Study reveals how cutting calories disrupts Women's periods
NCT ID NCT02858336
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 5 times
Summary
This study looked at how diet and exercise changes affect hormones and menstrual cycles in healthy women aged 18-28. Participants followed special diets and exercise programs while researchers measured hormone levels. The goal was to better understand a condition called functional hypothalamic amenorrhea, where periods stop temporarily due to the brain not directing the reproductive system properly.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
38 people
The number who actually took part.
- Started
-
Jan 2017
- Finished
-
Jun 2019
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 28 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: Participants will be enrolled with distribution across race. Each potential participant must meet all of the following inclusion criteria in order to be eligible to enroll in the study: 1. Female 2. Between 18 and 28 years of age (inclusive) 3. Reported menarche between the ages of 11 and 14 years 4. Gynecological age of \<= 14 years 5. A history of self-reported regular menstrual cycles when not on contraceptive medication of between 25 and 35 days (inclusive) at prescreen and knowledge of date of onset of menses before the screening visit 6. A BMI of 18.5 to 27 kg x m\^2 and a weight \>= 93 lbs. 7. Agrees to use barrier contraception method for the duration of the study and the follow up period 8. Agrees to abstain from alcohol consumption during both 5-day diet/exercise study interventions 9. Agrees to abstain from donating blood during the study and within 30 days of completing the study 10. Agrees to abstain from biotin supplements for the duration of the study 11. Is willing and able to fulfill the requirements of the protocol and to provide informed consent 12. Able to speak and read English 13. Lives within 50 miles of the Clinical Research Unit EXCLUSION CRITERIA: A potential participant meeting any of the following exclusion criteria is not eligible to enroll in the study: 1. Currently lactating or pregnant or planning on becoming pregnant for the duration of the study 2. Has ever given birth 3. History in the past 3 months of dieting or weight loss amounting to greater than 2 kg 4. \> 4 hours per week of aerobic exercise for the past 3 months 5. Has initiated training for an athletic sport or event in the past 3 months that, in the opinion of the investigator, may interfere with the results of the study 6. Currently using hormone-based contraception, including those administered orally, vaginally, via injection, sub-dermally, or transdermally 7. Current use of medications or supplements that may interfere with the results of the study, including: i.Steroids ii.Hormone-based contraception iii.Sleeping pills iv.Homeopathic substances (e.g. Chinese herbs, protein or other powders, and other-the-counter extracts) v.Stimulants (e.g. Ritalin) vi.Antidepressants or anti-epileptic medications or centrally acting anti-hypertensive medications 8. Current use of recreational drugs (alcohol intake will be monitored and excluded during the two intervention periods) 9. Unable to consume food containing dairy or nuts 10. Has regular overnight awake periods, for example overnight or rotating shift work, that will continue during the study, at the discretion of the investigator 11. Has currently or has a history of any of the following: autoimmune, heart, liver, renal disease, diabetes, or another health condition deemed by the PI to be a contraindication to study participation. Additional Eligibility Criteria to be Met Prior to Start of Intervention(s): Criteria 1 Habitual energy intake between 35-55 kcal/kg LBM\*day Criteria 2 VO2max \<= 40 ml/kg/min with the option to increase this at the discretion of the PI, depending on the current and past exercise level of the participant. Criteria 3 Hemoglobin, prolactin and TSH within normal female range for testing laboratory. Criteria 4 Ovulation confirmed in the cycle before each study intervention by self-reported positive urine test, ultrasound and/or progesterone blood-levels
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Functional hypothalamic amenorrhea are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, 27709, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Weekly shot could replace daily needles for kids with growth hormone deficiency
- Could a targeted drug delay prostate cancer progression?
- Lifting weights, not rest: new study tests exercise as treatment for lost periods
- New online program aims to help women with missed periods
- New study combines eastern and western medicine to restore periods in women
- VR and brain music may take the edge off childbirth