ObesityNCT01259895
Effects of Time of Sleep Restriction in Obesity
An observational study of Obesity and Sleep Restriction, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine the effect of different time of sleep restriction on control of food intake and metabolism of obese and normal subjects. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Sleep Restriction, Appetite Regulation
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2009to Jun 2012
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: primary care clinic, community sample, residents of the city of Sao Paulo
Who may be able to join
- obese (BMI>30) and normal weight (BMI between 19 and 24,9)
- regular time of sleep between 6.5 and 8 hours
Who cannot join
- self-reported sleep problems (Pittsburgh Sleep Quality Index score >5);
- Obstructive sleep apnea (AHI > 5 in polysomnography)
- night work;
- variable sleep habits or habitual daytime naps;
- regular physical exercise (>3 hours/week);
- excessive intake of alcohol (>7 drinks/week);
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- excessive intake of caffeine (>300 mg/day);
- smoking;
- substance abuse;
- use of prescription medications or over-the-counter drugs affecting sleep or metabolism;
- chronic diseases (e.g. cancer, asthma, back pain, thyroid disease, heart disease, diabetes, etc.)
- history of neurological, medical or sleep disorders;
- trans-meridian travelling the last month;
- chronotype: extreme morning or extreme evening
- unable to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Estudos em Psicobiologia e Exercicio (CEPE)
São Paulo, São Paulo, 04020-060
About this study
Official title: Effect os Sleep Restriction on Control of Food Intake and Metabolism of Obese Subjects
The purpose of this study is to determine the effect of different time of sleep restriction on control of food intake and metabolism of obese and normal subjects.
Read the detailed description
The reduction of sleep time has now become a common habit, driven by the demands and opportunities of modern society. Some studies have suggested that sleep restriction would be an important factor in predisposing to obesity. However studies of sleep restriction in obese individuals have not yet been conducted. Still, the time of sleep restriction varies greatly between studies, making it difficult to compare results.
The investigators aim to recruit 20 young adults, 10 obese and 10 normal weight individuals. The study will be conducted as a randomized, crossover study with three conditions. Each participant will be subjected to reduction of the beginning of sleep (from 3-7h), reduction of the end of sleep (from 23-3h), and normal sleep (from 23-7h), in random order, for three consecutive nights.
In each condition, subjects will stay for 4 days in the laboratory. Three control meals will be offered. Visual analogue scales will be applied before and after each meal to assess hunger and appetite for different food categories. Blood samples will be collected hourly during 24 hours.
- Conditions
- Obesity, Sleep Restriction, Appetite Regulation, Eating
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obesity | BMI > 30kg/m2 | |
| Normal weight | BMI between 19 and 24,9kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite regulating hormones and stress hormones
Hormones are sampled from blood
Measured: Measured every hour over the course of 24 hours on day 3
Secondary outcomes (2)
Hunger and satiety
Hunger and saciety are measured using visual analogue scales before and after breakfast, lunch and dinner meal
Measured: Measured every 4 hour over the course of 12 hours on day 2 and 3
Food intake
The meal will be weighted before and after the breakfast, lunch and dinner. Energy and nutrient intake are assessed from the amount of the meal consumed.
Measured: measured each meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startFeb 2009
- Primary completionSep 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Associacao Fundo de Incentivo a Psicofarmcologia, Centro de Estudos em Sonolência e Acidentes
- Responsible party
- Principal investigator, Iona Zalcman Zimberg, Federal University of São Paulo
- Investigators
- Marco Tulio de Mello, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259895
- Sponsor's protocol ID
- CEPE18
- Other IDs
- FAPESP2008/09565-2
- Status last verified
- Aug 2014
- First submitted
- 13 Dec 2010
- Last updated
- 18 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect os Sleep Restriction on Control of Food Intake and Metabolism of Obese Subjects
- ClinicalTrials.gov ID
- NCT01259895
- Acronym / sponsor ID
- CEPE18
- Conditions
- Obesity, Sleep Restriction, Appetite Regulation, Eating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Associacao Fundo de Incentivo a Psicofarmcologia, Centro de Estudos em Sonolência e Acidentes
- Study start
- Feb 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Dec 2010 (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 the effect of different time of sleep restriction on control of food intake and metabolism of obese and normal subjects.
Detailed description
The reduction of sleep time has now become a common habit, driven by the demands and opportunities of modern society. Some studies have suggested that sleep restriction would be an important factor in predisposing to obesity. However studies of sleep restriction in obese individuals have not yet been conducted. Still, the time of sleep restriction varies greatly between studies, making it difficult to compare results.
The investigators aim to recruit 20 young adults, 10 obese and 10 normal weight individuals. The study will be conducted as a randomized, crossover study with three conditions. Each participant will be subjected to reduction of the beginning of sleep (from 3-7h), reduction of the end of sleep (from 23-3h), and normal sleep (from 23-7h), in random order, for three consecutive nights.
In each condition, subjects will stay for 4 days in the laboratory. Three control meals will be offered. Visual analogue scales will be applied before and after each meal to assess hunger and appetite for different food categories. Blood samples will be collected hourly during 24 hours.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obesity | – | –BMI > 30kg/m2 |
| Normal weight | – | –BMI between 19 and 24,9kg/m2 |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- primary care clinic, community sample, residents of the city of Sao Paulo
Key inclusion criteria (2 listed)
- obese (BMI>30) and normal weight (BMI between 19 and 24,9)
- regular time of sleep between 6.5 and 8 hours
Key exclusion criteria (15 listed)
- self-reported sleep problems (Pittsburgh Sleep Quality Index score >5);
- Obstructive sleep apnea (AHI > 5 in polysomnography)
- night work;
- variable sleep habits or habitual daytime naps;
- regular physical exercise (>3 hours/week);
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
Appetite regulating hormones and stress hormones
Time frame: Measured every hour over the course of 24 hours on day 3
Hormones are sampled from blood
2 secondary outcomes
Hunger and satiety
Time frame: Measured every 4 hour over the course of 12 hours on day 2 and 3
Food intake
Time frame: measured each meal
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 18 Aug 2014.
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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.
Marco Tulio de Mello, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Sleep Restriction, run by Federal University of São Paulo at 1 site in Brazil.
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 2 inclusion and 15 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 18 Aug 2014. 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 Brazil. 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?
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?
Appetite regulating hormones and stress hormones (time frame: Measured every hour over the course of 24 hours on day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2014.