Whole Food Plant-based Diet Effect on Obstructive Sleep Apnea

Not Applicable

Recruiting

• Conditions: Daytime Sleepiness; Obstructive Sleep Apnea
• Interventions: Behavioral: Whole Food Plant-Based Diet

• Registration Number: NCT06395181
• Lead Sponsor: Mayo Clinic

Brief Summary

This research aims to develop a better understanding and clinical knowledge of the effects of a plant based diet on severity and daytime sleepiness in Obstructive Sleep Apnea.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-02
• Study Start: 2024-05-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Daytime sleepiness with ESS score ≥ 5.
• Patient's prior sleep study with AHI between ≥ 10 and ≤ 45 (4% scoring criterion).
• On treatment for OSA, failed or not willing to use all other OSA treatment options
• Has access to a weight scale at home or able to come into the Sleep Clinic to be weighed after the 8-week plant-based diet period.

Exclusion Criteria

• Pregnancy or lactation.
• Current use of a vegan diet.
• BMI ≤ 22.
• Complex, central sleep apnea.
• Pre-existing significant degree of cardio-pulmonary disease-heart failure with reduced EF of 35 or lower, unstable arrythmia, severe degree of pulmonary hypertension, severe degree of obstructive or restrictive lung disease including COPD and Interstitial lung disease.
• On weight loss medications or starting new exercise regimen during the 8-week plant-based diet period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diet Group: Whole Food Plant Based Diet	Whole Food Plant-Based Diet	Subjects with follow a whole food plant-based diet for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Apnea-Hypopnea Index (AHI)	Baseline, 8 weeks	Measured using the WatchPat One for at Home Sleep Apnea Test (HSAT), the Apnea-Hypopnea Index (AHI) assess severity of sleep apnea by counting apnea events during sleep. Normal range is less than 5 events per hour and severe is considered more than 30 events per hour.
Change in daytime sleepiness	Baseline, 8 weeks	Measured using The Epworth sleepiness scale (ESS) which is an 8-item questionnaire that measures daytime sleepiness in participants. Possible scores range from 0-24, with higher scores indicating a higher average sleep propensity in daily life, and a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Change in weight	Baseline, 8 weeks	Measured in kilograms (kg)

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States