Mushroom Effects on Satiety and Gut Health Markers | NCT03352050

Studies
Mushroom Effects on Satiety and Gut Health Markers

NCT03352050

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Jan 24, 2018Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Diet Modification

Interventions

mushroom
ground beef

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2015Actual

Primary Completion Date

Dec 1, 2017Actual

Completion Date

Dec 1, 2017Actual

First Submitted Date

Jun 21, 2017

First Submission Date that Met QC Criteria

Nov 21, 2017

First Posted Date

Nov 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2018

Last Update Posted Date

Jan 24, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ground beef	Active Comparator	ground beef instead of mushrooms	Other: ground beef
Mushroom	Active Comparator	2 servings of mushrooms	Dietary Supplement: mushroom

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mushroom	Dietary Supplement		Mushroom
ground beef

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
satiety	Measure satiety subjectively after consumption of breakfast with mushrooms	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Gut health	Measure stool weight and gut microbiota after consumption of mushrooms	10 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy
Willing to consume mushrooms or ground beef for 10 days

Exclusion Criteria:

Disease (chronic)
Smoking,

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joanne Slavin	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Food Science and Nutrition		Saint Paul	Minnesota	55108	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided