Immune Benefits From Mushroom Consumption
1 other identifier
interventional
52
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2011
CompletedFirst Posted
Study publicly available on registry
July 20, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
December 30, 2013
CompletedDecember 30, 2013
December 1, 2013
7 months
July 18, 2011
September 25, 2013
December 2, 2013
Conditions
Keywords
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
EXPERIMENTAL3 ounces of mushrooms consumed daily for 4 weeks
6 ounces of mushrooms
EXPERIMENTAL6 ounces of mushrooms consumed daily for 4 weeks
Interventions
3 ounces of mushrooms consumed daily for 4 weeks
6 ounces of mushrooms consumed daily for 4 weeks
Eligibility Criteria
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
- University of Floridalead
- Mushroom Councilcollaborator
Study Sites (1)
449 Food Science and Human Nutrition Department
Gainesville, Florida, 32611, United States
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.
PMID: 25866155DERIVED
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
- PRINCIPAL INVESTIGATOR
Susan S Percival, PhD
University of Florida
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