NCT03352050

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

2.4 years

First QC Date

June 21, 2017

Last Update Submit

January 22, 2018

Conditions

Diet Modification

Outcome Measures

Primary Outcomes (1)

  • satiety

    Measure satiety subjectively after consumption of breakfast with mushrooms

    Baseline

Secondary Outcomes (1)

  • Gut health

    10 days

Study Arms (2)

ground beef

ACTIVE COMPARATOR

ground beef instead of mushrooms

Other: ground beef

Mushroom

ACTIVE COMPARATOR

2 servings of mushrooms

Dietary Supplement: mushroom

Interventions

mushroomDIETARY_SUPPLEMENT
Mushroom
ground beefOTHER
ground beef

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Willing to consume mushrooms or ground beef for 10 days

You may not qualify if:

  • Disease (chronic)
  • Smoking,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food Science and Nutrition

Saint Paul, Minnesota, 55108, United States

Location

Study Officials

  • Joanne Slavin

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2017

First Posted

November 24, 2017

Study Start

July 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 24, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)