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

NCT02251574 | Completed

• 1 other identifier: STUDY00001418
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Change in Apnea Hypopnea Index (AHI)

  The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.

  Change from Baseline to Month 3

Secondary Outcomes (4)

• Change in Apnea Hypopnea Index (AHI)

  Change from Baseline to Month 9

• Change in metabolic syndrome (MetS) risk factors

  Change from Baseline to Month 3 and Month 9

• Change in Quality of Life

  Change from Baseline to Month 3 and Month 9

• Change in Daytime Sleepiness

  Change from Baseline to Month 3 and Month 9

Study Arms (3)

Low Calorie Diet

EXPERIMENTAL

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

Other: Low Calorie Diet

Very Low Calorie Diet

EXPERIMENTAL

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

Other: Very Low Calorie Diet

Standard Care

ACTIVE COMPARATOR

Participants will receive normal care.

Other: Standard Care

Interventions

Low Calorie Diet OTHER

Weight management program designed around a low calorie diet.

Low Calorie Diet

Very Low Calorie Diet OTHER

Weight management program designed around a very low calorie diet.

Very Low Calorie Diet

Standard Care OTHER

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

Standard Care

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Caloric Restriction; Standard of Care

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jeannine Goetz, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 29, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

US (1)