Clinical trial NCT04257201: Mushroom Ingestion Study
Official title: Mushroom Ingestion Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Keywords: Mediterranean
Mushrooms
Metabolomics
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Mushroom Council
First posted: 2020-02-05
Enrollment: 7
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in plasma glucose
timeFrame: 5 hours
measure: Change in plasma insulin
timeFrame: 5 hours
measure: Plasma metabolomics
timeFrame: 5 hours
measure: Plasma ergothioneine
timeFrame: 5 hours
measure: Plasma triglycerides
timeFrame: 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References: