Clinical trial NCT01259895: Effects of Time of Sleep Restriction in Obesity
Official title: Effect os Sleep Restriction on Control of Food Intake and Metabolism of Obese Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Sleep Restriction
Appetite Regulation
Eating
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Associacao Fundo de Incentivo a Psicofarmcologia
name: Centro de Estudos em Sonolência e Acidentes
First posted: 2010-12-14
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic, community sample, residents of the city of Sao Paulo

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Appetite regulating hormones and stress hormones
timeFrame: Measured every hour over the course of 24 hours on day 3
Secondary outcomes:
measure: Hunger and satiety
timeFrame: Measured every 4 hour over the course of 12 hours on day 2 and 3
measure: Food intake
timeFrame: measured each meal
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Centro de Estudos em Psicobiologia e Exercicio (CEPE)
Study officials:
affiliation: Federal University of São Paulo
name: Marco Tulio de Mello, PhD
role: PRINCIPAL_INVESTIGATOR
References: