Postprandial Lipemia and Glycemia Following a High-Fat Meal

• Sponsor: State University of New York at Buffalo (Other)
• Overall Status: Completed
• CT.gov ID: NCT05619952
• Collaborator: (none)
• Enrollment: 16
• Arms: 3
• Actual Duration (Months): 89.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia; Postprandial Hyperglycemia; Lipid Disorder	Dietary Supplement: Mushroom Powder	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Double-blind, randomized
• Primary Purpose: Treatment
• Official Title: Acute Effects of White Button and Shiitake Mushroom Powder Supplementation on Postprandial Lipemia and Glycemia Following a High-Fat Meal
• Actual Study Start Date: Dec 29, 2014
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jun 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Postprandial Lipemia [Baseline, up to 6 hours postprandial]

   Total cholesterol, LDL, HDL, triglycerides

2. Postprandial Glycemia [Baseline, up to 6 hours postprandial]

   blood glucose

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• State University of New York at Buffalo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lillian A. Talal, Principal Investigator, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT05619952
• Other Study ID Numbers: 030-614292
• First Posted: Nov 17, 2022
• Last Update Posted: Nov 17, 2022
• Last Verified: Nov 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lillian A. Talal, Principal Investigator, State University of New York at Buffalo: mushroom; lipid metabolism; postprandial lipemia; postprandial glycemia
• Additional relevant MeSH terms: Hypercholesterolemia; Hyperglycemia; Hyperlipidemias; Lipid Metabolism Disorders

Study Results

No Results Posted as of Nov 17, 2022