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Postprandial Lipemia and Glycemia Following a High-Fat Meal

Primary Purpose

Hypercholesterolemia, Postprandial Hyperglycemia, Lipid Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mushroom Powder
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring mushroom, lipid metabolism, postprandial lipemia, postprandial glycemia

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    White Button Mushroom

    Shiitake Mushroom

    Control

    Arm Description

    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

    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

    368.5 grams of irradiated ground beef patty (80/20 lean mass to fat ratio) and a Wegmans Food Market Brand Big Hawaiian bun.

    Outcomes

    Primary Outcome Measures

    Postprandial Lipemia
    Total cholesterol, LDL, HDL, triglycerides
    Postprandial Glycemia
    blood glucose

    Secondary Outcome Measures

    Full Information

    First Posted
    November 9, 2022
    Last Updated
    March 23, 2023
    Sponsor
    State University of New York at Buffalo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05619952
    Brief Title
    Postprandial Lipemia and Glycemia Following a High-Fat Meal
    Official Title
    Acute Effects of White Button and Shiitake Mushroom Powder Supplementation on Postprandial Lipemia and Glycemia Following a High-Fat Meal
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    December 29, 2014 (Actual)
    Primary Completion Date
    July 1, 2016 (Actual)
    Study Completion Date
    June 1, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    State University of New York at Buffalo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia, Postprandial Hyperglycemia, Lipid Disorder
    Keywords
    mushroom, lipid metabolism, postprandial lipemia, postprandial glycemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    Double-blind, randomized
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    White Button Mushroom
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Shiitake Mushroom
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    368.5 grams of irradiated ground beef patty (80/20 lean mass to fat ratio) and a Wegmans Food Market Brand Big Hawaiian bun.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Mushroom Powder
    Intervention Description
    Ground shiitake mushrooms or ground white button mushrooms
    Primary Outcome Measure Information:
    Title
    Postprandial Lipemia
    Description
    Total cholesterol, LDL, HDL, triglycerides
    Time Frame
    Baseline, up to 6 hours postprandial
    Title
    Postprandial Glycemia
    Description
    blood glucose
    Time Frame
    Baseline, up to 6 hours postprandial

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    Citation
    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.
    Results Reference
    result
    Links:
    URL
    https://doi.org/10.14302/issn.2379-7835.ijn-23-4430
    Description
    Related Info

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    Postprandial Lipemia and Glycemia Following a High-Fat Meal

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