Меню
Идёт набор NCT07084675

Dehydration, Rehydration, and Impact on Physiology

Без фазы С лечением Aging

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Hydration-Dehydration-Rehydration Protocol (HDR).
Кому может быть актуально
Состояния в реестре: Aging. Базовые параметры: 45 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Impact of Mild Dehydration and Subsequent Rehydration on Cellular Stress and Physiological Performance

Обзор

Our goal is to determine whether hydration status influences inflammation, and overall physiological performance in adults aged 45-65. Aim 1: The effects of 4-day mild dehydration followed by 4-day rehydration (defined as approximately 2-3% body mass loss) on H2O2, upstream inflammatory signal (NFkB), mitochondrial fragmentation, and autophagy in circulating PBMCs. Aim 2: The effects of 4-day mild dehydration followed by 4-day rehydration (defined as approximately 2-3% body mass loss) on fasting glucose, sleep performance, and strength performance. Participant will: complete a 4-day hydration protocol, followed by a 4-day dehydration protocol, and then a 4-day rehydration protocol. attend five laboratory visits for testing: Day 1: Informed consent and familiarization Day 2: Pre-hydration testing (before the 4-day hydration protocol) Day 3: Pre-dehydration testing (before the dehyration protocol) Day 4: Post-dehydration testing (after the dehydration protocol) Day 5: Post-rehydration testing (after the rehydration protocol)

Вмешательства

  • Поведенческое Hydration-Dehydration-Rehydration Protocol (HDR)
    The HDR Protocol is a 12-day, sequential fluid manipulation intervention designed to assess the physiological effects of controlled changes in hydration status. The protocol consists of three consecutive 4-day phases: Hydration Phase (Days 1-4): Participants follow a standardized fluid intake protocol designed to promote and maintain a euhydrated state. Hydration status is monitored using objective measures such as urine specific gravity and body mass. Dehydration Phase (Days 5-8): Participant

Первичные конечные точки

  • Fasting blood glucose (mg/dL) [Срок оценки: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)]
  • Total body water (L) [Срок оценки: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)]
  • Intracellular water (L) [Срок оценки: Time Frame: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)]
  • Extracellular water (L) [Срок оценки: Time Frame: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)]
  • Hand grip strength (kg) [Срок оценки: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)]
  • Isometric leg pull strength (kg) [Срок оценки: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)]
  • Total sleep time (hrs) [Срок оценки: through study completion, 18 days]
  • Sleep efficiency (%) [Срок оценки: through study completion, 18 days]
  • Number of awakenings (count) [Срок оценки: through study completion, 18 days]
  • PBMC H2O2 ( µg/mL) [Срок оценки: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)]
Вторичные конечные точки (3)
  • Change in hydration status via urine specific gravity (USG) [Срок оценки: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)]
  • Total lean mass (g) [Срок оценки: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)]
  • Total fat mass (g) [Срок оценки: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)]

Критерии участия

Критерии включения

  • Apparently Healthy
  • BMI < 30 kg/m2
  • Body weight is at least 110 lbs

Критерии исключения

  • Currently pregnant
  • Have Type 1 Diabetes or Type 2 Diabetes
  • Have chronic kidney disease or a history of kidney stones
  • Have hypertension
  • Take medications that can cause fluid retention, such as corticosteroids, chronic use of Nonsteroidal Anti-inflammatory Drugs (NSAIDs), Hormonal Therapies (e.g., estrogen, androgens or anabolic steroids), Antihypertensives, Psychiatric Medications (e.g., Lithium), Vasodilators
  • Take medications that reduce fluid retention: diuretics, and RAAS Inhibitors (e.g., ACE inhibitors and ARBs)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Texas Tech University — Lubbock

Идентификаторы

NCT: NCT07084675 · IRB2025-288

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗