Immune Benefits From Mushroom Consumption

This study has been completed.
Sponsor:
Collaborator:
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 October 02, 2014