HealthyNCT00986492
Effects of Sleep Deprivation on Food Intake and Motor Activity in Man
An observational study of Healthy, run by University Hospital, Caen.
Trial summary
Evidence that shortened period of sleep could be a risk factor for weight gain and obesity has grown over the past decade. Concurrent with the obesity epidemic, numerous studies have reported a parallel epidemic of chronic sleep deprivation. Sleep is important in maintaining energy balance (i.e. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Jun 2009
- Phase
- Observational
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy normal subjects
Who may be able to join
- male
- age between 18 and 30
- healthy
- non smoker
- less than 5 hour of sport per week
- BMI between 20 and 25 kg/m/m
Who cannot join
- eating disorders,
- dieting or fasting
- restrained (score >9), disinhibited (score >11) or hungry subjects (score >9), according to the Three-Factor Eating Questionnaire general healthiness,
- food-snacking (more than twice a day),
About this study
Official title: Influence de la Privation Aigue de Sommeil Sur la Prise Alimentaire et l'activité Physique Chez l'Homme
Evidence that shortened period of sleep could be a risk factor for weight gain and obesity has grown over the past decade. Concurrent with the obesity epidemic, numerous studies have reported a parallel epidemic of chronic sleep deprivation. Sleep is important in maintaining energy balance (i.e. acute sleep deprivation impact the normal secretion of ghrelin and decreases leptin plasma levels). Surprisingly, in humans, there is no direct evidence that a shortened night has direct effect on energy metabolism during the following day.
This study is set up to determine whether a partial sleep deprivation night has an impact on appetite and food energy intake and, concomitantly, on physical activity, during the following day.
- Conditions
- Healthy
- Keywords
- Sleep deprivation, Food intake, Motor activity, Normal, healthy subjects
- Medical subject headings
- Sleep Deprivation, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily food intake
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2009
- Study completionJun 2009
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 HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon
- Investigators
- Pierre Denise, MD, PhD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986492
- Sponsor's protocol ID
- 2009-A00297-50
- Status last verified
- Sep 2009
- First submitted
- 24 Sep 2009
- Last updated
- 30 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Brondel L, Romer MA, Nougues PM, Touyarou P, Davenne D. Acute partial sleep deprivation increases food intake in healthy men. Am J Clin Nutr. 2010 Jun;91(6):1550-9. doi: 10.3945/ajcn.2009.28523. Epub 2010 Mar 31.
PubMed 20357041
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence de la Privation Aigue de Sommeil Sur la Prise Alimentaire et l'activité Physique Chez l'Homme
- ClinicalTrials.gov ID
- NCT00986492
- Acronym / sponsor ID
- 2009-A00297-50
- Conditions
- Healthy
- Keywords
- Sleep deprivation, Food intake, Motor activity, Normal, healthy subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon
- Study start
- Apr 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 30 Sep 2009 (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.
Evidence that shortened period of sleep could be a risk factor for weight gain and obesity has grown over the past decade. Concurrent with the obesity epidemic, numerous studies have reported a parallel epidemic of chronic sleep deprivation. Sleep is important in maintaining energy balance (i.e. acute sleep deprivation impact the normal secretion of ghrelin and decreases leptin plasma levels). Surprisingly, in humans, there is no direct evidence that a shortened night has direct effect on energy metabolism during the following day.
This study is set up to determine whether a partial sleep deprivation night has an impact on appetite and food energy intake and, concomitantly, on physical activity, during the following day.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy normal subjects
Key inclusion criteria (6 listed)
- male
- age between 18 and 30
- healthy
- non smoker
- less than 5 hour of sport per week
Key exclusion criteria (4 listed)
- eating disorders,
- dieting or fasting
- restrained (score >9), disinhibited (score >11) or hungry subjects (score >9), according to the Three-Factor Eating Questionnaire general healthiness,
- food-snacking (more than twice a day),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Daily food intake
Time frame: 24h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2009.
- Derived from this study: PubMed 20357041Brondel L, Romer MA, Nougues PM, Touyarou P, Davenne D. Acute partial sleep deprivation increases food intake in healthy men. Am J Clin Nutr. 2010 Jun;91(6):1550-9. doi: 10.3945/ajcn.2009.28523. Epub 2010 Mar 31.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Pierre Denise, MD, PhD principal investigator
University Hospital, Caen
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University Hospital, Caen.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 30 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily food intake (time frame: 24h). 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 NCT00986492, 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 30 Sep 2009.