Stress and Menstrual Health
4. september 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
600
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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North Carolina
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Durham, North Carolina, Forente stater, 27708
- Rekruttering
- Duke University
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Ta kontakt med:
- Mary Joy
- Telefonnummer: 7249317802
- E-post: mary.joy@duke.edu
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Basal metabolic rate (BMR)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Stress hormone concentration (norepinephrine)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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))
Tidsramme: 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))
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Herman Pontzer, PhD, Duke University Evolutionary Anthropology Department
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
28. mai 2026
Primær fullføring (Antatt)
1. august 2028
Studiet fullført (Antatt)
1. august 2029
Datoer for studieregistrering
Først innsendt
29. april 2026
Først innsendt som oppfylte QC-kriteriene
29. april 2026
Først lagt ut (Faktiske)
5. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. september 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00119656
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