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

University of Kansas

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Other: Very Low Calorie Diet; Other: Standard Care; Other: Low Calorie Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02251574

STUDY00001418

Details and patient eligibility

About

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

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 3 patient groups

Low Calorie Diet

Experimental group

Description:

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

Treatment:

Other: Low Calorie Diet

Very Low Calorie Diet

Experimental group

Description:

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

Treatment:

Other: Very Low Calorie Diet

Standard Care

Active Comparator group

Description:

Participants will receive normal care.

Treatment:

Other: Standard Care