HypercholesterolemiaNCT05619952
Postprandial Lipemia and Glycemia Following a High-Fat Meal
A study testing Mushroom Powder in people with Hypercholesterolemia and Postprandial Hyperglycemia, run by State University of New York at Buffalo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Postprandial Hyperglycemia, Lipid Disorder
- What is being tested?
- Mushroom Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 29 Dec 2014to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- diabetic
- pregnant
- BMI >30
- liver disease
- gallbladder disease
- mushroom allergy
- lipid disorder
About this study
Official title: 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.
- Being tested
- Mushroom Powder
- Keywords
- mushroom, lipid metabolism, postprandial lipemia, postprandial glycemia
- Medical subject headings
- Hypercholesterolemia, Hyperglycemia, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mushroom PowderDietary supplement
Ground shiitake mushrooms or ground white button mushrooms
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Lipemia
Total cholesterol, LDL, HDL, triglycerides
Measured: Baseline, up to 6 hours postprandial
Postprandial Glycemia
blood glucose
Measured: Baseline, up to 6 hours postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start29 Dec 2014
- Primary completion1 Jul 2016
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lillian A. Talal, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619952
- Sponsor's protocol ID
- 030-614292
- Status last verified
- Mar 2023
- First submitted
- 9 Nov 2022
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of White Button and Shiitake Mushroom Powder Supplementation on Postprandial Lipemia and Glycemia Following a High-Fat Meal
- ClinicalTrials.gov ID
- NCT05619952
- Acronym / sponsor ID
- 030-614292
- Keywords
- mushroom, lipid metabolism, postprandial lipemia, postprandial glycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 29 Dec 2014 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| White Button Mushroom | Experimental | Dietary Supplement: Mushroom Powder368.5 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 |
| Shiitake Mushroom | Experimental | Dietary Supplement: Mushroom Powder368.5 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 |
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- diabetic
- pregnant
- BMI >30
- liver disease
- gallbladder disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mushroom PowderGround shiitake mushrooms or ground white button mushrooms | Dietary supplement | Shiitake Mushroom, White Button Mushroom |
Primary outcome
Postprandial Lipemia
Time frame: Baseline, up to 6 hours postprandial
Total cholesterol, LDL, HDL, triglycerides
Postprandial Glycemia
Time frame: Baseline, up to 6 hours postprandial
blood glucose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Results publicationLillian 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mushroom Powder in people with Hypercholesterolemia and Postprandial Hyperglycemia, run by State University of New York at Buffalo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial Lipemia (time frame: Baseline, up to 6 hours postprandial). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05619952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.