- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04257201
Mushroom Ingestion Study
February 15, 2024 updated by: Wayne Campbell, Purdue University
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 compounds.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jan Green
- Phone Number: 765-496-6342
- Email: jkgreen@purdue.edu
Study Contact Backup
- Name: Cassi Uffelman, BS
- Phone Number: 260-443-3052
- Email: cuffelma@purdue.edu
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47906
- Purdue University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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;
- Smoking;
- Diabetic;
- Acute illness;
- Pregnant or lactating;
- Allergic to mushrooms
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control -- no mushrooms
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.
|
Participants will consume the standardized test day salad only
|
Experimental: Yellow Oyster -- 84 g
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.
|
Participants will consume the standardized test day salad plus 84 g (raw weight) mushrooms.
Mushrooms will be cooked prior to being served
|
Experimental: Yellow Oyster -- 168 g
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.
|
Participants will consume the standardized test day salad plus 168 g (raw weight) mushrooms.
Mushrooms will be cooked prior to being served
|
Experimental: White button -- 84 g
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.
|
Participants will consume the standardized test day salad plus 84 g (raw weight) mushrooms.
Mushrooms will be cooked prior to being served
|
Experimental: White button 168 g
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.
|
Participants will consume the standardized test day salad plus 168 g (raw weight) mushrooms.
Mushrooms will be cooked prior to being served
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5 hours
|
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
|
5 hours
|
Plasma metabolomics
Time Frame: 5 hours
|
Plasma will be assessed for metabolomics (i.e.
ergothioneine) via reverse phase liquid chromatography/mass spectrometry
|
5 hours
|
Plasma ergothioneine
Time Frame: 5 hours
|
Plasma will be assessed for ergothioneine concentration, a compound unique to mushrooms
|
5 hours
|
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
|
5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Wayne Campbell, PhD, Purdue University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2020
Primary Completion (Actual)
May 21, 2021
Study Completion (Actual)
May 21, 2021
Study Registration Dates
First Submitted
December 18, 2019
First Submitted That Met QC Criteria
February 4, 2020
First Posted (Actual)
February 5, 2020
Study Record Updates
Last Update Posted (Actual)
February 16, 2024
Last Update Submitted That Met QC Criteria
February 15, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB-2019-645
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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