- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03352050
Mushroom Effects on Satiety and Gut Health Markers
January 22, 2018 updated by: University of Minnesota
The Investigator will compare the effect of mushrooms to ground beef in an intervention study and measure satiety markers and gut health markers
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Subjects will consume their habitual diet and the investigators will compare the acute effect of mushroom consumption on satiety and food intake.
Additionally, subjects will consume mushrooms for 10 days and the investigators will measure gut health markers, including short chain fatty acids, microbiota, and fecal weight.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Saint Paul, Minnesota, United States, 55108
- Department of Food Science and Nutrition
-
-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy
- Willing to consume mushrooms or ground beef for 10 days
Exclusion Criteria:
- Disease (chronic)
- Smoking,
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: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ground beef
ground beef instead of mushrooms
|
|
Active Comparator: Mushroom
2 servings of mushrooms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
satiety
Time Frame: Baseline
|
Measure satiety subjectively after consumption of breakfast with mushrooms
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gut health
Time Frame: 10 days
|
Measure stool weight and gut microbiota after consumption of mushrooms
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 1, 2015
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
June 21, 2017
First Submitted That Met QC Criteria
November 21, 2017
First Posted (Actual)
November 24, 2017
Study Record Updates
Last Update Posted (Actual)
January 24, 2018
Last Update Submitted That Met QC Criteria
January 22, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 1512M81224
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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