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Набор скоро начнётся NCT07393607

Effects of Acute Sleep Deprivation on Human Behaviours

Без фазы С лечением Physical Activity Energy Intake Appetite Food Choice

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: Normal sleep, Partial sleep deprivation.
Кому может быть актуально
Состояния в реестре: Physical Activity, Energy Intake, Appetite, Food Choice. Базовые параметры: 20 лет — 45 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Acute Effects of Partial Sleep Deprivation on Appetite, Energy Intake and Physical Activity

Обзор

This study will investigate whether acute sleep deprivation affects appetite, eating behavior, and physical activity in both regular exercisers and physically inactive individuals.

Подробное описание

Prior to the main trials, participants will complete assessments of V̇O2max and maximal muscle strength within 7 to 14 days before the main trials. They will also record one week of daily physical activity, sleep patterns, and diet (including two weekdays and one weekend day) to ensure they meet the inclusion criteria.

Participants will be healthy males aged 20 to 45, grouped according to their habitual activity levels.

1. Sedentary: fewer than 7,000 steps/day, no regular exercise in the past 6 months. 2. Regular Aerobic Exercise: Running or cycling at least 2-3 times/week for the past 6 months. 3. Regular Resistance Exercise: Engaging in resistance exercise at least 2-3 times/week for the past 6 months, with minimal aerobic training.

Day 1:

Physical activity is restricted to a minimum, with no exercise permitted. Participants are allowed to eat freely before 15:00; however, all food intake will be recorded to enable replication prior to the subsequent main trial. Napping is not permitted. Participants will arrive at the laboratory between 18:30 and 19:00. Subjective appetite sensations and food preferences will be assessed. Participants will have either an 8-hour sleep opportunity in the laboratory from 23:00 to 07:00 (i.e., normal sleep trial) or a 3-hour sleep opportunity from 03:00 to 07:00 (i.e., partial sleep deprivation trial).

Day 2:

Participants will wake at 07:00. After completing personal hygiene, they will rest for 20 minutes to ensure full alertness. At 07:30, a 20-minute resting metabolic rate assessment will be conducted, alongside the collection of heart rate variability and muscle oxygen saturation data. Subsequently, pulse wave velocity measurement, cognitive function tests, subjective questionnaires, and a computerized food preference test will be administered.

After the baseline assessment, a 3-hour oral glucose tolerance test (OGTT) will be administered. Visual analogue scale assessments-including sleep, appetite, and mood-will be conducted every 30 minutes during the OGTT. Food preferences will be measured 180 minutes after the completion of the OGTT. Upon leaving the laboratory, participants will be provided with a pedometer and wearable devices and instructed to record dietary intake (using a food scale and photographic records), sleep, and glucose values on the experimental day and for the following four consecutive days.

Вмешательства

  • Поведенческое Normal sleep
    Participants will have an 8-hour sleep opportunity in the lab from 23:00 to 07:00.
  • Поведенческое Partial sleep deprivation
    Participants will have a 3-hour sleep opportunity in the lab from 03:00 to 07:00.

Первичные конечные точки

  • Energy intake [Срок оценки: 4 days in a free-living conditions.]
  • Physical activity [Срок оценки: 4 days in a free-living conditions.]
Вторичные конечные точки (6)
  • Food preference [Срок оценки: Baseline and at the end of the 3-hour oral glucose tolerance test (OGTT).]
  • Appetite sensations [Срок оценки: At 0 (baseline), 30, 60, 90, 120, 150, and 180 minutes during the 3-hour oral glucose tolerance test (OGTT).]
  • Mood sensations [Срок оценки: At 0 (baseline), 30, 60, 90, 120, 150, and 180 minutes during the 3-hour oral glucose tolerance test (OGTT).]
  • Sleep sensations [Срок оценки: At 0 (baseline), 30, 60, 90, 120, 150, and 180 minutes during the 3-hour oral glucose tolerance test (OGTT).]
  • Sleep [Срок оценки: 4 days in a free-living conditions.]
  • Glucose responses [Срок оценки: 4 days in a free-living conditions.]

Критерии участия

Критерии включения

  • Age between 20 and 45 years.
  • Body Mass Index (BMI) between 18.5 to 27 kg/m².
  • No sleep-related medical conditions and good sleep quality, defined as a Pittsburgh Sleep Quality Index (PSQI) score ≤ 5.
  • Usual bedtime between 22:00 and 01:00, wake-up time between 06:00 and 09:00, with an average sleep duration of 7 to 9 hours. Chronotype classified as "definitely not evening type" (score ≥ 42 on the Morningness-Eveningness Questionnaire), with no changes in sleep patterns over the past 3 months.
  • Without any metabolic or cardiovascular diseases, and not using medications that could affect metabolic responses.
  • No specific dietary habits, such as intermittent fasting or a ketogenic diet.
  • Maintaining a stable weight (no self-reported weight change greater than ±3 kg) for at least 3 months.
  • Resting blood pressure ≤ 130/80 mmHg.
  • No smoking or excessive alcohol consumption.
  • Not a shift worker.
  • No international travel across time zones in the past 3 months.

Критерии исключения

  • Special diets (e.g., intermittent fasting, ketogenic diet)
  • Recent injuries or contraindications to intense exercise.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07393607 · 202412HM033-2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗