Stress and Menstrual Health

ConditionMenstrual Dysfunction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-45

SponsorDuke University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult pre-menopausal females, 18-45 years old

Habitually sedentary (less than 60 minutes MVPA/week) for Exercise cohort

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Heat stress
Other intervention
Stress-Heat participants will undergo supervised 40-min sessions in a 70-80˚C sauna
Sleep stress
Other intervention
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.
Exercise stress
Other intervention
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.

Treatment groups

600 Participants

are divided into 3 treatment groups

Group A: Heat StressExperimental treatment 1 intervention

Group B: Sleep StressExperimental treatment 1 intervention

Group C: Exercise StressExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame