search
Back to results

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

Primary Purpose

Obstructive Sleep Apnea, Obesity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Diet
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, obesity, diet, energy expenditure

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Departamento de Psicobiologia - Universidade Federal de São Paulo
  • Universidade Federal de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Obese Apneic carbohydrate diet

Obese Apneic protein diet

Obese Non Apneic carbohydrate diet

Obese Non Apneic protein diet

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Body Composition
Bodu composition evaluation by pletismografy to determine fat mass and fat free mass

Full Information

First Posted
November 4, 2013
Last Updated
July 1, 2016
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT01985035
Brief Title
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

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Obesity
Keywords
Obstructive sleep apnea, obesity, diet, energy expenditure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obese Apneic carbohydrate diet
Arm Type
Experimental
Arm Description
Obese apneic individuals will be subject to a energy restriction diet rich in carbohydrates
Arm Title
Obese Apneic protein diet
Arm Type
Experimental
Arm Description
Obese apneic individuals will be subject to a energy restricted diet rich in protein
Arm Title
Obese Non Apneic carbohydrate diet
Arm Type
Experimental
Arm Description
Obese individuals without Obstructive sleep apnea will be subjected to a energy restricted diet rich in carbohydrates
Arm Title
Obese Non Apneic protein diet
Arm Type
Experimental
Arm Description
Obese individuals without Obstructive Sleep Apnea will be subjected to a energy restricted diet rich in protein
Intervention Type
Behavioral
Intervention Name(s)
Diet
Other Intervention Name(s)
Energy restriction
Intervention Description
Reduction of energy intake in order to weight loss
Primary Outcome Measure Information:
Title
Energy expenditure
Description
Measurements of energy expenditure by doubly labeled water for day energy expenditure and by calorimetry for resting energy expenditure and thermic effect of food
Time Frame
up to 4 months
Secondary Outcome Measure Information:
Title
Body Composition
Description
Bodu composition evaluation by pletismografy to determine fat mass and fat free mass
Time Frame
Baseline, 1 month, 2 months and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Departamento de Psicobiologia - Universidade Federal de São Paulo
City
São Paulo
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
Universidade Federal de São Paulo
City
São Paulo
ZIP/Postal Code
04024-002
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33745625
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs