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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01985035
Other study ID # RMR-PRO
Secondary ID
Status Completed
Phase N/A
First received November 4, 2013
Last updated July 1, 2016
Start date October 2013
Est. completion date August 2015

Study information

Verified date July 2016
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 45 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Brazil Departamento de Psicobiologia - Universidade Federal de São Paulo São Paulo
Brazil Universidade Federal de São Paulo São Paulo

Sponsors (2)

Lead Sponsor Collaborator
Federal University of São Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Body Composition Bodu composition evaluation by pletismografy to determine fat mass and fat free mass Baseline, 1 month, 2 months and 4 months Yes
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