Trials / Completed
CompletedNCT01985035
Influence of Obstructive Sleep Apnea on Metabolism and Weight Loss in Obese Individuals
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Federal University of São Paulo · Academic / Other
- Sex
- All
- Age
- 25 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Diet | Reduction of energy intake in order to weight loss |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2013-11-15
- Last updated
- 2016-07-04
Locations
2 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01985035. Inclusion in this directory is not an endorsement.