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

NCT01985035 | Completed

• 1 other identifier: RMR-PRO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Keywords

Obstructive sleep apnea; obesity; diet; energy expenditure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Body Composition

  Baseline, 1 month, 2 months and 4 months

Study Arms (4)

Obese Apneic carbohydrate diet

EXPERIMENTAL

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

Behavioral: Diet

Obese Apneic protein diet

EXPERIMENTAL

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

Behavioral: Diet

Obese Non Apneic carbohydrate diet

EXPERIMENTAL

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

Behavioral: Diet

Obese Non Apneic protein diet

EXPERIMENTAL

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

Behavioral: Diet

Interventions

Diet BEHAVIORAL

Reduction of energy intake in order to weight loss

Also known as: Energy restriction

Obese Apneic carbohydrate diet; Obese Apneic protein diet; Obese Non Apneic carbohydrate diet; Obese Non Apneic protein diet

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index between 30 and 40 kg/m2;
• Obstructive sleep apnea mild or severe;
• Sedentary.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (2)

Departamento de Psicobiologia - Universidade Federal de São Paulo

São Paulo, São Paulo, 04023-062, Brazil

Location

Universidade Federal de São Paulo

São Paulo, São Paulo, 04024-002, Brazil

Location

Related Publications (1)

• 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.

  PMID: 33745625 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 15, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 4, 2016

Record last verified: 2016-07

Locations

BR (2)