A Study of Plant-based Diet on Postprandial Sleepiness

NCT05706649 | Completed

• 1 other identifier: 22-011794
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drowsiness

Keywords

Postprandial Sleepiness

Outcome Measures

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.

  Baseline, 21 days

Study Arms (1)

Plant-based diet

EXPERIMENTAL

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

Plant-based diet BEHAVIORAL

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

Plant-based diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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'.

You may not qualify if:

• Diabetes.
• Pregnancy or lactation.
• Current use of a vegan/plant-based diet
• BMI ≤ 22.
• Iron deficiency.
• Vitamin B12 deficiency.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sleepiness

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Joseph Cheung, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: January 31, 2023
• Study Start: January 31, 2023
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)