NCT05619952

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 29, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

1.5 years

First QC Date

November 9, 2022

Last Update Submit

March 23, 2023

Conditions

Keywords

mushroomlipid metabolismpostprandial lipemiapostprandial glycemia

Outcome Measures

Primary Outcomes (2)

  • Postprandial Lipemia

    Total cholesterol, LDL, HDL, triglycerides

    Baseline, up to 6 hours postprandial

  • Postprandial Glycemia

    blood glucose

    Baseline, up to 6 hours postprandial

Study Arms (3)

White Button Mushroom

EXPERIMENTAL

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

Shiitake Mushroom

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Mushroom PowderDIETARY_SUPPLEMENT

Ground shiitake mushrooms or ground white button mushrooms

Shiitake MushroomWhite Button Mushroom

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    RESULT

Related Links

MeSH Terms

Conditions

HypercholesterolemiaHyperglycemiaLipid Metabolism Disorders

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind, randomized
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 17, 2022

Study Start

December 29, 2014

Primary Completion

July 1, 2016

Study Completion

June 1, 2022

Last Updated

March 27, 2023

Record last verified: 2023-03