Stress and Menstrual Health
4 september 2026 bijgewerkt door: Duke University
The Influence of Non-energetic Stressors on Human Menstrual Function
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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The Reproductive Suppression Model posits that due to the high cost and failure rate of human reproduction, the female body maximizes lifetime reproductive fitness by suppressing reproduction during poor conditions (where likelihood of offspring survival is low) until conditions are more favorable.
The hormonal mechanism for this suppression when calories are scarce and the female body is in low energy availability (LEA) has been studied.
However, the mechanism for this suppression in the presence of stressors unrelated to low energy availability, but which could still negatively impact offspring survival, is much less clear.
The investigators define such stressors, which do not impact energy state or energetic demands, as "non-energetic stressors."
Thus, the aim of this study is to determine if non-energetic stressors drive reproductive suppression in humans.
The investigators will assess this by testing the impact of a stress intervention on the stress hormones cortisol and norepinephrine, and in turn if the levels of these stress hormones predict the levels of sex hormones associated with the menstrual cycle.
Finally, the investigators will assess if changes in stress hormones change total and basal energy expenditure.
Studietype
Ingrijpend
Inschrijving (Geschat)
600
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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North Carolina
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Durham, North Carolina, Verenigde Staten, 27708
- Werving
- Duke University
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Contact:
- Mary Joy
- Telefoonnummer: 7249317802
- E-mail: mary.joy@duke.edu
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Ja
Beschrijving
Inclusion Criteria:
- Adult pre-menopausal females, 22-38 years old with a BMI of 18.5-30.0
- Habitually sedentary (less than 60 minutes MVPA/week) for Exercise cohort
Exclusion Criteria:
- 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 a BMI <18.5 or >30.0
- 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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Heat Stress
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).
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Stress-Heat participants will undergo supervised 40-min sessions in a 70-80˚C sauna
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Experimenteel: Sleep Stress
Sleep restriction to 4-6 hours/night for 5 consecutive nights (on days 3-8 or 4-9 of follicular phase).
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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.
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Experimenteel: Exercise Stress
One-hour cycling at 60-75% predicted max HR for 5 consecutive days (days 4-8 or 5-9 of follicular phase).
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Basal metabolic rate (BMR)
Tijdsspanne: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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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.
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Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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Sex hormone concentration (estradiol)
Tijdsspanne: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
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Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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Sex hormone concentration (progesterone)
Tijdsspanne: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
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Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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Total daily energy expenditure (TDEE)
Tijdsspanne: Control (Month 3), Intervention (Month 4)
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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.
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Control (Month 3), Intervention (Month 4)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Stress hormone concentration (norepinephrine)
Tijdsspanne: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
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Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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Stress hormone concentration (cortisol)
Tijdsspanne: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
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Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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Stress hormone concentration (salivary alpha-amylase)
Tijdsspanne: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
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Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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Sex hormone concentration (luteinizing hormone (LH))
Tijdsspanne: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
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Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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Sex hormone concentration (follicle-stimulating hormone (FSH))
Tijdsspanne: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
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Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Herman Pontzer, PhD, Duke University Evolutionary Anthropology Department
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
28 mei 2026
Primaire voltooiing (Geschat)
1 augustus 2028
Studie voltooiing (Geschat)
1 augustus 2029
Studieregistratiedata
Eerst ingediend
29 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 april 2026
Eerst geplaatst (Werkelijk)
5 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 september 2026
Laatste update ingediend die voldeed aan QC-criteria
4 september 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Pro00119656
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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