Immune Benefits From Mushroom Consumption

This study has been completed.
Sponsor:
Collaborator:
The Mushroom Council
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01398176
First received: July 18, 2011
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Healthy Humans
Dietary Supplement: 3 ounces of mushrooms
Dietary Supplement: 6 ounces of mushrooms

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Immune Benefits From Mushroom Consumption

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Physiological Modifications to Gamma Delta T Cell Function [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 52
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3 ounces of mushrooms
3 ounces of mushrooms consumed daily for 4 weeks
Dietary Supplement: 3 ounces of mushrooms
3 ounces of mushrooms consumed daily for 4 weeks
Experimental: 6 ounces of mushrooms
6 ounces of mushrooms consumed daily for 4 weeks
Dietary Supplement: 6 ounces of mushrooms
6 ounces of mushrooms consumed daily for 4 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398176

Locations
United States, Florida
449 Food Science and Human Nutrition Department
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
The Mushroom Council
Investigators
Principal Investigator: Susan S Percival, PhD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01398176     History of Changes
Other Study ID Numbers: MC-95320
Study First Received: July 18, 2011
Results First Received: September 25, 2013
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
gamma delta T cell
proliferation

ClinicalTrials.gov processed this record on April 16, 2014