Diet ModificationNCT03352050
Mushroom Effects on Satiety and Gut Health Markers
A study testing mushroom and ground beef in people with Diet Modification, run by University of Minnesota at 1 site in United States.
Trial summary
The Investigator will compare the effect of mushrooms to ground beef in an intervention study and measure satiety markers and gut health markers Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Modification
- What is being tested?
- mushroom and ground beef
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2015to 1 Dec 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Willing to consume mushrooms or ground beef for 10 days
Who cannot join
- Disease (chronic)
- Smoking,
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Food Science and Nutrition
Saint Paul, Minnesota, 55108
About this study
The Investigator will compare the effect of mushrooms to ground beef in an intervention study and measure satiety markers and gut health markers
Read the 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.
- Conditions
- Diet Modification
- Being tested
- mushroom, ground beef
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mushroomDietary supplement
ground beefOther
| Study group | Role | What they receive |
|---|---|---|
| ground beef | Active comparator | ground beef instead of mushrooms Receives: Other: ground beef |
| Mushroom | Active comparator | 2 servings of mushrooms Receives: Dietary Supplement: mushroom |
What is being measured
The primary outcome is the main question the study is designed to answer.
satiety
Measure satiety subjectively after consumption of breakfast with mushrooms
Measured: Baseline
Secondary outcomes (1)
Gut health
Measure stool weight and gut microbiota after consumption of mushrooms
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Jul 2015
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne Slavin, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352050
- Sponsor's protocol ID
- 1512M81224
- Status last verified
- Jan 2018
- First submitted
- 21 Jun 2017
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mushroom Effects on Satiety and Gut Health Markers
- ClinicalTrials.gov ID
- NCT03352050
- Acronym / sponsor ID
- 1512M81224
- Conditions
- Diet Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 24 Nov 2017 (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 Investigator will compare the effect of mushrooms to ground beef in an intervention study and measure satiety markers and gut health markers
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ground beef | Active comparator | Other: ground beefground beef instead of mushrooms |
| Mushroom | Active comparator | Dietary Supplement: mushroom2 servings of mushrooms |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy
- Willing to consume mushrooms or ground beef for 10 days
Key exclusion criteria (2 listed)
- Disease (chronic)
- Smoking,
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 | Dietary supplement | Mushroom |
| ground beef | Other | ground beef |
Primary outcome
satiety
Time frame: Baseline
Measure satiety subjectively after consumption of breakfast with mushrooms
1 secondary outcome
Gut health
Time frame: 10 days
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 24 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Joanne Slavin principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mushroom and ground beef in people with Diet Modification, run by University of Minnesota at 1 site in United States.
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 2 inclusion and 2 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 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
satiety (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2018.