Dietary Impact on Sleep, Rhythms and Related Physiology

Официальное название

Inverkan av Kost pa Dygnsrytmer Och Amnesomsattning

Обзор

Sleep and metabolism are closely interconnected, and emerging evidence suggests that dietary composition may influence both sleep quality and key physiological functions such as glucose regulation, cardiovascular activity, and hormonal signaling. This study aims to investigate how a Western-style unhealthy diet versus a healthier, fiber-rich diet affects objective and subjective sleep measures, 24-hour physiological parameters, and a range of biomarkers related to cardiometabolic, neurodegenerative, and gut microbial function.

Подробное описание

Metabolism is tightly regulated by sleep and interacts bidirectionally with diet. While it is well established that insufficient or disrupted sleep can impair glucose regulation, cardiovascular function, and promote unhealthy eating behaviors that promote cardiometabolic disease, less is known about how different dietary patterns impact subjective and objective sleep parameters, as well as related physiological systems.

The study will systematically investigate how consumption of an unhealthier "Western" diet, compared to a healthier diet, affects both objective and subjective sleep parameters, as well as 24-hour heart rate and blood pressure profiles, glucose variability, and hormonal and molecular biomarkers.

The study will be conducted as a 2-condition, randomized crossover study, with assessments in the field for about a week, followed by a multi-day stay for measurements under standardized laboratory conditions. Participants will be monitored using polysomnography, and wearable devices, including for continuous glucose and heart rate parameters, with multi-compartment sampling to assess diet-mediated responses across cardiometabolic, neurodegenerative, and microbial pathways. In field and in the lab, biological samples will be collected repeatedly across the day to establish diurnal rhythms.

Cognitive performance, mood, and subjective appetite will also be evaluated. By identifying diet-driven changes in sleep and related physiological functions, this study aims to provide mechanistic insights into how nutrition impacts sleep, cardiometabolic health parameters and molecular pathways.

Вмешательства

• Другое Low-fat dietary intervention
  Low-fat diet for approximately 1 week, preceding in-lab study period (approximately 2 days) under standardized conditions (total dietary exposure up to 9-10 days).
• Другое High-fat dietary intervention
  High-fat diet for approximately 1 week, preceding in-lab study period (approximately 2 days) under standardized conditions (total dietary exposure up to 9-10 days).

Первичные конечные точки

• Sleep Architecture and Neurophysiological Features [Срок оценки: Up to 9 nights on each diet]
• Change in 24-Hour Heart Rate Variability (HRV) [Срок оценки: Up to 9 days on each diet]

Вторичные конечные точки (12)

• 24-Hour Heart Rate (HR) [Срок оценки: Up to 9 days on each diet]
• Heart Rate Response to Standardized Stair Stepping [Срок оценки: Baseline and day 7-9 of each diet period]
• Morning-to-Evening and 24-h blood pressure (BP) [Срок оценки: Up to 9 days on each diet]
• 24 Hour Continuous Glucose Levels [Срок оценки: Up to 9 days on each diet]
• Levels of Blood-based Biomarkers [Срок оценки: Up to 9 days on each diet]
• Levels of CNS biomarkers [Срок оценки: Up to 9 days on each diet]
• Urinary Metabolite Levels [Срок оценки: Up to 9 days on each diet]
• Change in Metabolic Fuel Utilization [Срок оценки: Up to 9 days on each diet]
• Levels of Fecal Metabolites [Срок оценки: Up to 9 days on each diet]
• Levels of Fecal Microbiota [Срок оценки: Up to 9 days on each diet]
• Levels of Salival Biomarkers [Срок оценки: Up to 9 days on each diet]
• Levels of Salival Microbiota [Срок оценки: Up to 9 days on each diet]

Критерии участия

Критерии включения

• Age 18-32 yr
• Healthy (self-reported) and not on chronic medication
• BMI 18-27 kg/m2 (and waist circumference <102 cm), and weight stable (less than 5% body weight change in the past 6 months)
• Non-smoker and non-nicotine user
• Regular sleep-wake pattern, with sleep duration of 7-9.25 hrs per night
• Regular exercise habits the last 2 months
• Regular daily meal pattern with 3 main meals

Критерии исключения

• Major or chronic illness, e.g. diabetes, renal disease or inflammatory bowel disease
• Current or history of endocrine or metabolic disorders
• Psychiatric or neurological disorders (e.g. bipolar disorder, epilepsy)
• Frequent gastrointestinal symptoms
• Chronic medication
• Any sleep disorder (including recent or chronic symptoms of insomnia)
• Shift work in the preceding three months or for a long duration
• Extreme chronotype or physical activity patterns
• Time travel over two time zones in the preceding month
• Too much weight gain or weight loss in the preceding 6 months (±5% body weight in past 6 months)
• Any issues with or allergies against the provided food items
• Recent major dietary changes or adoption of specific dietary regimens
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study period.
• Use of illicit drugs or substances of abuse

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

Швеция · 1 центр

• Uppsala biomedical center — Uppsala

Идентификаторы

NCT: NCT07138313 · CircHFJC2017pt2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗