Dietary Impact on Sleep, Rhythms and Related Physiology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-32
SponsorUppsala University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Low-fat dietary intervention
Other interventionLow-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).
High-fat dietary intervention
Other interventionHigh-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).
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Healthy dietExperimental treatment 1 intervention
Group B: Unhealthier dietExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sleep Architecture and Neurophysiological Features
Objective registration and analysis of sleep, based on polysomnography or validated wearable devices to capture macrosleep, spectral and microsleep features.
Time frame
Up to 9 nights on each diet2
Change in 24-Hour Heart Rate Variability (HRV)
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.
Time frame
Up to 9 days on each dietSecondary outcomes
1
24-Hour Heart Rate (HR)
Continuous measurement of heart rate using a wearable device
Time frame
Up to 9 days on each diet2
Heart Rate Response to Standardized Stair Stepping
ECG-based heart rate measured at baseline, during stepping and repeatedly (up to 5 min) post-stair stepping, to assess recovery, also analyzed in relation to sleep metrics.
Time frame
Baseline and day 7-9 of each diet period3
Morning-to-Evening and 24-h blood pressure (BP)
Morning, evening, and 24-h ambulatory measurement of systolic blood pressure, also analyzed in relation to sleep metrics.
Time frame
Up to 9 days on each diet4
24 Hour Continuous Glucose Levels
Continuous (24-h) monitoring of interstitial glucose for analysis of mean levels and variability metrics (e.g., SD, coefficient of variation, postprandial changes), also analyzed in relation to sleep metrics.
Time frame
Up to 9 days on each dietSponsors and contacts
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Source ClinicalTrials.gov