Effects of Time of Sleep Restriction in Obesity

NCT01259895 | Completed

• 2 other identifiers: CEPE18FAPESP2008/09565-2
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Sleep Restriction; Appetite Regulation; Eating

Outcome Measures

Primary Outcomes (1)

• Appetite regulating hormones and stress hormones

  Hormones are sampled from blood

  Measured every hour over the course of 24 hours on day 3

Secondary Outcomes (2)

• Hunger and satiety

  Measured every 4 hour over the course of 12 hours on day 2 and 3

• Food intake

  measured each meal

Study Arms (2)

Obesity

BMI \> 30kg/m2

Normal weight

BMI between 19 and 24,9kg/m2

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• obese (BMI\>30) and normal weight (BMI between 19 and 24,9)
• regular time of sleep between 6.5 and 8 hours

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Associacao Fundo de Incentivo a Psicofarmcologia: collaborator
• Centro de Estudos em Sonolência e Acidentes: collaborator

Study Sites (1)

Centro de Estudos em Psicobiologia e Exercicio (CEPE)

São Paulo, São Paulo, 04020-060, Brazil

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Tulio de Mello, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 14, 2010
• Study Start: February 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: June 1, 2012
• Last Updated: August 18, 2014

Record last verified: 2014-08

Locations

BR (1)