DrowsinessNCT05706649
A Study of Plant-based Diet on Postprandial Sleepiness
A study testing Plant-based diet in people with Drowsiness, run by Mayo Clinic at 1 site in United States.
Trial summary
This research aims to develop a better understanding and clinical knowledge of the effects of a plant-based diet on postprandial sleepiness. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Drowsiness
- What is being tested?
- Plant-based diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2023to 10 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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'.
Who cannot join
- Diabetes.
- Pregnancy or lactation.
- Current use of a vegan/plant-based diet
- BMI ≤ 22.
- Iron deficiency.
- Vitamin B12 deficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Drowsiness
- Being tested
- Plant-based diet
- Keywords
- Postprandial Sleepiness
- Medical subject headings
- Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based dietBehavioural
21 day diet that excludes any form of meat and other animal products, including dairy products.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Plant-based diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start31 Jan 2023
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DrowsinessStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Y. Cheung, Mayo Clinic
- Investigators
- Joseph Cheung, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706649
- Sponsor's protocol ID
- 22-011794
- Status last verified
- Jun 2023
- First submitted
- 23 Jan 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plant-based Diet on Postprandial Sleepiness
- ClinicalTrials.gov ID
- NCT05706649
- Acronym / sponsor ID
- 22-011794
- Conditions
- Drowsiness
- Keywords
- Postprandial Sleepiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research aims to develop a better understanding and clinical knowledge of the effects of a plant-based diet on postprandial sleepiness.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plant-based diet | Experimental | Behavioral: Plant-based dietSubjects will receive a handbook on plant-based diet including recipe recommendations. They will follow a strict plant-based diet for 21 day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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'.
Key exclusion criteria (6 listed)
- Diabetes.
- Pregnancy or lactation.
- Current use of a vegan/plant-based diet
- BMI ≤ 22.
- Iron deficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant-based diet21 day diet that excludes any form of meat and other animal products, including dairy products. | Behavioural | Plant-based diet |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Cheung, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-based diet in people with Drowsiness, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postprandial sleepiness (time frame: Baseline, 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.