Mushroom Ingestion Study

Sponsor

Purdue University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04257201

Collaborator

Mushroom Council (Other)

Enrollment

Location

Arms

27.5

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diet, Healthy	Other: Yellow Oyster -- 84 g Other: Yellow Oyster -- 168 g Other: White button -- 84 g Other: White button -- 168 g Other: Control	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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 (Investigator)

Primary Purpose:

Other

Official Title:

Mushroom Ingestion Study

Actual Study Start Date :

Aug 15, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.	Other: Control 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.	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
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.	Other: 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
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.	Other: 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
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.	Other: 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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Purdue University	West Lafayette	Indiana	United States	47906

Sponsors and Collaborators

Purdue University
Mushroom Council

Investigators

Principal Investigator: Wayne Campbell, PhD, Purdue University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wayne Campbell, Principal Investigator, Purdue University

ClinicalTrials.gov Identifier:

NCT04257201

Other Study ID Numbers:

IRB-2019-645

First Posted:

Feb 5, 2020

Last Update Posted:

Oct 18, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wayne Campbell, Principal Investigator, Purdue University

Mediterranean

Mushrooms

Metabolomics

Study Results

No Results Posted as of Oct 18, 2021