Whole Food Plant-based Diet Effect on Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Effect of Whole Food Plant-based Diet in Patients With Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06395181
• Other study ID #: 23-011675
• Status: Recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Daytime Sleepiness
• Disorders of Excessive Somnolence
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleepiness

Intervention

Behavioral:
• Whole Food Plant-Based Diet
A whole food, plant-based diet focuses on whole foods that are not processed. The diet places an emphasis on plant foods that are naturally lower in fat and includes eating a variety of plant foods (fruits, vegetables, beans and legumes, whole grains, nuts and seeds, spices and herbs).

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in daytime sleepiness	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.	Baseline, 8 weeks
Primary	Change in Apnea-Hypopnea Index (AHI)	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.	Baseline, 8 weeks
Secondary	Change in weight	Measured in kilograms (kg)	Baseline, 8 weeks