Immune Benefits From Mushroom Consumption
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| ClinicalTrials.gov Identifier: NCT01398176 |
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Recruitment Status :
Completed
First Posted : July 20, 2011
Results First Posted : December 30, 2013
Last Update Posted : December 30, 2013
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Sponsor:
University of Florida
Collaborator:
Mushroom Council
Information provided by (Responsible Party):
University of Florida
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| 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 |
Participant Flow
| 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 |
|---|---|---|
 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 |
Baseline Characteristics
| Arm/Group Title | 3 Ounces of Mushrooms | 6 Ounces of Mushrooms | Total | |
|---|---|---|---|---|
|
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 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 26 participants | 25 participants | 51 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
26 100.0%
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25 100.0%
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51 100.0%
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| >=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 26 participants | 25 participants | 51 participants | |
| 22.8 (2.14) | 25.6 (6.4) | 24.2 (4.9) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 26 participants | 25 participants | 51 participants | |
| Female |
16 61.5%
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16 64.0%
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32 62.7%
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| Male |
10 38.5%
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9 36.0%
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19 37.3%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 26 participants | 25 participants | 51 participants |
| 26 | 25 | 51 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
No specific limitations outside of the normal limitations to human interventions studies.
More Information
Results Point of Contact
| 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):
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT01398176 |
| 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 |