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Biorhythms in Metabolic Tissues

NCT ID: NCT03276442

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Deprivation Metabolic Disturbance Biological Clocks Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will be studied in a crossover design both after a "healthy diet", and after an "unhealthy diet"
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

In the crossover subgroup condition, participants will not be briefed about what diet they will receive before the actual onset of the dietary intervention

Study Groups

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Healthy diet

'Low-fat dietary intervention' to be administered to participants

Group Type EXPERIMENTAL

Low-fat dietary intervention

Intervention Type OTHER

Low-fat diet (5-7 days) preceding extended wakefulness under standardized conditions

Unhealthy diet

'High-fat dietary intervention' to be administered to participants

Group Type EXPERIMENTAL

High-fat dietary intervention

Intervention Type OTHER

High-fat diet (5-7 days) preceding extended wakefulness under standardized conditions

Interventions

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Low-fat dietary intervention

Low-fat diet (5-7 days) preceding extended wakefulness under standardized conditions

Intervention Type OTHER

High-fat dietary intervention

High-fat diet (5-7 days) preceding extended wakefulness under standardized conditions

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

32 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Cedernaes

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

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Department of Neuroscience, Uppsala University

Uppsala, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Jonathan Cedernaes, M.D., Ph.D.

Role: CONTACT

Phone: 0184714136

Email: [email protected]

Christian Benedict, Ph.D.

Role: CONTACT

Phone: 0184714136

Email: [email protected]

Facility Contacts

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Jonathan Cedernaes, MD, PhD

Role: primary

Christian Benedict, PhD

Role: backup

References

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Brandao LEM, Popa A, Cedernaes E, Cedernaes C, Lampola L, Cedernaes J. Exposure to a more unhealthy diet impacts sleep microstructure during normal sleep and recovery sleep: A randomized trial. Obesity (Silver Spring). 2023 Jul;31(7):1755-1766. doi: 10.1002/oby.23787. Epub 2023 May 28.

Reference Type DERIVED
PMID: 37245331 (View on PubMed)

Other Identifiers

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CircHFJC2017

Identifier Type: -

Identifier Source: org_study_id