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

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

Study Contact Backup

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.

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

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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