Stress and Menstrual Health

Официальное название

The Influence of Non-energetic Stressors on Human Menstrual Function

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Heat stress
  Stress-Heat participants will undergo supervised 40-min sessions in a 70-80˚C sauna
• Другое 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.
• Другое 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.

Первичные конечные точки

• Total daily energy expenditure (TDEE) [Срок оценки: Baseline (Month 2), Intervention (Month 4)]
• Basal metabolic rate (BMR) [Срок оценки: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)]
• Sex hormone concentration (estradiol) [Срок оценки: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)]
• Sex hormone concentration (progesterone) [Срок оценки: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)]

Вторичные конечные точки (5)

• Stress hormone concentration (norepinephrine) [Срок оценки: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)]
• Stress hormone concentration (cortisol) [Срок оценки: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)]
• Stress hormone concentration (salivary alpha-amylase) [Срок оценки: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)]
• Sex hormone concentration (luteinizing hormone (LH)) [Срок оценки: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)]
• Sex hormone concentration (follicle-stimulating hormone (FSH)) [Срок оценки: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)]

Критерии участия

Критерии включения

• Adult pre-menopausal females, 18-45 years old
• Habitually sedentary (less than 60 minutes MVPA/week) for Exercise cohort

Критерии исключения

• 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 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Duke University — Durham

Идентификаторы

NCT: NCT07566260 · Pro00119656

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗