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NCT Number: NCT07138313

Dietary Impact on Sleep, Rhythms and Related Physiology

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.

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Key information

Age range

18 year–32 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala biomedical center

Uppsala, 75324, Sweden

Location status: Recruiting

Location contact

Jonathan Cedernaes, MD PhD

CONTACT

[email protected]

004618-617 32 93

Jonathan Cedernaes, MD PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Low-fat dietary intervention

Other

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).

High-fat dietary intervention

Other

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).

Primary outcomes

  1. Sleep Architecture and Neurophysiological Features

    Time frame: 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.

  2. Change in 24-Hour Heart Rate Variability (HRV)

    Time frame: 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.

Secondary outcomes

  1. 24-Hour Heart Rate (HR)

    Time frame: Up to 9 days on each diet

    Continuous measurement of heart rate using a wearable device

  2. Heart Rate Response to Standardized Stair Stepping

    Time frame: Baseline and day 7-9 of each diet period

    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.

  3. Morning-to-Evening and 24-h blood pressure (BP)

    Time frame: Up to 9 days on each diet

    Morning, evening, and 24-h ambulatory measurement of systolic blood pressure, also analyzed in relation to sleep metrics.

  4. 24 Hour Continuous Glucose Levels

    Time frame: Up to 9 days on each diet

    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.

  5. Levels of Blood-based Biomarkers

    Time frame: Up to 9 days on each diet

    Changes in levels of molecular factors such as DNA, hormones/proteins and metabolites, due to the preceding dietary intervention, and also in relation to sleep metrics.

  6. Levels of CNS biomarkers

    Time frame: Up to 9 days on each diet

    Levels of CNS health biomarkers (such as brain-derived neurotrophic factor (BDNF), Tau (e.g. BD-tau) and Amyloid beta (Aβ) species, glial fibrillary acidic protein (GFAP), and Neurofilament light chain (NfL)).

  7. Urinary Metabolite Levels

    Time frame: Up to 9 days on each diet

    Urine levels of excretion molecules (such as melatonin breakdown metabolites).

  8. Change in Metabolic Fuel Utilization

    Time frame: Up to 9 days on each diet

    Change in metabolic fuel utilization as measured by respirometry, in response to the dietary interventions.

  9. Levels of Fecal Metabolites

    Time frame: Up to 9 days on each diet

    Changes in levels of fecal metabolites (such as short chain fatty acids, bile acids) due to each dietary intervention

  10. Levels of Fecal Microbiota

    Time frame: Up to 9 days on each diet

    Changes in fecal microbiota (metagenomic, compositional) due to each dietary intervention

  11. Levels of Salival Biomarkers

    Time frame: Up to 9 days on each diet

    Changes in levels of salival molecules (such as cortisol and melatonin), also in relation to sleep-circadian metrics.

  12. Levels of Salival Microbiota

    Time frame: Up to 9 days on each diet

    Changes in salival microbiota (metagenomic, compositional) due to each dietary intervention

  13. Changes in glucose tolerance

    Time frame: Day 8-9 on each diet

    Glucometabolic response to a standardized 2-h glucose tolerance test, also analyzed in relation to sleep-circadian metrics.

  14. Levels of Immune Cells

    Time frame: Up to 9 days on each diet

    Immune cell profile across the day in response to each diet

  15. Change in Subjective Sleep Quality

    Time frame: Up to 9 days on each diet

    Change in self-reported sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI), supplementing objective sleep data. Total Score (0-21; higher = worse).

  16. Subjective Hunger and Appetite Levels

    Time frame: Up to 9 days on each diet

    Self-reported hunger and appetite across the day, and prior to and after meals, as assessed via visual analogue scales (VAS, i.e., with scores 0 for the lowest subjective rating, to 100 for the highest rating)

  17. Body Temperature

    Time frame: Up to 9 days on each diet

    Body temperature measured via wearable sensors to assess effects of dietary interventions on thermoregulation and its relationship to sleep, circadian rhythms and metabolism.

  18. Change in Composite Cognitive Performance Score

    Time frame: Up to 9 days on each diet

    Composite score from four tasks:

    • Psychomotor Vigilance Task (PVT) - sustained attention; faster reaction times and fewer lapses corresponds to better performance;
    • Go/No-Go Task - inhibitory control; higher accuracy on no-go trials and faster correct go responses corresponds to better performance;
    • Task-Switching Task - cognitive flexibility; smaller switch cost (difference in reaction time between switch and repeat trials) and higher accuracy corresponds to better performance;
    • Memorability Task - episodic memory; higher hit rate (0-100%) and fewer false alarms corresponds to better performance.

    All scores will be standardized and averaged; higher composite values indicate better cognitive performance.

  19. Changes in mental wellbeing

    Time frame: Up to 9 days on each diet

    Self-reported assessment of mental wellbeing using validated subjective scales (visual analogue scales going from lowest 0 to highest of 100), to evaluate effects of diet and sleep.

  20. Changes in Central Hemodynamics

    Time frame: Up to 9 days on each diet

    Morning, evening, and 24-h ambulatory levels of central hemodynamics reflecting central blood pressure and arterial resistance, also analyzed in relation to sleep metrics

  21. Effect Modification by Biological Sex

    Time frame: Based on data collected up to 9 days on each diet

    Exploratory subgroup analysis to determine if male vs. female participants differ in response to dietary interventions, for primary and secondary outcomes

  22. Effect Modification by Cardiorespiratory Fitness

    Time frame: Based on data collected up to 9 days on each diet

    Exploratory analysis to determine whether cardiorespiratory fitness parameters modulates responses to how the diets impact primary and secondary outcomes.

  23. Change in Dim Light Melatonin Onset

    Time frame: Up to 9 days on each diet

    Dim Light Melatonin Onset as assessed via repeatedly measured melatonin levels, measured in the evening under standardized conditions

  24. Levels of molecular biomarkers in dried blood spots

    Time frame: Up to 9 days on each diet

    Analysis of levels of molecular biomarkers (such as CRP) in dried blood spots from finger samples, and how these correlate with biomarker levels from peripheral venous blood samples

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Cedernaes, MD, PhD

CONTACT

[email protected]

0184710000

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

Inverkan av Kost pa Dygnsrytmer Och Amnesomsattning

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 22, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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