Postprandial Lipemia and Glycemia Following a High-Fat Meal

March 23, 2023 updated by: Lillian A. Talal, State University of New York at Buffalo

Acute Effects of White Button and Shiitake Mushroom Powder Supplementation on Postprandial Lipemia and Glycemia Following a High-Fat Meal

The goal of this clinical trial is to determine the acute effects on postprandial lipemia and glycemia by supplementing a high-fat meal with either white button (WB) or shiitake (SH) mushroom powder in relatively healthy adults, aged 18 to 35.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • generally healthy
  • non-diabetic
  • normal to mildly hypercholesterolemic (Total Cholesterol 200-239 mg/dL and LDL-C 130-159 mg/dL)
  • have BMI <30 or BF% (men <25%, women <32%)
  • no known disease of the liver or gallbladder
  • no documented problems with fat metabolism
  • normal lipemic response to a lipid challenge
  • No known mushroom allergy

Exclusion Criteria:

  • diabetic
  • pregnant
  • BMI >30
  • liver disease
  • gallbladder disease
  • mushroom allergy
  • lipid disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: White Button Mushroom
368.5 grams of irradiated ground beef patty (80/20 lean mass to fat ratio) + 14 grams white button mushroom powder, and a Wegmans Food Market Brand Big Hawaiian bun
Dietary supplement: Mushroom Powder
Ground shiitake mushrooms or ground white button mushrooms
Experimental: Shiitake Mushroom
368.5 grams of irradiated ground beef patty (80/20 lean mass to fat ratio) + 14 grams Shiitake mushroom powder, and a Wegmans Food Market Brand Big Hawaiian bun
Dietary supplement: Mushroom Powder
Ground shiitake mushrooms or ground white button mushrooms
No Intervention: Control
368.5 grams of irradiated ground beef patty (80/20 lean mass to fat ratio) and a Wegmans Food Market Brand Big Hawaiian bun.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial Lipemia
Time Frame: Baseline, up to 6 hours postprandial
Total cholesterol, LDL, HDL, triglycerides
Baseline, up to 6 hours postprandial
Postprandial Glycemia
Time Frame: Baseline, up to 6 hours postprandial
blood glucose
Baseline, up to 6 hours postprandial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Lillian A. Talal, Huipei Wang, Brian T. Wil-liams, Matthew J. Morris, Peter J. Horvath (2023) Acute Effects of White Button and Shiitake Mushroom Powder Supplementa-tion on Postprandial Lipemia and Glycemia Following a High-Fat Meal . International Journal of Nutrition - 7(2):42-56.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

November 9, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (Actual)

November 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 030-614292

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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