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Immune Benefits From Mushroom Consumption

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ClinicalTrials.gov Identifier: NCT01398176
Recruitment Status : Completed
First Posted : July 20, 2011
Results First Posted : December 30, 2013
Last Update Posted : December 30, 2013
Sponsor:
Collaborator:
Mushroom Council
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Humans
Interventions Dietary Supplement: 3 ounces of mushrooms
Dietary Supplement: 6 ounces of mushrooms
Enrollment 52
Recruitment Details Recruitment took place in October 2011. Individuals responded to posted advertisements by calling. Eligibility was determined and the individual was assigned a time to come in for the first blood draw.
Pre-assignment Details 52 participants were consented to the study; however, one participant who was consented was found to be in a conflicting study, and was dropped prior to the start of the study. 51 participants started the study interventions.
Arm/Group Title 3 Ounces of Mushrooms 6 Ounces of Mushrooms
Hide Arm/Group Description 3 ounces of mushrooms consumed daily for 4 weeks 6 ounces of mushrooms consumed daily for 4 weeks
Period Title: Overall Study
Started 26 25
Completed 23 19
Not Completed 3 6
Reason Not Completed
Lost to Follow-up             1             3
Physician Decision             2             3
Arm/Group Title 3 Ounces of Mushrooms 6 Ounces of Mushrooms Total
Hide Arm/Group Description 3 ounces of mushrooms consumed daily for 4 weeks 6 ounces of mushrooms consumed daily for 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 26 25 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 25 participants 51 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
 100.0%
25
 100.0%
51
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 25 participants 51 participants
22.8  (2.14) 25.6  (6.4) 24.2  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 25 participants 51 participants
Female
16
  61.5%
16
  64.0%
32
  62.7%
Male
10
  38.5%
9
  36.0%
19
  37.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 25 participants 51 participants
26 25 51
1.Primary Outcome
Title Physiological Modifications to Gamma Delta T Cell Function
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title 3 Ounces of Mushrooms 6 Ounces of Mushrooms
Hide Arm/Group Description:
3 ounces of mushrooms consumed daily for 4 weeks
6 ounces of mushrooms consumed daily for 4 weeks
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: percent of T lymphocytes
22.65  (0.97) 22.17  (1.01)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 3 Ounces of Mushrooms 6 Ounces of Mushrooms
Hide Arm/Group Description 3 ounces of mushrooms consumed daily for 4 weeks 6 ounces of mushrooms consumed daily for 4 weeks
All-Cause Mortality
3 Ounces of Mushrooms 6 Ounces of Mushrooms
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
3 Ounces of Mushrooms 6 Ounces of Mushrooms
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
3 Ounces of Mushrooms 6 Ounces of Mushrooms
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/25 (0.00%) 
No specific limitations outside of the normal limitations to human interventions studies.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Susan S. Percival
Organization: UFlorida
Phone: 352-392-1991 ext 201
EMail: percival@ufl.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01398176     History of Changes
Other Study ID Numbers: MC-95320
First Submitted: July 18, 2011
First Posted: July 20, 2011
Results First Submitted: September 25, 2013
Results First Posted: December 30, 2013
Last Update Posted: December 30, 2013