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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01985035
Enrollment
60
Registered
2013-11-15
Start date
2013-10-31
Completion date
2015-08-31
Last updated
2016-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea, obesity, diet, energy expenditure

Brief 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.

Interventions

BEHAVIORALDiet

Reduction of energy intake in order to weight loss

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Energy expenditureup to 4 monthsMeasurements of energy expenditure by doubly labeled water for day energy expenditure and by calorimetry for resting energy expenditure and thermic effect of food

Secondary

MeasureTime frameDescription
Body CompositionBaseline, 1 month, 2 months and 4 monthsBodu composition evaluation by pletismografy to determine fat mass and fat free mass

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026