Diet, HealthyNCT04257201

Mushroom Ingestion Study

A study testing Yellow Oyster -- 84 g, Yellow Oyster -- 168 g and White button -- 84 g in people with Diet, Healthy, run by Purdue University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators propose to determine the effect of consuming 0, 1 or 2 servings of white button (Agaricus bisporus; most popular, lower ergothioneine) or yellow oyster (Pleurotus citrinopileatus; higher ergothioneine) mushrooms on postprandial changes in plasma levels and urinary excretions of mushroom-specific… Read more about this study

Who is it for?: Ages 30 to 69 yearsHealthy volunteers can take part
Conditions the study is for: Diet, Healthy
What is being tested?: Yellow Oyster -- 84 g, Yellow Oyster -- 168 g and White button -- 84 g
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 15 Aug 2020to 21 May 2021
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 30 to 69 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female;
age 30-69 y;
BMI: 25.0-34.9 kg/m2;
Not severely or extremely depressed (Beck's Depression Inventory score ≤30)
Total cholesterol <240 mg/dL, low-density lipoprotein cholesterol <160 mg/dL, triglycerides <400 mg/dL, fasting glucose <110 mg/dL;
Systolic/diastolic blood pressure <140/90 mm Hg;

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Body weight stable for 3 months prior (± 3 kg);
Stable physical activity regimen 3 months prior;
Medication use stable for 6 months prior;
Non-smoking;
Non-diabetic;
Not acutely ill;
Females not pregnant or lactating;
Participants must be willing and able to consume the prescribed diets and travel to testing facilities.

Who cannot join

BMI <25 or >35;
Severely depressed (Beck's Depression Inventory score >30);
Total cholesterol >240 mg/dL, low-density lipoprotein cholesterol >160 mg/dL, triglycerides >400 mg/dL, fasting glucose >110 mg/dL;
Body weight changes in previous 3 months (±3 kg);
Changes in physical activity regimen in the previous 3 months;
Medication changes in the previous 6 months;

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Smoking;
Diabetic;
Acute illness;
Pregnant or lactating;
Allergic to mushrooms

Trial locations and contacts

1 site in 1 country.

United States1 site

Purdue University
West Lafayette, Indiana, 47906

Other trials in United States

About this study

Read the detailed description

The investigators hypothesize that consuming different mushroom varieties will elicit distinct postprandial nutrimetabolomic profiles in the plasma and urine and that the amount of metabolites present will increase with the servings of mushrooms. Measuring ergothioneine in the plasma will provide a quantitative outcome to document the postprandial responses to consuming the test meals. The nutrimetabolomic related outcomes are exploratory and have not been documented in human research.

Conditions: Diet, Healthy
Being tested: Yellow Oyster -- 84 g, Yellow Oyster -- 168 g, White button -- 84 g, White button -- 168 g, Control
Keywords: Mediterranean, Mushrooms, Metabolomics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Yellow Oyster -- 84 gOther
Participants will consume the standardized test day salad plus 84 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served
Yellow Oyster -- 168 gOther
Participants will consume the standardized test day salad plus 168 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served
White button -- 84 gOther
Participants will consume the standardized test day salad plus 84 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served
White button -- 168 gOther
Participants will consume the standardized test day salad plus 168 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served
ControlOther
Participants will consume the standardized test day salad only

Study groups in NCT04257201
Study group	Role	What they receive
Control -- no mushrooms	Active comparator	Subjects will be randomized to consume a test day salad with 0 g, 84 g (yellow oyster or white button) or 168 g (yellow or white button) mushrooms. Mushrooms will be cooked prior to serving. Receives: Other: Control
Yellow Oyster -- 84 g	Experimental	Subjects will be randomized to consume a test day salad with 0 g, 84 g (yellow oyster or white button) or 168 g (yellow or white button) mushrooms. Mushrooms will be cooked prior to serving. Receives: Other: Yellow Oyster -- 84 g
Yellow Oyster -- 168 g	Experimental	Subjects will be randomized to consume a test day salad with 0 g, 84 g (yellow oyster or white button) or 168 g (yellow or white button) mushrooms. Mushrooms will be cooked prior to serving. Receives: Other: Yellow Oyster -- 168 g
White button -- 84 g	Experimental	Subjects will be randomized to consume a test day salad with 0 g, 84 g (yellow oyster or white button) or 168 g (yellow or white button) mushrooms. Mushrooms will be cooked prior to serving. Receives: Other: White button -- 84 g
White button 168 g	Experimental	Subjects will be randomized to consume a test day salad with 0 g, 84 g (yellow oyster or white button) or 168 g (yellow or white button) mushrooms. Mushrooms will be cooked prior to serving. Receives: Other: White button -- 168 g

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in plasma glucose
Plasma will be assessed for glucose values prior to salad consumption and in response to the test day meal
Measured: 5 hours
Change in plasma insulin
Plasma will be assessed for insulin values prior to salad consumption and in response to the test day meal
Measured: 5 hours
Plasma metabolomics
Plasma will be assessed for metabolomics (i.e. ergothioneine) via reverse phase liquid chromatography/mass spectrometry
Measured: 5 hours
Plasma ergothioneine
Plasma will be assessed for ergothioneine concentration, a compound unique to mushrooms
Measured: 5 hours
Plasma triglycerides
Plasma will be assessed for triglyceride values at the time of salad consumption and at each hour for 5 hours after salad consumption
Measured: 5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 202021 May 2021

First posted5 Feb 2020
Study start15 Aug 2020
Primary completion21 May 2021
Study completion21 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diet, HealthyStudies of the same condition, open and under way.
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: Randomised
Intervention model: Crossover
Model description: For this randomized crossover study, subjects will consume 5 test meals varying in mushroom content, each separated by a minimum of 10 days (Figure 1). For 3 days prior to each testing day participants will be provided with and instructed to exclusively consume a low-antioxidant "run-in" diet (low fruit, vegetable, and spice diet) to minimize background concentrations of potential test food-derived compounds of interest. On test days, participants will consume a standardized mixed-macronutrient meal (500 kcal, 75g CHO, 15g Protein, 15g Fat) containing 1) no mushrooms (control), 2) 84 g of raw white button mushrooms served cooked; 3) 168 g of raw white button mushrooms served cooked; 4) 84 g of raw yellow oyster mushrooms served cooked; or 5) 168 g of raw yellow oyster mushrooms served cooked. Between each run-in diet/testing period, participants will consume their usual, unrestricted self-selected diets for a minimum of 7 days.
Masking: Single blind
Who is masked: Investigator
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04257201
Sponsor's protocol ID: IRB-2019-645
Status last verified: Feb 2024
First submitted: 18 Dec 2019
Last updated: 16 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mushroom Ingestion Study
ClinicalTrials.gov ID: NCT04257201
Acronym / sponsor ID: IRB-2019-645
Conditions: Diet, Healthy
Keywords: Mediterranean, Mushrooms, Metabolomics
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Purdue UniversityUniversity, hospital or other
Collaborators: Mushroom Council
Study start: 15 Aug 2020 (actual)
Primary completion: 21 May 2021 (actual)
Study completion: 21 May 2021 (actual)
First posted: 5 Feb 2020 (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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 5
Model description: For this randomized crossover study, subjects will consume 5 test meals varying in mushroom content, each separated by a minimum of 10 days (Figure 1). For 3 days prior to each testing day participants will be provided with and instructed to exclusively consume a low-antioxidant "run-in" diet (low fruit, vegetable, and spice diet) to minimize background concentrations of potential test food-derived compounds of interest. On test days, participants will consume a standardized mixed-macronutrient meal (500 kcal, 75g CHO, 15g Protein, 15g Fat) containing 1) no mushrooms (control), 2) 84 g of raw white button mushrooms served cooked; 3) 168 g of raw white button mushrooms served cooked; 4) 84 g of raw yellow oyster mushrooms served cooked; or 5) 168 g of raw yellow oyster mushrooms served cooked. Between each run-in diet/testing period, participants will consume their usual, unrestricted self-selected diets for a minimum of 7 days.

Arm	Type	Receives
Control -- no mushrooms	Active comparator	Other: ControlSubjects will be randomized to consume a test day salad with 0 g, 84 g (yellow oyster or white button) or 168 g (yellow or white button) mushrooms. Mushrooms will be cooked prior to serving.
Yellow Oyster -- 84 g	Experimental	Other: Yellow Oyster -- 84 gSubjects will be randomized to consume a test day salad with 0 g, 84 g (yellow oyster or white button) or 168 g (yellow or white button) mushrooms. Mushrooms will be cooked prior to serving.
Yellow Oyster -- 168 g	Experimental	Other: Yellow Oyster -- 168 gSubjects will be randomized to consume a test day salad with 0 g, 84 g (yellow oyster or white button) or 168 g (yellow or white button) mushrooms. Mushrooms will be cooked prior to serving.
White button -- 84 g	Experimental	Other: White button -- 84 gSubjects will be randomized to consume a test day salad with 0 g, 84 g (yellow oyster or white button) or 168 g (yellow or white button) mushrooms. Mushrooms will be cooked prior to serving.
White button 168 g	Experimental	Other: White button -- 168 gSubjects will be randomized to consume a test day salad with 0 g, 84 g (yellow oyster or white button) or 168 g (yellow or white button) mushrooms. Mushrooms will be cooked prior to serving.

Who may qualify

Ages: 30 to 69 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Male or female;
age 30-69 y;
BMI: 25.0-34.9 kg/m2;
Not severely or extremely depressed (Beck's Depression Inventory score ≤30)
Total cholesterol <240 mg/dL, low-density lipoprotein cholesterol <160 mg/dL, triglycerides <400 mg/dL, fasting glucose <110 mg/dL;

Key exclusion criteria (11 listed)

BMI <25 or >35;
Severely depressed (Beck's Depression Inventory score >30);
Total cholesterol >240 mg/dL, low-density lipoprotein cholesterol >160 mg/dL, triglycerides >400 mg/dL, fasting glucose >110 mg/dL;
Body weight changes in previous 3 months (±3 kg);
Changes in physical activity regimen in the previous 3 months;

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
Yellow Oyster -- 84 gParticipants will consume the standardized test day salad plus 84 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served	Other	Yellow Oyster -- 84 g
Yellow Oyster -- 168 gParticipants will consume the standardized test day salad plus 168 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served	Other	Yellow Oyster -- 168 g
White button -- 84 gParticipants will consume the standardized test day salad plus 84 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served	Other	White button -- 84 g
White button -- 168 gParticipants will consume the standardized test day salad plus 168 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served	Other	White button 168 g
ControlParticipants will consume the standardized test day salad only	Other	Control -- no mushrooms

Primary outcome

Change in plasma glucose
Time frame: 5 hours
Plasma will be assessed for glucose values prior to salad consumption and in response to the test day meal
Change in plasma insulin
Time frame: 5 hours
Plasma will be assessed for insulin values prior to salad consumption and in response to the test day meal
Plasma metabolomics
Time frame: 5 hours
Plasma will be assessed for metabolomics (i.e. ergothioneine) via reverse phase liquid chromatography/mass spectrometry
Plasma ergothioneine
Time frame: 5 hours
Plasma will be assessed for ergothioneine concentration, a compound unique to mushrooms
Plasma triglycerides
Time frame: 5 hours
Plasma will be assessed for triglyceride values at the time of salad consumption and at each hour for 5 hours after salad consumption

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 16 Feb 2024.

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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.

Wayne Campbell, PhD principal investigator

Purdue University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Yellow Oyster -- 84 g, Yellow Oyster -- 168 g and White button -- 84 g in people with Diet, Healthy, run by Purdue University 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 14 inclusion and 11 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 16 Feb 2024. 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 plasma glucose (time frame: 5 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04257201.

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 16 Feb 2024.