Back to resultsA Study of Plant-based Diet on Postprandial Sleepiness
Primary Purpose
Drowsiness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Plant-based diet
Sponsored by
About this trial
This is an interventional other trial for Drowsiness focused on measuring Postprandial Sleepiness
Eligibility Criteria
Inclusion Criteria Sleepiness after eating lunch. ESS score ≥3 for answering the question about these two situations: 'sitting quietly after lunch without alcohol' and 'lying down to rest in the afternoon when circumstances permit'. Exclusion Criteria Diabetes. Pregnancy or lactation. Current use of a vegan/plant-based diet BMI ≤ 22. Iron deficiency. Vitamin B12 deficiency.
Sites / Locations
- Mayo Clinic Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Plant-based diet
Arm Description
Subjects will receive a handbook on plant-based diet including recipe recommendations. They will follow a strict plant-based diet for 21 day.
Outcomes
Primary Outcome Measures
Change in postprandial sleepiness
Measured by Epworth Sleepiness Questionnaire before and after a plant-based diet. The Epworth sleepiness scale (ESS) 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05706649
Brief Title
A Study of Plant-based Diet on Postprandial Sleepiness
Official Title
Effect of Plant-based Diet on Postprandial Sleepiness
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
April 10, 2023 (Actual)
Study Completion Date
April 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research aims to develop a better understanding and clinical knowledge of the effects of a plant-based diet on postprandial sleepiness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drowsiness
Keywords
Postprandial Sleepiness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plant-based diet
Arm Type
Experimental
Arm Description
Subjects will receive a handbook on plant-based diet including recipe recommendations. They will follow a strict plant-based diet for 21 day.
Intervention Type
Behavioral
Intervention Name(s)
Plant-based diet
Intervention Description
21 day diet that excludes any form of meat and other animal products, including dairy products.
Primary Outcome Measure Information:
Title
Change in postprandial sleepiness
Description
Measured by Epworth Sleepiness Questionnaire before and after a plant-based diet. The Epworth sleepiness scale (ESS) 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.
Time Frame
Baseline, 21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Sleepiness after eating lunch.
ESS score ≥3 for answering the question about these two situations: 'sitting quietly after lunch without alcohol' and 'lying down to rest in the afternoon when circumstances permit'.
Exclusion Criteria
Diabetes.
Pregnancy or lactation.
Current use of a vegan/plant-based diet
BMI ≤ 22.
Iron deficiency.
Vitamin B12 deficiency.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Cheung, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of Plant-based Diet on Postprandial Sleepiness
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