Clinical trial NCT01985035: Influence of Obstructive Sleep Apnea on Metabolism and Weight Loss in Obese Individuals
Official title: Influence of Obstructive Sleep Apnea on Metabolism and Weight Loss in Obese Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Obesity
Keywords: Obstructive sleep apnea
obesity
diet
energy expenditure
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2013-11-15
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Energy expenditure
timeFrame: up to 4 months
Secondary outcomes:
measure: Body Composition
timeFrame: Baseline, 1 month, 2 months and 4 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Departamento de Psicobiologia - Universidade Federal de São Paulo
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo
Study officials:
References:
citation: de Melo CM, Dos Santos Quaresma MVL, Del Re MP, Ribeiro SML, Moreira Antunes HK, Togeiro SM, Tufik S, de Mello MT. One-month of a low-energy diet, with no additional effect of high-protein, reduces Obstructive Sleep Apnea severity and improve metabolic parameters in obese males. Clin Nutr ESPEN. 2021 Apr;42:82-89. doi: 10.1016/j.clnesp.2020.12.028. Epub 2021 Feb 11.