1): p. 46-9, e6-e10.
  26. Sumner, M.D., et al., Near Infrared Spectroscopy Measurements of Mitochondrial Capacity Using Partial Recovery Curves. Front Physiol, 2020. 11: p. 111.
  27. Gallardo EJ, Gray DA, Hoffman RL, Yates BA, Moorthi RN, Coggan AR. Dose-response effect of dietary nitrate on muscle contractility and blood pressure in older subjects: a pilot study. J Gerontol A Biol Sci Med Sci 2021; 76:591-598.
  28. Zoughaib WS, Hoffman RL, Yates BA, Moorthi RN, Lim K, Coggan AR. Short-term beetroot juice supplementation improves muscle contractility but does not reduce blood pressure or oxidative stress in 65-79 y old men and women. Nitric Oxide 20
Being tested
Beetroot Juice - Active, Placebo Beetroot Juice Without Nitrate
Keywords
dietary nitrate, secondary amenorrhea, muscle function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beetroot Juice - ActiveDietary supplement

    Nitrate-rich beetroot juice

  • Placebo Beetroot Juice Without NitrateDietary supplement

    Nitrate-poor beetroot juice

Study groups in NCT07019129
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNitrate-free beetroot juice
Receives: Dietary Supplement: Placebo Beetroot Juice Without Nitrate
NitrateExperimentalNitrate-rich beetroot juice
Receives: Dietary Supplement: Beetroot Juice - Active

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal knee extensor power

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

    Measured: Approximately 2-3 hours after beetroot ingestion

  2. 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

    Measured: Approximately 2-3 hours after beetroot juice ingestion

Secondary outcomes (3)
  1. Maximal knee extensor velocity

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

    Measured: Approximately 2-3 hours after beetroot juice ingestion

  2. Deoxygenation rate

    Rate of deoxygenation of the knee extensor (thigh) muscles during 5 minutes of continuous arterial occlusion as determined using NIRS (near-infrared spectroscopy)

    Measured: Approximately 2-3 hours after beetroot juice ingestion

  3. Reoxygenation rate

    Rate of reoxygenation of the knee extensor (thigh) muscles following 5 minutes of continuous arterial occlusion as determined using NIRS (near-infrared spectroscopy)

    Measured: Approximately 2-3 hours after beetroot juice ingestion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2025
  2. Study start5 Sep 2025
  3. Primary completion2 Apr 2026
  4. Study completion2 Apr 2026

Why it stopped: Unable to recruit adequate number of participants

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07019129
Sponsor's protocol ID
26781
Status last verified
Jun 2026
First submitted
5 Jun 2025
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All non-PHI individual participant data will be shared upon reasonable request.

Questions about this trial

What is this clinical trial studying?

A study testing Beetroot Juice - Active in people with Secondary Amenorrhea, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Unable to recruit adequate number of participants). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal knee extensor power (time frame: Approximately 2-3 hours after beetroot ingestion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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