Stress and Menstrual Health Study
This study is looking at how different types of stress, like heat, sleep deprivation, or exercise, might affect menstrual health in women. Researchers want to understand if these stressors, which don't directly change your energy levels, can create a stress response in your body. They will then see if this stress response impacts your sex hormone levels (like estradiol) and potentially lead to menstrual problems. The study will also explore if any changes in sex hormones happen in the brain or the ovaries. You may be eligible if you are a pre-menopausal woman between 18 and 45 years old, and not using hormonal birth control or recently pregnant/breastfeeding. The study aims to enroll 600 participants.
- Study design
- This is an interventional study planning to enroll 600 women. Participants will be assigned to one of three stress interventions: heat stress (sauna), sleep stress (reduced sleep), or exercise stress (cycling workout).
- What's involved
- You would participate in the study for 6 months. This includes baseline measurements, a control period, the intervention period, and a follow-up period. Specific activities depend on your assigned stress group, such as 40-minute sauna sessions, monitoring sleep, or a one-hour cycling workout.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for one month after the intervention period, with measurements taken at Month 6.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Stress and Menstrual Health
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Herman Pontzer, PhD · PRINCIPAL_INVESTIGATOR · Duke University Evolutionary Anthropology Department
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Total daily energy expenditure (TDEE)Baseline (Month 2), Intervention (Month 4)
TDEE (kcal) will be measured over a 7-day period during the Baseline and first Intervention month using the doubly-labeled water (DLW) method. DLW is a safe and reliable method for capturing free-living TDEE and has been validated for human studies. The DLW method adds a known amount of stable isotopes, oxygen-18 (18O) and deuterium (2H), to a participant's total body water (TBW) via ingestion and then measures the depletion rate of these isotopes as they are removed from the body via urine and exhalation.
- Basal metabolic rate (BMR)Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
BMR (kcal/d) will be estimated via indirect calorimetry. Participants will be asked to come in for a lab visit on a day of their choice within 2-7 days post-ovulation prior to consuming breakfast or any non-water beverage and after having refrained from exercise for 24 hours pre-measurement. Participants will lie on an exam bed in the Pontzer Lab and have a clear plastic hood connected to a COSMED Quark RMR machine placed over their head for approximately 25-30 minutes. This hood will collect exhaled air, which will be measured for CO2 production to estimate BMR.
- Sex hormone concentration (estradiol)Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
- Sex hormone concentration (progesterone)Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.