ClinicalTrials.gg
CompletedNCT05706649Updated Jun 13, 2023

A Study of Plant-based Diet on Postprandial Sleepiness

An interventional study of Plant-based diet in Drowsiness, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-13.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Drowsiness

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Keywords

  • Postprandial Sleepiness
03

In context

Sleepiness

92 studies on the registry are indexed under Sleepiness; 20 are open to participants now.

This study's enrollment of 12 is below the median of 62 across 62 interventional studies indexed under Sleepiness.

Browse Sleepiness studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria

  • Diabetes.
  • Pregnancy or lactation.
  • Current use of a vegan/plant-based diet
  • ≤ 22.
  • Iron deficiency.
  • Vitamin B12 deficiency.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralPlant-based diet

    21 day diet that excludes any form of meat and other animal products, including dairy products.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 21 days

07

Study locations

1 site
  • Mayo Clinic Florida
    Jacksonville, Florida 32224, United States
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05706649
Lead sponsor
Mayo Clinic
Responsible party
Joseph Y. Cheung (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jan 31, 2023
Start date
Jan 31, 2023
Primary completion
Apr 10, 2023
Completion
Apr 10, 2023
Last update
Jun 13, 2023

Study contacts

Joseph Cheung, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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