Effects of Time of Sleep Restriction in Obesity

Obesity Clinical Trial

Official title:

Effect os Sleep Restriction on Control of Food Intake and Metabolism of Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259895
• Other study ID #: CEPE18
• Secondary ID: FAPESP2008/09565
• Status: Completed
• Phase: N/A
• First received: December 13, 2010
• Last updated: August 14, 2014
• Start date: February 2009
• Est. completion date: June 2012

Study information

• 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

Clinical 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Appetite Regulation
• Eating
• Obesity
• Sleep Restriction

Locations

Country	Name	City	State
Brazil	Centro de Estudos em Psicobiologia e Exercicio (CEPE)	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of São Paulo	Associacao Fundo de Incentivo a Psicofarmcologia, Centro de Estudos em Sonolência e Acidentes

Country where clinical trial is conducted

Brazil, 

Outcome

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

External Links

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