SleepNCT02075723
Effect of Sleep Restriction on Metabolic Disturbances Caused by Overfeeding
A study testing Overfeeding (130 % of energy requirements ) and Sleep restriction (4 hours per night) in people with Sleep, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine if sleep restriction provokes an increase in risk factors for metabolic diseases, such as elevation of ectopic fat and decreased sensitivity to insulin. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Overfeeding (130 % of energy requirements ) and Sleep restriction (4 hours per night)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to Dec 2015
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health
- BMI 18.5-25 kg/m2
- Blood pressure at rest less than 140/ 90 mmHg .
- Physical activity level: sedentary or light (< 3 hours of sport per week )
- Lack of sleep pathology ( including sleep apnea and insomnia )
- Regular sleep-wake cycles
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- Average duration of sleep over 7h
- Circadian Typology by Horne \& Ostberg questionnaire ≥ 30 and ≤ 70
- Score questionnaire Pittsburgh Sleep Quality Index ≤ 5
- Screening polysomnography showing sleep efficiency ≥ 85 % and apnea- hypopnea index and periodic leg movements < 15 / h .
Who cannot join
- Current smoking
- Family history of diabetes
- History of sleep disorders
- Circadian Typology by Horne \& Ostberg [ 16-30 ] or [ 70-86 ]
- Score questionnaire Pittsburgh Sleep Quality Inde x> 5
- Polysomnography indicating a sleep efficiency <85% and apnea-hypopnea index and periodic leg movements > 15 / h.
Show all 21Show fewer
- Consumption of more than 3 coffees a day
- Drinking alcool (more than 10g /d)
- Use of Drugs
- Medication
- Night work by shifts
- Average duration of sleep less than 7 hours per night
- Occupational Risks in sleep restriction conditions: e.g. professional drivers
- Special Diet ( vegetarianism, veganism , etc. )
- Change in weight of more than 3 kg in the last 3 months
- Consumption of more than 3 dl sugar-sweetened beverages per day ( sodas, energy drinks , fruit juice , flavored milk sugar )
- Contraindication for magnetic resonance imaging ( pacemaker , previous eye surgery, the presence of metal implant or foreign body, Claustrophobia, etc. )
- For women: pregnancy (current or desired)
- Hemoglobin level < 13.5g/dl for men and < 12.5g/dl for women
- Ferritin level < 50ug / l
- Blood donation in the last 8 weeks
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Center for Investigation and Reseaarch on Sleep and Physiology Department, University Hospital
Lausanne, Canton of Vaud, 1011
Virgile Lecoultre, PhD, 0041 21 692 55 70, virgile.lecoultre@unil.ch
About this study
The purpose of this study is to determine if sleep restriction provokes an increase in risk factors for metabolic diseases, such as elevation of ectopic fat and decreased sensitivity to insulin. We propose to evaluate the effect of sleep restriction in a model of metabolic challenge (overfeeding) caricaturing the conditions of modern societies everyday life .
Read the detailed description
General hypothesis :
In overfeeding condition, the stress response generated by partial sleep restriction of six days will induce an accumulation of fat in the liver and a decreased insulin sensitivity of adipose tissue , liver and muscle, more pronounced that in overfeeding condition only, provoked by a deregulation of the nocturnal lipolysis .
Specific goals :
Purpose 1 : To measure the accumulation of fat in the liver (measured by nuclear magnetic resonance ) and the tissue insulin sensitivity ( measured by a test meal ) in response to a sleep restriction in overfeeding condition .
Hypothesis 1: In overfeeding condition (130 % of energy requirements ) , hepatic lipid accumulation will be higher after 6 days of sleep restriction (4 hours per night) compared to a control condition (8 hours of sleep per night ) . Decreased sensitivity to insulin in the liver, adipose tissue and the associated muscle will be associated at this ectopic fat accumulation.
Purpose 2 : To determine the alteration of lipolysis in response to sleep restriction in overfeeding condition.
Hypothesis 2: In overfeeding condition, sleep restriction will increase the concentrations of circulating fatty acids and glycerol in relation to condition of normal sleep.
- Conditions
- Sleep
- Being tested
- Overfeeding (130 % of energy requirements ), Sleep restriction (4 hours per night)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overfeeding (130 % of energy requirements )Dietary supplement
Overfeeding (130 % of energy requirements )
Sleep restriction (4 hours per night)Behavioural
Sleep restriction (4 hours per night)
| Study group | Role | What they receive |
|---|---|---|
| Overfeeding + sleep restriction | Experimental | overfeeding condition (130 % of energy requirements ) + 6 days of sleep restriction (4 hours per night) Receives: Dietary Supplement: Overfeeding (130 % of energy requirements ); Behavioral: Sleep restriction (4 hours per night) |
| Overfeeding + normal sleep duration | Experimental | overfeeding condition (130 % of energy requirements ) + 6 days of normal sleep duration (8 hours per night) Receives: Dietary Supplement: Overfeeding (130 % of energy requirements ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulation of fat in the liver (measured by nuclear magnetic resonance ) and the tissue insulin sensitivity ( measured by a test meal ) in response to a sleep restriction in overfeeding condition .
Measured: After 6 days of sleep restriction (4 h/day) vs. normal sleep (8 h/day)
Secondary outcomes (1)
Blood concentrations of circulating fatty acids and glycerol
Measured: After 6 days of sleep restriction (4 h/day) vs. normal sleep (8 h/day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (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 SleepStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José HABA-RUBIO, University of Lausanne Hospitals
- Investigators
- José Haba-Rubio, MD, Principal investigator, Center for Investigation and Research on Sleep, University Hospital, Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075723
- Sponsor's protocol ID
- SleepDep 02/14
- Status last verified
- May 2015
- First submitted
- 27 Feb 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cros J, Pianezzi E, Rosset R, Egli L, Schneiter P, Cornette F, Pouymayou B, Heinzer R, Tappy L, Kreis R, Boesch C, Haba-Rubio J, Lecoultre V. Impact of sleep restriction on metabolic outcomes induced by overfeeding: a randomized controlled trial in healthy individuals. Am J Clin Nutr. 2019 Jan 1;109(1):17-28. doi: 10.1093/ajcn/nqy215.
PubMed 30615104
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sleep Restriction on Metabolic Disturbances Caused by Overfeeding
- ClinicalTrials.gov ID
- NCT02075723
- Acronym / sponsor ID
- SleepDep 02/14
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 3 Mar 2014 (estimated)
- 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.
The purpose of this study is to determine if sleep restriction provokes an increase in risk factors for metabolic diseases, such as elevation of ectopic fat and decreased sensitivity to insulin. We propose to evaluate the effect of sleep restriction in a model of metabolic challenge (overfeeding) caricaturing the conditions of modern societies everyday life .
Detailed description
General hypothesis :
In overfeeding condition, the stress response generated by partial sleep restriction of six days will induce an accumulation of fat in the liver and a decreased insulin sensitivity of adipose tissue , liver and muscle, more pronounced that in overfeeding condition only, provoked by a deregulation of the nocturnal lipolysis .
Specific goals :
Purpose 1 : To measure the accumulation of fat in the liver (measured by nuclear magnetic resonance ) and the tissue insulin sensitivity ( measured by a test meal ) in response to a sleep restriction in overfeeding condition .
Hypothesis 1: In overfeeding condition (130 % of energy requirements ) , hepatic lipid accumulation will be higher after 6 days of sleep restriction (4 hours per night) compared to a control condition (8 hours of sleep per night ) . Decreased sensitivity to insulin in the liver, adipose tissue and the associated muscle will be associated at this ectopic fat accumulation.
Purpose 2 : To determine the alteration of lipolysis in response to sleep restriction in overfeeding condition.
Hypothesis 2: In overfeeding condition, sleep restriction will increase the concentrations of circulating fatty acids and glycerol in relation to condition of normal sleep.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overfeeding + sleep restriction | Experimental | Dietary Supplement: Overfeeding (130 % of energy requirements ), Behavioral: Sleep restriction (4 hours per night)overfeeding condition (130 % of energy requirements ) + 6 days of sleep restriction (4 hours per night) |
| Overfeeding + normal sleep duration | Experimental | Dietary Supplement: Overfeeding (130 % of energy requirements )overfeeding condition (130 % of energy requirements ) + 6 days of normal sleep duration (8 hours per night) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Good general health
- BMI 18.5-25 kg/m2
- Blood pressure at rest less than 140/ 90 mmHg .
- Physical activity level: sedentary or light (< 3 hours of sport per week )
- Lack of sleep pathology ( including sleep apnea and insomnia )
Key exclusion criteria (21 listed)
- Current smoking
- Family history of diabetes
- History of sleep disorders
- Circadian Typology by Horne \& Ostberg [ 16-30 ] or [ 70-86 ]
- Score questionnaire Pittsburgh Sleep Quality Inde x> 5
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 |
|---|---|---|
| Overfeeding (130 % of energy requirements )Overfeeding (130 % of energy requirements ) | Dietary supplement | Overfeeding + normal sleep duration, Overfeeding + sleep restriction |
| Sleep restriction (4 hours per night)Sleep restriction (4 hours per night) | Behavioural | Overfeeding + sleep restriction |
Primary outcome
Accumulation of fat in the liver (measured by nuclear magnetic resonance ) and the tissue insulin sensitivity ( measured by a test meal ) in response to a sleep restriction in overfeeding condition .
Time frame: After 6 days of sleep restriction (4 h/day) vs. normal sleep (8 h/day)
1 secondary outcome
Blood concentrations of circulating fatty acids and glycerol
Time frame: After 6 days of sleep restriction (4 h/day) vs. normal sleep (8 h/day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Derived from this study: PubMed 30615104Cros J, Pianezzi E, Rosset R, Egli L, Schneiter P, Cornette F, Pouymayou B, Heinzer R, Tappy L, Kreis R, Boesch C, Haba-Rubio J, Lecoultre V. Impact of sleep restriction on metabolic outcomes induced by overfeeding: a randomized controlled trial in healthy individuals. Am J Clin Nutr. 2019 Jan 1;109(1):17-28. doi: 10.1093/ajcn/nqy215.
- Center for Investigation and Research on Sleep, University Hospital, Lausanne, SwitzerlandLink provided by the sponsor.
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Healthy Adult Participants
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.
Center for Investigation and Reseaarch on Sleep and Physiology Department, University Hospital
Lausanne, Switzerland
José Haba-Rubio, MD principal investigator
Center for Investigation and Research on Sleep, University Hospital, Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overfeeding (130 % of energy requirements ) and Sleep restriction (4 hours per night) in people with Sleep, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 10 inclusion and 21 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 27 May 2015. 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 Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accumulation of fat in the liver (measured by nuclear magnetic resonance ) and the tissue insulin sensitivity ( measured by a test meal ) in response to a sleep restriction in overfeeding condition . (time frame: After 6 days of sleep restriction (4 h/day) vs. normal sleep (8 h/day)). 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 NCT02075723, 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 27 May 2015.