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Completed

NCT Number: NCT05706649

A Study 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.

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Key information

Conditions

Drowsiness Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleepiness

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plant-based diet

Behavioral

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Effect of Plant-based Diet on Postprandial Sleepiness

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2023
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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