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Whole Food Plant-based Diet Effect on Obstructive Sleep Apnea

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Mayo Clinic

Status

Enrolling

Conditions

Daytime Sleepiness
Obstructive Sleep Apnea

Treatments

Behavioral: Whole Food Plant-Based Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT06395181
23-011675

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Diet Group: Whole Food Plant Based Diet
Experimental group
Description:
Subjects with follow a whole food plant-based diet for 8 weeks.
Treatment:
Behavioral: Whole Food Plant-Based Diet
Control Group: Usual Care
No Intervention group
Description:
Subjects will not change their diet for 8 weeks.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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