Trial Outcomes & Findings for Immune Benefits From Mushroom Consumption (NCT NCT01398176)

NCT ID: NCT01398176

Last Updated: 2013-12-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2013-12-30

Participant Flow

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.

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.

Participant milestones

Measure	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
Overall Study STARTED	26	25
Overall Study COMPLETED	23	19
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Measure	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
Overall Study Lost to Follow-up	1	3
Overall Study Physician Decision	2	3

Baseline Characteristics

Immune Benefits From Mushroom Consumption

Baseline characteristics by cohort

Measure	3 Ounces of Mushrooms n=26 Participants 3 ounces of mushrooms consumed daily for 4 weeks	6 Ounces of Mushrooms n=25 Participants 6 ounces of mushrooms consumed daily for 4 weeks	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	22.8 years STANDARD_DEVIATION 2.14 • n=5 Participants	25.6 years STANDARD_DEVIATION 6.4 • n=7 Participants	24.2 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	25 participants n=7 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Intent to treat

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.

Outcome measures

Measure	3 Ounces of Mushrooms n=26 Participants 3 ounces of mushrooms consumed daily for 4 weeks	6 Ounces of Mushrooms n=25 Participants 6 ounces of mushrooms consumed daily for 4 weeks
Physiological Modifications to Gamma Delta T Cell Function	22.65 percent of T lymphocytes Standard Error 0.97	22.17 percent of T lymphocytes Standard Error 1.01

Adverse Events

3 Ounces of Mushrooms

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

6 Ounces of Mushrooms

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Susan S. Percival

UFlorida

Phone: 352-392-1991

Email: percival@ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place