Stress and Menstrual Health
2026년 9월 4일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
600
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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North Carolina
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Durham, North Carolina, 미국, 27708
- 모병
- Duke University
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연락하다:
- Mary Joy
- 전화번호: 7249317802
- 이메일: mary.joy@duke.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Basal metabolic rate (BMR)
기간: 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)
기간: 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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Stress hormone concentration (norepinephrine)
기간: 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)
기간: 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)
기간: 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))
기간: 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))
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Herman Pontzer, PhD, Duke University Evolutionary Anthropology Department
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 28일
기본 완료 (추정된)
2028년 8월 1일
연구 완료 (추정된)
2029년 8월 1일
연구 등록 날짜
최초 제출
2026년 4월 29일
QC 기준을 충족하는 최초 제출
2026년 4월 29일
처음 게시됨 (실제)
2026년 5월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 4일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Pro00119656
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .