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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 2015

Interventions

  • Behavioral: Diet
    • Reduction of energy intake in order to weight loss

Arms, Groups and Cohorts

  • Experimental: Obese Apneic carbohydrate diet
    • Obese apneic individuals will be subject to a energy restriction diet rich in carbohydrates
  • Experimental: Obese Apneic protein diet
    • Obese apneic individuals will be subject to a energy restricted diet rich in protein
  • Experimental: Obese Non Apneic carbohydrate diet
    • Obese individuals without Obstructive sleep apnea will be subjected to a energy restricted diet rich in carbohydrates
  • Experimental: Obese Non Apneic protein diet
    • Obese individuals without Obstructive Sleep Apnea will be subjected to a energy restricted diet rich in protein

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Federal University of São Paulo
  • Collaborator
    • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Camila Maria de Melo, Msc – Federal University of São Paulo

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