Effects of Time of Sleep Restriction in Obesity

August 14, 2014 updated by: Iona Zalcman Zimberg, Federal University of São Paulo

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

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sao Paulo, Brazil, 04020-060
        • Centro de Estudos em Psicobiologia e Exercicio (CEPE)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

primary care clinic, community sample, residents of the city of Sao Paulo

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Obesity
BMI > 30kg/m2
Normal weight
BMI between 19 and 24,9kg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite regulating hormones and stress hormones
Time Frame: Measured every hour over the course of 24 hours on day 3
Hormones are sampled from blood
Measured every hour over the course of 24 hours on day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hunger and satiety
Time Frame: Measured every 4 hour over the course of 12 hours on day 2 and 3
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
Food intake
Time Frame: measured each meal
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marco Tulio de Mello, PHD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 13, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (Estimate)

December 14, 2010

Study Record Updates

Last Update Posted (Estimate)

August 18, 2014

Last Update Submitted That Met QC Criteria

August 14, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

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.

Clinical Trials on Obesity

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