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OpenTrials
Completed

NCT Number: NCT01985035

Influence of Obstructive Sleep Apnea on Metabolism and Weight Loss in Obese Individuals

Obstructive sleep apnea (OSA) can impars body weight reduction by changes in body composition and energy expenditure. The objective of this study is to evaluate the influence of OSA in energy metabolism and body mass loss in obese subjects. Ninety obese volunteers of both genders, 45 diagnosed with OSA and 45 without OSA, will be submitted to a dietary intervention of one months. Volunteers will be distributed into four groups: obese OSA PTN with moderate protein diet (1.6 g / kg protein / day), obese OSA CHO diet (0.8 g / kg protein / day) with standard composition diet, obese NSAOS PTN diet moderate in protein and CHO NSAOS obese standard diet. All groups will be instructed to perform a restricted energy diet (less 30% of daily energy expenditure). At baseline and one month after the beginning of the program the following evaluations will be conducted: total energy expenditure measured by doubly labeled water method, resting energy expenditure and thermic effect of food by calorimetry, polysomnography analysis, body composition by pletysmography, food consumption by three days of food diary, blood collection for analysis of lipid profile, visceral proteins, hormones related to control of body weight and inflammation. As hypothesis we believe that apneic obese individuals have greater difficult in weight loss and loss more free fat mass than the obese no apneic and that diets with more protein can contribute to greater weight loss, better body composition and energy expenditure in these population.

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departamento de Psicobiologia - Universidade Federal de São Paulo, São Paulo, Brazil

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body Mass Index between 30 and 40 kg/m2;
  • Obstructive sleep apnea mild or severe;
  • Sedentary.

Exclusion criteria

  • Intake of any drug that interfere on metabolism such for thyroid or to lose weight;
  • Be engaged in other treatment for sleep apnea or obesity;
  • Present another sleep disorder;
  • Being shift work;
  • Present any kind of kidney disease.

Treatment and study plan

Diet

Behavioral

Reduction of energy intake in order to weight loss

Other names: Energy restriction

Primary outcomes

  1. Energy expenditure

    Time frame: up to 4 months

    Measurements of energy expenditure by doubly labeled water for day energy expenditure and by calorimetry for resting energy expenditure and thermic effect of food

Secondary outcomes

  1. Body Composition

    Time frame: Baseline, 1 month, 2 months and 4 months

    Bodu composition evaluation by pletismografy to determine fat mass and fat free mass

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 15, 2013
Registry last updated
Jul 4, 2016

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

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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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