NCT01398176

Brief Summary

The purpose of this study is to determine whether consuming mushrooms is effective in enhancing the function of γδ T cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

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

First Submitted

Initial submission to the registry

July 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 30, 2013

Completed
Last Updated

December 30, 2013

Status Verified

December 1, 2013

Enrollment Period

7 months

First QC Date

July 18, 2011

Results QC Date

September 25, 2013

Last Update Submit

December 2, 2013

Conditions

Keywords

gamma delta T cellproliferation

Outcome Measures

Primary Outcomes (1)

  • Physiological Modifications to Gamma Delta T Cell Function

    Proliferation of γδ-T cells when cultured ex vivo in autologous serum. Values are expressed as a percent of CD3 cells, which means a percent of the total T cell population. Only T cells express CD3.

    4 weeks

Study Arms (2)

3 ounces of mushrooms

EXPERIMENTAL

3 ounces of mushrooms consumed daily for 4 weeks

Dietary Supplement: 3 ounces of mushrooms

6 ounces of mushrooms

EXPERIMENTAL

6 ounces of mushrooms consumed daily for 4 weeks

Dietary Supplement: 6 ounces of mushrooms

Interventions

3 ounces of mushroomsDIETARY_SUPPLEMENT

3 ounces of mushrooms consumed daily for 4 weeks

3 ounces of mushrooms
6 ounces of mushroomsDIETARY_SUPPLEMENT

6 ounces of mushrooms consumed daily for 4 weeks

6 ounces of mushrooms

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or non-pregnant female
  • Between the ages of 21 and 50
  • BMI between 18 and 35

You may not qualify if:

  • Have illness at the time of enrollment
  • On immunosuppressive drugs, antibiotics, chronic use of NSAIDS
  • Ongoing infection or hypertension that requires medication
  • Consume any flavonoid-containing supplements, antioxidant supplements or probiotics
  • Consume more than 14 glasses of alcoholic beverages per week
  • Consume more than 7 servings of fruits and vegetables per day
  • Are on a strict vegetarian diet
  • Pregnant or lactating women or individuals on hormone therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

449 Food Science and Human Nutrition Department

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

  • Dai X, Stanilka JM, Rowe CA, Esteves EA, Nieves C Jr, Spaiser SJ, Christman MC, Langkamp-Henken B, Percival SS. Consuming Lentinula edodes (Shiitake) Mushrooms Daily Improves Human Immunity: A Randomized Dietary Intervention in Healthy Young Adults. J Am Coll Nutr. 2015;34(6):478-87. doi: 10.1080/07315724.2014.950391. Epub 2015 Apr 11.

Limitations and Caveats

No specific limitations outside of the normal limitations to human interventions studies.

Results Point of Contact

Title
Dr. Susan S. Percival
Organization
UFlorida

Study Officials

  • Susan S Percival, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 20, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2012

Study Completion

December 1, 2012

Last Updated

December 30, 2013

Results First Posted

December 30, 2013

Record last verified: 2013-12

Locations