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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Obstructive Sleep Apnea
• Intervention / Treatment: Behavioral: Diet

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04024-002
    • Universidade Federal de Sao Paulo
  • São Paulo, Brazil, 04023-062
    • Departamento de Psicobiologia - Universidade Federal de São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obese Apneic carbohydrate diet; Obese apneic individuals will be subject to a energy restriction diet rich in carbohydrates	Behavioral: Diet; Reduction of energy intake in order to weight loss; Other Names: Energy restriction
Experimental: Obese Apneic protein diet; Obese apneic individuals will be subject to a energy restricted diet rich in protein	Behavioral: Diet; Reduction of energy intake in order to weight loss; Other Names: Energy restriction
Experimental: Obese Non Apneic carbohydrate diet; Obese individuals without Obstructive sleep apnea will be subjected to a energy restricted diet rich in carbohydrates	Behavioral: Diet; Reduction of energy intake in order to weight loss; Other Names: Energy restriction
Experimental: Obese Non Apneic protein diet; Obese individuals without Obstructive Sleep Apnea will be subjected to a energy restricted diet rich in protein	Behavioral: Diet; Reduction of energy intake in order to weight loss; Other Names: Energy restriction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Composition	Bodu composition evaluation by pletismografy to determine fat mass and fat free mass	Baseline, 1 month, 2 months and 4 months

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: November 4, 2013
• First Submitted That Met QC Criteria: November 14, 2013
• First Posted (Estimate): November 15, 2013

Study Record Updates

• Last Update Posted (Estimate): July 4, 2016
• Last Update Submitted That Met QC Criteria: July 1, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; obesity; diet; energy expenditure
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Body Weight; Signs and Symptoms, Respiratory; Body Weight Changes; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Weight Loss
• Other Study ID Numbers: RMR-PRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED