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Trial record 2 of 72 for:    "The Swedish Research Council" [Exact]

Biorhythms in Metabolic Tissues

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ClinicalTrials.gov Identifier: NCT03276442
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : October 12, 2017
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Uppsala University

Brief Summary:
Metabolism is increasingly recognized as being highly regulated by anticipatory biological rhythms (circadian rhythms or "biorhythms"), which are driven by molecular feedback loops, and which are approximately 24 hours long ("circa diem"). These circadian rhythms exist both centrally, in the brain, but also in the periphery, and are specific to many tissues depending on their main biological function or functions. Whereas these circadian rhythms have been thoroughly characterized in other organisms, their role in humans remain poorly understood, partly because of the difficulty in studying these rhythms in peripheral tissues. The investigators therefore aim to characterize these rhythms in primarily skeletal muscle and adipose tissue in healthy young volunteers (using the so-called constant routine paradigm), and how these rhythms interact with one another at various genetic and molecular levels. At the same time, the investigators aim to study how an unhealthy vs. healthy diet can alter these circadian rhythms, and how they interact with circadian rhythms in other tissue compartments such as those expressed by blood cells.

Condition or disease Intervention/treatment Phase
Sleep Deprivation Metabolic Disturbance Biological Clocks Healthy Other: Low-fat dietary intervention Other: High-fat dietary intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will be studied in a crossover design both after a "healthy diet", and after an "unhealthy diet"
Masking: None (Open Label)
Masking Description: In the crossover subgroup condition, participants will not be briefed about what diet they will receive before the actual onset of the dietary intervention
Primary Purpose: Basic Science
Official Title: Biological Rhythms in Metabolic Tissues: Impact of Diet
Actual Study Start Date : August 31, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Healthy diet
'Low-fat dietary intervention' to be administered to participants
Other: Low-fat dietary intervention
Low-fat diet (5-7 days) preceding extended wakefulness under standardized conditions

Experimental: Unhealthy diet
'High-fat dietary intervention' to be administered to participants
Other: High-fat dietary intervention
High-fat diet (5-7 days) preceding extended wakefulness under standardized conditions




Primary Outcome Measures :
  1. Changes in clock gene & associated omic circadian rhythms [ Time Frame: Measured repeatedly (every 6 hours for 24 hours) during a period of extended wakefulness, following each dietary intervention (i.e. over a total period of 6-7 weeks) ]
    Changes in clock gene & associated clock-regulated & clock-independent metabolic and omic circadian rhythms (e.g. in epigenome, transcriptome, metabolites) in peripheral tissues (primarily skeletal muscle and adipose tissue), and interplay between these rhythms across the 24-h period and under the different dietary conditions


Secondary Outcome Measures :
  1. Wakefulness-induced changes and subsequent recovery at omic levels [ Time Frame: Following each dietary intervention (i.e. over a total period of 6-7 weeks), measured repeatedly (every 2-6 hours for 24 hours) during a period of extended wakefulness, and after recovery sleep ]
    Changes at omic levels (e.g. DNA methylation, transcriptome, proteome, metabolome) in peripheral tissues (primarily skeletal muscle and adipose tissue), urine and feces samples due to extended wakefulness following subsequent recovery, following each dietary intervention

  2. 24-h rhythms in blood [ Time Frame: Measured repeatedly (every 2-3 hours over 24 hours) during a period of extended wakefulness and after subsequent recovery, following each dietary intervention (i.e. over a total period of 6-7 weeks) ]
    Changes in rhythms in blood-borne cells, proteins and other molecular factors such as DNA, hormones, and proteins, due to the preceding dietary intervention, and relation to other rhythms measured across 24 hrs following the two dietary conditions

  3. Diet-induced changes in gut microbiota and relation to circadian rhythms [ Time Frame: Measured throughout study participation, i.e. on average over 6-7 weeks ]
    Changes in gut microbiota (metagenomic, compositional) due to dietary intervention, and relation to circadian rhythms measured across 24 hrs in peripheral tissues following the two dietary conditions

  4. Energy expenditure rhythms [ Time Frame: Measured repeatedly (every 2 hours over 24 hours) during a period of extended wakefulness and after subsequent recovery, following each dietary intervention (i.e. over a total period of 6-7 weeks) ]
    Changes in energy expenditure rhythms due to the preceding dietary intervention, and relation to other rhythms measured across 24 hrs following the two dietary conditions

  5. Urine metabolite rhythms [ Time Frame: Measured throughout study participation, i.e. on average over 6-7 weeks ]
    Changes in levels of urine metabolites due to dietary intervention, and relation to circadian rhythms across 24 hrs in peripheral tissues following the two dietary conditions

  6. Rhythms of blood markers of damage to the central nervous system [ Time Frame: Measured repeatedly (every 1-3 hours over 24 hours) during a period of extended wakefulness and after subsequent recovery, following each dietary intervention (i.e. over a total period of 6-7 weeks) ]
    Assessment of rhythms in of blood markers of damage to the central nervous system (e.g. Olink Proseek multiplex panel, neuron-specific enolase, S-100b) across a 24-h period and following subsequent recovery sleep, following the two dietary conditions

  7. 24-h rhythms in saliva [ Time Frame: Measured repeatedly (every 2-3 hours over 24 hours) during a period of extended wakefulness and after subsequent recovery, following each dietary intervention (i.e. over a total period of 6-7 weeks) ]
    Changes in rhythms in saliva-borne cells, proteins and other molecular factors such as DNA, hormones, and proteins, due to the preceding dietary intervention, and relation to other rhythms measured across 24 hrs following the two dietary conditions

  8. Central circadian rhythms [ Time Frame: Measured repeatedly (every 1-3 hours over 24 hours) during a period of extended wakefulness and after subsequent recovery, following each dietary intervention (i.e. over a total period of 6-7 weeks) ]
    Changes in centrally driven circadian rhythms (e.g. temperature and melatonin), due to the preceding dietary intervention, and relation to other rhythms measured across 24 hrs following the two dietary conditions



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Ages Eligible for Study:   18 Years to 32 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-33 yr
  • Healthy (self-reported) and not on medication
  • BMI 18-28 kg/m2 (and waist circumference <102 cm), and weight stable (±5% body weight in past 6 months)
  • Non-smoker and non-nicotine user
  • Regular sleep-wake pattern, with sleep duration of 7-9.25 hrs per night
  • Sedentary to moderately active with 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 (e.g. irregular bedtimes, symptoms of insomnia)
  • Any issues with or allergies against the provided food items or utilized anesthesia
  • Shift work in the preceding three months or for a long duration
  • Time travel over two time zones in the preceding month
  • Too much weight gain or weight loss in the preceding 6 months
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276442


Contacts
Contact: Jonathan Cedernaes, M.D., Ph.D. 0184714136 jonathan.cedernaes@neuro.uu.se
Contact: Christian Benedict, Ph.D. 0184714136 christian.benedict@neuro.uu.se

Locations
Sweden
Department of Neuroscience, Uppsala University Recruiting
Uppsala, Sweden, 75324
Contact: Jonathan Cedernaes, MD, PhD    +46184714102    jonathan.cedernaes@neuro.uu.se   
Contact: Christian Benedict, PhD    46184714136    christian.benedict@neuro.uu.se   
Principal Investigator: Jonathan Cedernaes, MD, PhD         
Sponsors and Collaborators
Uppsala University
The Swedish Research Council
Investigators
Principal Investigator: Jonathan Cedernaes Uppsala University

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT03276442     History of Changes
Other Study ID Numbers: CircHFJC2017
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders