Obesity Clinical Trial
Official title:
Effect os Sleep Restriction on Control of Food Intake and Metabolism of Obese Subjects
Verified date | August 2014 |
Source | Federal University of São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 2012 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 35 Years |
Eligibility |
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. |
Observational Model: Case-Crossover, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Brazil | Centro de Estudos em Psicobiologia e Exercicio (CEPE) | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo | Associacao Fundo de Incentivo a Psicofarmcologia, Centro de Estudos em Sonolência e Acidentes |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Appetite regulating hormones and stress hormones | Hormones are sampled from blood | Measured every hour over the course of 24 hours on day 3 | No |
Secondary | Hunger and satiety | Hunger and saciety are measured using visual analogue scales before and after breakfast, lunch and dinner meal | Measured every 4 hour over the course of 12 hours on day 2 and 3 | No |
Secondary | 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 each meal | No |
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