Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults

NCT ID: NCT02251574

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-06-30

Brief Summary

The purpose of this study is to test the effectiveness of two different weight loss diets on obstructive sleep apnea (OSA) severity.

Detailed Description

Sleep apnea is a sleep disorder in which breathing repeatedly stops and starts during sleep. The most common type is obstructive sleep apnea (OSA), which occurs when the muscles in your throat relax and block your airway during sleep. The most noticeable sign of OSA is snoring. OSA is a risk factor for other chronic conditions like type 2 diabetes, cardiovascular disease, and high blood pressure.

Although anyone can develop OSA, it commonly affects people who are obese. The more someone weighs, the more likely the OSA is to be severe. Weight loss is typically recommended for overweight individuals to help improve OSA. However, not enough research has been done for doctors to be able make specific recommendations to their patients.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low Calorie Diet

Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 1200-1500 calories per day.

Group Type: EXPERIMENTAL

Low Calorie Diet

Intervention Type: OTHER

Weight management program designed around a low calorie diet.

Very Low Calorie Diet

Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 520-800 calories per day.

Group Type: EXPERIMENTAL

Very Low Calorie Diet

Intervention Type: OTHER

Weight management program designed around a very low calorie diet.

Standard Care

Participants will receive normal care.

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

Care provided that would normally be given to people meeting eligibility criteria for this study.

Interventions

Low Calorie Diet

Weight management program designed around a low calorie diet.

Intervention Type: OTHER

Very Low Calorie Diet

Weight management program designed around a very low calorie diet.

Intervention Type: OTHER

Standard Care

Care provided that would normally be given to people meeting eligibility criteria for this study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• AHI score of ≥ 5
• Body mass index (BMI) between 30 to 49.9 kg/m2

Exclusion Criteria

• Report serious medical risk such as insulin-dependent diabetes, active cancer, recent cardiac event
• Currently or planning to become pregnant during the next 9 months
• Not weight stable (-4.6 kg) for 3 mos. prior to intake
• Report current participation in a weight reduction program involving diet or PA
• Unwilling to be randomized to 1 of 3 study groups
• Report symptomology of an eating disorder as determined by the Eating Attitudes Test
• Unable to participate in moderate intensity physical activity

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeannine Goetz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

STUDY00001418

Identifier Type: -

Identifier Source: org_study_id