Nighttime Synchrony of Your Nutrition and Circadian Health

Официальное название

Nighttime Synchrony of Your Nutrition and Circadian Health: The N-Sync Study

Обзор

Sleep is an important factor for overall health. This study will see how different light exposure patterns and food intake impact a person's metabolism (how the body breaks down food) when sleeping is reduced. Participants will attend 6 to 8 in-person visits to the study clinic, including three overnight stays. People will complete surveys and medical tests. The study will last about 4 to 6 months.

Подробное описание

This study is a randomized in-lab, cross-over trial. Each participant will complete all three arms in either condition order #1 (A-B-C) or order #2 (A-C-B). Each arm will consist of 5 nights of experimental sleep restriction followed by a constant routine protocol for assessment of 24-h rhythms. Sleep restriction in the three arms will occur under the following conditions: (A-control condition) Sleep Restriction with Central and Peripheral Alignment; (B) Sleep Restriction with Central Clock Misalignment; and (C) Sleep Restriction with Peripheral Misalignment. Prior to enrollment participants will complete a comprehensive medical history and clinical overnight sleep disorders screening. Baseline consists of a \~2-week ambulatory real-world monitoring segment that will occur immediately prior to each in-lab sleep restriction condition. Following the 5 days of sleep restriction in each arm, participants will complete an intravenous glucose tolerance test to analyze insulin sensitivity, prior to completing the constant routine.

Вмешательства

• Поведенческое Central Clock Misalignment
  Light exposure will be dimmed during the first 4 hours of scheduled wakefulness, with bright light exposure during the nighttime hours of extended wakefulness.
• Поведенческое Peripheral Misalignment
  Most daily calories will be given later in the day to shift eating patterns toward the nighttime hours.

Первичные конечные точки

• Insulin Sensitivity [Срок оценки: Immediately following the 5-day sleep restriction segment]
• Internal Circadian Misalignment (Uridine and Isobutyryl-L-carnitine) [Срок оценки: During the constant routine, following the 5-day sleep restriction segment]

Критерии участия

Критерии включения

• Age: 18-35 years old; equal numbers of men and women
• Body Mass Index (BMI): 18.5-24.9 kg/m2
• Sleep Habits: habitual self-reported average total sleep time (TST) 7-9 hours per night for prior 6 months

Критерии исключения

• Clinically diagnosed sleep disorder or apnea hypopnea index (AHI) ≥5
• Evidence of significant organ system dysfunction or disease (e.g., heart disease, diabetes)
• Fasting plasma glucose ≥100 mg/dL
• Major psychiatric illness (e.g., major depressive disorder)
• Cancer that has been in remission less than 5 years
• History of shift-work in prior year
• Weight change >5% of body weight over prior six months
• Currently following a weight-loss program
• Menopause
• Pregnant/nursing
• Greater than 5-day variation in menstrual cycle length month-to-month
• Currently smoking
• Alcohol intake >14 drinks/week or >3 drinks/day.
• Use of prescription medications (except oral contraceptives) within one month prior to or during in-lab visits.
• Consumption of illegal drugs or >500mg per day of caffeine.

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

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• College of Health Research Complex - University of Utah, Salt Lake City 84112 — Salt Lake City

Идентификаторы

NCT: NCT07329283 · 185590

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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