Inverkan av Kost pa Dygnsrytmer Och Amnesomsattning
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Sleep Architecture and Neurophysiological Features
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
In the crossover condition, participants will not be briefed about what diet they will receive before the actual onset of any of the two dietary interventions
入排标准
- 年龄范围
- 18 Years 至 32 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Healthy diet
'Low-fat dietary intervention' to be administered to participants
干预措施: Low-fat dietary intervention (Other)
Unhealthier diet
'High-fat dietary intervention' to be administered to participants
干预措施: High-fat dietary intervention (Other)
结局指标
主要结局
Sleep Architecture and Neurophysiological Features
时间窗: Up to 9 nights on each diet
Objective registration and analysis of sleep, based on polysomnography or validated wearable devices to capture macrosleep, spectral and microsleep features.
Change in 24-Hour Heart Rate Variability (HRV)
时间窗: Up to 9 days on each diet
Continuous measurement of HRV, using a wearable device, focused on the metric Root Mean Square of the Successive Differences (RMSD); additional metrics (Standard Deviation of NN intervals (SDNN), low frequency to high frequency (LF/HF) ratio) analyzed for exploratory purposes.
次要结局
- Levels of CNS biomarkers(Up to 9 days on each diet)
- Urinary Metabolite Levels(Up to 9 days on each diet)
- Levels of Fecal Microbiota(Up to 9 days on each diet)
- Changes in glucose tolerance(Day 8-9 on each diet)
- 24-Hour Heart Rate (HR)(Up to 9 days on each diet)
- 24 Hour Continuous Glucose Levels(Up to 9 days on each diet)
- Heart Rate Response to Standardized Stair Stepping(Baseline and day 7-9 of each diet period)
- Levels of Blood-based Biomarkers(Up to 9 days on each diet)
- Levels of Salival Biomarkers(Up to 9 days on each diet)
- Levels of Salival Microbiota(Up to 9 days on each diet)
- Levels of Immune Cells(Up to 9 days on each diet)
- Morning-to-Evening and 24-h blood pressure (BP)(Up to 9 days on each diet)
- Change in Metabolic Fuel Utilization(Up to 9 days on each diet)
- Levels of Fecal Metabolites(Up to 9 days on each diet)
- Change in Subjective Sleep Quality(Up to 9 days on each diet)
- Subjective Hunger and Appetite Levels(Up to 9 days on each diet)
- Body Temperature(Up to 9 days on each diet)
- Change in Composite Cognitive Performance Score(Up to 9 days on each diet)
- Changes in mental wellbeing(Up to 9 days on each diet)
- Changes in Central Hemodynamics(Up to 9 days on each diet)
- Effect Modification by Biological Sex(Based on data collected up to 9 days on each diet)
- Effect Modification by Cardiorespiratory Fitness(Based on data collected up to 9 days on each diet)
- Change in Dim Light Melatonin Onset(Up to 9 days on each diet)
- Levels of molecular biomarkers in dried blood spots(Up to 9 days on each diet)