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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
3 Ounces of Mushrooms 3 ounces of mushrooms consumed daily for 4 weeks
6 Ounces of Mushrooms 6 ounces of mushrooms consumed daily for 4 weeks

Participant Flow:   Overall Study
    3 Ounces of Mushrooms   6 Ounces of Mushrooms
STARTED   26   25 
COMPLETED   23   19 
NOT COMPLETED   3   6 
Lost to Follow-up                1                3 
Physician Decision                2                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
3 Ounces of Mushrooms 3 ounces of mushrooms consumed daily for 4 weeks
6 Ounces of Mushrooms 6 ounces of mushrooms consumed daily for 4 weeks
Total Total of all reporting groups

Baseline Measures
   3 Ounces of Mushrooms   6 Ounces of Mushrooms   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 26   25   51 
Age 
[Units: Participants]
 		     
<=18 years   0   0   0 
Between 18 and 65 years   26   25   51 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 22.8  (2.14)   25.6  (6.4)   24.2  (4.9) 
Gender 
[Units: Participants]
 		     
Female   16   16   32 
Male   10   9   19 
Region of Enrollment 
[Units: Participants]
 		     
United States   26   25   51 


  Outcome Measures

1.  Primary:   Physiological Modifications to Gamma Delta T Cell Function   [ Time Frame: 4 weeks ]
  Show Outcome Measure 1


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No specific limitations outside of the normal limitations to human interventions studies.


  More Information

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:  
Name/Title: Dr. Susan S. Percival
Organization: UFlorida
phone: 352-392-1991 ext 201
e-mail: percival@ufl.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


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