A Study of Plant-based Diet on Postprandial Sleepiness

June 12, 2023 updated by: Joseph Y. Cheung, Mayo Clinic

Effect of Plant-based Diet on Postprandial Sleepiness

This research aims to develop a better understanding and clinical knowledge of the effects of a plant-based diet on postprandial sleepiness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plant-based diet
Subjects will receive a handbook on plant-based diet including recipe recommendations. They will follow a strict plant-based diet for 21 day.
Behavioral: Plant-based diet
21 day diet that excludes any form of meat and other animal products, including dairy products.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in postprandial sleepiness
Time Frame: Baseline, 21 days
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.
Baseline, 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Joseph Cheung, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Actual)

April 10, 2023

Study Completion (Actual)

April 10, 2023

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

January 31, 2023

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-011794

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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