Effects of Time of Sleep Restriction in Obesity

NCT ID: NCT01259895

Last Updated: 2014-08-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-06-30

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.

Conditions

Obesity; Sleep Restriction; Appetite Regulation; Eating

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Obesity

BMI \> 30kg/m2

No interventions assigned to this group

Normal weight

BMI between 19 and 24,9kg/m2

No interventions assigned to this group

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Associacao Fundo de Incentivo a Psicofarmcologia

OTHER

Sponsor Role: collaborator

Centro de Estudos em Sonolência e Acidentes

OTHER

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Iona Zalcman Zimberg

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Tulio de Mello, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Centro de Estudos em Psicobiologia e Exercicio (CEPE)

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

FAPESP2008/09565-2

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CEPE18

Identifier Type: -

Identifier Source: org_study_id