Mushroom Ingestion Study

NCT04257201 | Completed

• 1 other identifier: IRB-2019-645
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet, Healthy

Keywords

Mediterranean; Mushrooms; Metabolomics

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• Plasma metabolomics

  Plasma will be assessed for metabolomics (i.e. ergothioneine) via reverse phase liquid chromatography/mass spectrometry

  5 hours

• Plasma ergothioneine

  Plasma will be assessed for ergothioneine concentration, a compound unique to mushrooms

  5 hours

• 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

Study Arms (5)

Control -- no mushrooms

ACTIVE COMPARATOR

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

Yellow Oyster -- 84 g

EXPERIMENTAL

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

Yellow Oyster -- 168 g

EXPERIMENTAL

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

White button -- 84 g

EXPERIMENTAL

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

White button 168 g

EXPERIMENTAL

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

Interventions

Yellow Oyster -- 84 g OTHER

Participants will consume the standardized test day salad plus 84 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served

Yellow Oyster -- 84 g

Yellow Oyster -- 168 g OTHER

Participants will consume the standardized test day salad plus 168 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served

Yellow Oyster -- 168 g

White button -- 84 g OTHER

Participants will consume the standardized test day salad plus 84 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served

White button -- 84 g

White button -- 168 g OTHER

Participants will consume the standardized test day salad plus 168 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served

White button 168 g

Control OTHER

Participants will consume the standardized test day salad only

Control -- no mushrooms

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Purdue University: lead
• Mushroom Council: collaborator

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47906, United States

Location

Study Officials

• Wayne Campbell, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: February 5, 2020
• Study Start: August 15, 2020
• Primary Completion: May 21, 2021
• Study Completion: May 21, 2021
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

US (1)