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

NCT ID: NCT01985035

Last Updated: 2016-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-08-31

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.

Conditions

Obstructive Sleep Apnea; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Obese Apneic carbohydrate diet

Obese apneic individuals will be subject to a energy restriction diet rich in carbohydrates

Group Type: EXPERIMENTAL

Diet

Intervention Type: BEHAVIORAL

Reduction of energy intake in order to weight loss

Obese Apneic protein diet

Obese apneic individuals will be subject to a energy restricted diet rich in protein

Group Type: EXPERIMENTAL

Diet

Intervention Type: BEHAVIORAL

Reduction of energy intake in order to weight loss

Obese Non Apneic carbohydrate diet

Obese individuals without Obstructive sleep apnea will be subjected to a energy restricted diet rich in carbohydrates

Group Type: EXPERIMENTAL

Diet

Intervention Type: BEHAVIORAL

Reduction of energy intake in order to weight loss

Obese Non Apneic protein diet

Obese individuals without Obstructive Sleep Apnea will be subjected to a energy restricted diet rich in protein

Group Type: EXPERIMENTAL

Diet

Intervention Type: BEHAVIORAL

Reduction of energy intake in order to weight loss

Interventions

Diet

Reduction of energy intake in order to weight loss

Intervention Type: BEHAVIORAL

Other Intervention Names

Energy restriction

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Camila Maria de Melo

Msc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Departamento de Psicobiologia - Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 33745625 (View on PubMed)

Other Identifiers

RMR-PRO

Identifier Type: -

Identifier Source: org_study_id