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OpenTrials
Completed

NCT Number: NCT04257201

Mushroom Ingestion Study

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.

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Key information

Conditions

Age range

30 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 -- 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 -- 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 -- 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

Control

Other

Participants will consume the standardized test day salad only

Primary outcomes

  1. Change in plasma glucose

    Time frame: 5 hours

    Plasma will be assessed for glucose values prior to salad consumption and in response to the test day meal

  2. Change in plasma insulin

    Time frame: 5 hours

    Plasma will be assessed for insulin values prior to salad consumption and in response to the test day meal

  3. Plasma metabolomics

    Time frame: 5 hours

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

  4. Plasma ergothioneine

    Time frame: 5 hours

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

  5. Plasma triglycerides

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Mushroom Council

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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