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Stress and Menstrual Health

2026年9月4日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

600

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • North Carolina
      • Durham、North Carolina、美国、27708
        • 招聘中
        • Duke University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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).
其他：Heat stress
Stress-Heat participants will undergo supervised 40-min sessions in a 70-80˚C sauna
实验性的：Sleep Stress
Sleep restriction to 4-6 hours/night for 5 consecutive nights (on days 3-8 or 4-9 of follicular phase).
其他：Sleep stress
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.
实验性的：Exercise Stress
One-hour cycling at 60-75% predicted max HR for 5 consecutive days (days 4-8 or 5-9 of follicular phase).
其他：Exercise stress
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Basal metabolic rate (BMR)
大体时间：Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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)
大体时间：Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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)
大体时间：Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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)
Total daily energy expenditure (TDEE)
大体时间：Control (Month 3), Intervention (Month 4)
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.
Control (Month 3), Intervention (Month 4)

次要结果测量

结果测量
措施说明
大体时间
Stress hormone concentration (norepinephrine)
大体时间：Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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)
Stress hormone concentration (cortisol)
大体时间：Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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)
Stress hormone concentration (salivary alpha-amylase)
大体时间：Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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 (luteinizing hormone (LH))
大体时间：Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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 (follicle-stimulating hormone (FSH))
大体时间：Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Duke University

调查人员

  • 首席研究员：Herman Pontzer, PhD、Duke University Evolutionary Anthropology Department

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月28日

初级完成 (估计的)

2028年8月1日

研究完成 (估计的)

2029年8月1日

研究注册日期

首次提交

2026年4月29日

首先提交符合 QC 标准的

2026年4月29日

首次发布 (实际的)

2026年5月5日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月4日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Pro00119656

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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