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Completed

NCT Number: NCT01259895

Effects of Time of Sleep Restriction in Obesity

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.

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Key information

Age range

20 year–35 year

Sex eligibility

Male

Study type

Observational

Primary location

Centro de Estudos em Psicobiologia e Exercicio (CEPE)

São Paulo, 04020-060, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Associacao Fundo de Incentivo a Psicofarmcologia
  • Centro de Estudos em Sonolência e Acidentes

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Dec 14, 2010
Registry last updated
Aug 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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