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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obstructive Sleep Apnea, Obesity

Intervention / Treatment
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* Behavioral: Diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obese Apneic carbohydrate diet<br>Obese apneic individuals will be subject to a energy restriction diet rich in carbohydrates | Behavioral: Diet<br>* Reduction of energy intake in order to weight loss<br>* Other names: Energy restriction;|
| Experimental: Obese Apneic protein diet<br>Obese apneic individuals will be subject to a energy restricted diet rich in protein | Behavioral: Diet<br>* Reduction of energy intake in order to weight loss<br>* Other names: Energy restriction;|
| Experimental: Obese Non Apneic carbohydrate diet<br>Obese individuals without Obstructive sleep apnea will be subjected to a energy restricted diet rich in carbohydrates | Behavioral: Diet<br>* Reduction of energy intake in order to weight loss<br>* Other names: Energy restriction;|
| Experimental: Obese Non Apneic protein diet<br>Obese individuals without Obstructive Sleep Apnea will be subjected to a energy restricted diet rich in protein | Behavioral: Diet<br>* Reduction of energy intake in order to weight loss<br>* Other names: Energy restriction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy expenditure | Measurements of energy expenditure by doubly labeled water for day energy expenditure and by calorimetry for resting energy expenditure and thermic effect of food | up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition | Bodu composition evaluation by pletismografy to determine fat mass and fat free mass | Baseline, 1 month, 2 months and 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive sleep apnea, obesity, diet, energy expenditure