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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
600
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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North Carolina
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Durham、North Carolina、アメリカ、27708
- 募集
- Duke University
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コンタクト：
- Mary Joy
- 電話番号：7249317802
- メール：mary.joy@duke.edu
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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).
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Stress-Heat participants will undergo supervised 40-min sessions in a 70-80˚C sauna
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実験的：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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実験的：Exercise Stress
One-hour cycling at 60-75% predicted max HR for 5 consecutive days (days 4-8 or 5-9 of follicular phase).
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Basal metabolic rate (BMR)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Stress hormone concentration (norepinephrine)
時間枠：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)
時間枠：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)
時間枠：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))
時間枠：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))
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Herman Pontzer, PhD、Duke University Evolutionary Anthropology Department
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月28日
一次修了 (推定)
2028年8月1日
研究の完了 (推定)
2029年8月1日
試験登録日
最初に提出
2026年4月29日
QC基準を満たした最初の提出物
2026年4月29日
最初の投稿 (実際)
2026年5月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月9日
QC基準を満たした最後の更新が送信されました
2026年9月4日
最終確認日
2026年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。