Mushroom Ingestion Study

Diet, Healthy Clinical Trial

Official title:

Mushroom Ingestion Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04257201
• Other study ID #: IRB-2019-645
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diet, Healthy

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