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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04257201
Other study ID # IRB-2019-645
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 15, 2020
Est. completion date May 21, 2021

Study information

Verified date February 2024
Source Purdue University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 compounds.


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.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date May 21, 2021
Est. primary completion date May 21, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 69 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Purdue University West Lafayette Indiana

Sponsors (2)

Lead Sponsor Collaborator
Purdue University Mushroom Council

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in plasma glucose Plasma will be assessed for glucose values prior to salad consumption and in response to the test day meal 5 hours
Primary Change in plasma insulin Plasma will be assessed for insulin values prior to salad consumption and in response to the test day meal 5 hours
Primary Plasma metabolomics Plasma will be assessed for metabolomics (i.e. ergothioneine) via reverse phase liquid chromatography/mass spectrometry 5 hours
Primary Plasma ergothioneine Plasma will be assessed for ergothioneine concentration, a compound unique to mushrooms 5 hours
Primary 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 5 hours
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