Stress and Menstrual Health

NCT07566260 | Not Yet Recruiting

• 1 other identifier: Pro00119656
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this experimental study is to determine how stressors that do not directly impact energy state or energy demands (hereafter called "non-energetic stressors") affect reproductive health in pre-menopausal women. It aims to do this by answering the following main questions: Do non-energetic stressors create a stress response? How does the stress response impact sex hormone concentration and thus menstrual dysfunction? If stress caused by non-energetic stressors does impact sex hormone concentration, does it do so primarily at the level of the brain or the level of the ovary? Participants will be enrolled in this study for 6 months. For two of these months, they will undergo a short stress intervention and provide samples to measure hormone concentration and total energy expenditure.

Conditions

Menstrual Dysfunction

Keywords

Stress; Menstruation; Energy Expenditure

Outcome Measures

Primary Outcomes (4)

• Total daily energy expenditure (TDEE)

  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.

  Baseline (Month 2), Intervention (Month 4)

• Basal metabolic rate (BMR)

  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.

  Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)

• Sex hormone concentration (estradiol)

  Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.

  Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)

• Sex hormone concentration (progesterone)

  Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.

  Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)

Secondary Outcomes (5)

• Stress hormone concentration (norepinephrine)

  Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)

• Stress hormone concentration (cortisol)

  Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)

• Stress hormone concentration (salivary alpha-amylase)

  Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)

• Sex hormone concentration (luteinizing hormone (LH))

  Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)

• Sex hormone concentration (follicle-stimulating hormone (FSH))

  Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)

Study Arms (3)

Heat Stress

EXPERIMENTAL

Heat stress via 70-80°C sauna exposure for 45-min sessions on 5 consecutive days (days 4-8 or 5-9 of follicular phase).

Other: Heat stress

Sleep Stress

EXPERIMENTAL

Sleep restriction to 4-6 hours/night for 5 consecutive nights (on days 3-8 or 4-9 of follicular phase).

Other: Sleep stress

Exercise Stress

EXPERIMENTAL

One-hour cycling at 60-75% predicted max HR for 5 consecutive days (days 4-8 or 5-9 of follicular phase).

Other: Exercise stress

Interventions

Heat stress OTHER

Stress-Heat participants will undergo supervised 40-min sessions in a 70-80˚C sauna

Heat Stress

Sleep stress OTHER

Stress-Sleep participants will be asked to sleep for between 4 and 6 hours per night, with compliance monitored via their activity monitors and self-reported sleep diaries. Participants will be requested to maintain normal wake cycles without midday sleep.

Sleep Stress

Exercise stress OTHER

Stress-Exercise participants will come to the Pontzer Lab to complete a one-hour cycling workout on a Lode Corival CPET ergometer/exercise bike at 60-75% predicted maximum heart rate.

Exercise Stress

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult pre-menopausal females, 18-45 years old
• Habitually sedentary (less than 60 minutes MVPA/week) for Exercise cohort

You may not qualify if:

• Individuals on hormonal birth control (oral contraception, injection, implant, or intrauterine device)
• Individuals with incidence in the last 6 months of childbirth, lactation, pregnancy, or functional hypothalamic amenorrhea (FHA)
• Individuals with reproductive disorders (e.g. endometriosis, polycystic ovarian syndrome (PCOS))
• Individuals taking thyroid medications
• Individuals who have undergone or are undergoing menopause
• MVPA \>60 min/week (for Exercise cohort)

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Interventions

Heat-Shock Response; Exercise Test

Intervention Hierarchy (Ancestors)

Stress, Physiological; Physiological Phenomena; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Herman Pontzer, PhD

  Duke University Evolutionary Anthropology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share