Sleep DeprivationNCT03276442
Biorhythms in Metabolic Tissues
A study testing Low-fat dietary intervention and High-fat dietary intervention in people with Sleep Deprivation and Metabolic Disturbance, run by Uppsala University at 1 site in Sweden.
Trial 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"). Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Metabolic Disturbance, Biological Clocks
- What is being tested?
- Low-fat dietary intervention and High-fat dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 31 Aug 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Neuroscience, Uppsala University
Uppsala, 75324
Jonathan Cedernaes, MD, PhD, +46184714102, jonathan.cedernaes@neuro.uu.se
Christian Benedict, PhD, 46184714136, christian.benedict@neuro.uu.se
About this study
Official title: Biological Rhythms in Metabolic Tissues: Impact of Diet
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.
- Conditions
- Sleep Deprivation, Metabolic Disturbance, Biological Clocks, Healthy
- Being tested
- Low-fat dietary intervention, High-fat dietary intervention
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-fat dietary interventionOther
Low-fat diet (5-7 days) preceding extended wakefulness under standardized conditions
High-fat dietary interventionOther
High-fat diet (5-7 days) preceding extended wakefulness under standardized conditions
| Study group | Role | What they receive |
|---|---|---|
| Healthy diet | Experimental | 'Low-fat dietary intervention' to be administered to participants Receives: Other: Low-fat dietary intervention |
| Unhealthy diet | Experimental | 'High-fat dietary intervention' to be administered to participants Receives: Other: High-fat dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in clock gene & associated omic circadian rhythms
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
Measured: 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)
Secondary outcomes (8)
Wakefulness-induced changes and subsequent recovery at omic levels
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
Measured: 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
24-h rhythms in blood
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
Measured: 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)
Diet-induced changes in gut microbiota and relation to circadian rhythms
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
Measured: Measured throughout study participation, i.e. on average over 6-7 weeks
Energy expenditure rhythms
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
Measured: 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)
Urine metabolite rhythms
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
Measured: Measured throughout study participation, i.e. on average over 6-7 weeks
Rhythms of blood markers of damage to the central nervous system
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
Measured: 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)
24-h rhythms in saliva
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
Measured: 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)
Central circadian rhythms
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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start31 Aug 2017
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be studied in a crossover design both after a "healthy diet", and after an "unhealthy diet"
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Sponsor
- Investigators
- Jonathan Cedernaes, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276442
- Sponsor's protocol ID
- CircHFJC2017
- Status last verified
- Oct 2017
- First submitted
- 28 Aug 2017
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37245331
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Rhythms in Metabolic Tissues: Impact of Diet
- ClinicalTrials.gov ID
- NCT03276442
- Acronym / sponsor ID
- CircHFJC2017
- Conditions
- Sleep Deprivation, Metabolic Disturbance, Biological Clocks, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be studied in a crossover design both after a "healthy diet", and after an "unhealthy diet"
| Arm | Type | Receives |
|---|---|---|
| Healthy diet | Experimental | Other: Low-fat dietary intervention'Low-fat dietary intervention' to be administered to participants |
| Unhealthy diet | Experimental | Other: High-fat dietary intervention'High-fat dietary intervention' to be administered to participants |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-fat dietary interventionLow-fat diet (5-7 days) preceding extended wakefulness under standardized conditions | Other | Healthy diet |
| High-fat dietary interventionHigh-fat diet (5-7 days) preceding extended wakefulness under standardized conditions | Other | Unhealthy diet |
Primary outcome
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
8 secondary outcomes
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
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)
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
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)
Urine metabolite rhythms
Time frame: Measured throughout study participation, i.e. on average over 6-7 weeks
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Derived from this study: PubMed 37245331Brandao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Cedernaes principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-fat dietary intervention and High-fat dietary intervention in people with Sleep Deprivation and Metabolic Disturbance, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Cedernaes, M.D., Ph.D. (0184714136, jonathan.cedernaes@neuro.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03276442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017; AzTrials last refreshed its copy on 27 Oct 2026.