- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01259895
Effects of Time of Sleep Restriction in Obesity
Effect os Sleep Restriction on Control of Food Intake and Metabolism of Obese Subjects
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sao Paulo, Brazil, 04020-060
- Centro de Estudos em Psicobiologia e Exercicio (CEPE)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- obese (BMI>30) and normal weight (BMI between 19 and 24,9)
- regular time of sleep between 6.5 and 8 hours
Exclusion Criteria:
- 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);
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Obesity
BMI > 30kg/m2
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Normal weight
BMI between 19 and 24,9kg/m2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Appetite regulating hormones and stress hormones
Time Frame: Measured every hour over the course of 24 hours on day 3
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Hormones are sampled from blood
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Measured every hour over the course of 24 hours on day 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Hunger and satiety
Time Frame: Measured every 4 hour over the course of 12 hours on day 2 and 3
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Hunger and saciety are measured using visual analogue scales before and after breakfast, lunch and dinner meal
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Measured every 4 hour over the course of 12 hours on day 2 and 3
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Food intake
Time Frame: measured each meal
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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.
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measured each meal
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marco Tulio de Mello, PHD, Federal University of São Paulo
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEPE18
- FAPESP2008/09565-2 (Other Grant/Funding Number: FAPESP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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