The Effect of Aged Garlic Extract Supplementation on Immune System
1 other identifier
interventional
120
1 country
1
Brief Summary
The purpose of this study is to determine whether consuming capsules of aged garlic extract is effective in enhancing function of NK and/or γδ T cell resulting in fewer cold and flu symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2010
Shorter than P25 for not_applicable
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
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 5, 2011
CompletedFirst Posted
Study publicly available on registry
July 8, 2011
CompletedNovember 13, 2013
November 1, 2013
3 months
July 5, 2011
November 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physiological modifications to immune cell function
The ability of the natural killer and/or γδ T cells to proliferate when cultured ex vivo.
45 days
Secondary Outcomes (2)
Cold and flu symptoms
90 days
Cold and flu symptoms
90 days
Study Arms (2)
Sugar pill
PLACEBO COMPARATORlooks like and is given in the same way as the experimental treatment but contains no active ingredient
AGE
EXPERIMENTALEncapsulated aged garlic extract, 4 capsules per day, 2.56 g/day
Interventions
2 aged garlic extract capsules taken twice daily
encapsulated aged garlic extract, 4 capsules per day, 2.56g/day
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:
- High blood pressure defined as 140/90
- Ongoing or chronic illness or infection
- On hypertensive medication, immunosuppressive drugs, antibiotics, or chronic use of NSAIDS
- Taking dietary supplements other than those with "normal" levels of vitamins and minerals
- Consumes more than 2 glasses of alcoholic beverages per day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Wakunaga Pharmaceutical Co., Ltd.collaborator
Study Sites (1)
449 Food Science and Human Nutrition Department
Gainesville, Florida, 32611, United States
Related Publications (2)
Percival SS. Aged Garlic Extract Modifies Human Immunity. J Nutr. 2016 Feb;146(2):433S-436S. doi: 10.3945/jn.115.210427. Epub 2016 Jan 13.
PMID: 26764332DERIVEDNantz MP, Rowe CA, Muller CE, Creasy RA, Stanilka JM, Percival SS. Supplementation with aged garlic extract improves both NK and gammadelta-T cell function and reduces the severity of cold and flu symptoms: a randomized, double-blind, placebo-controlled nutrition intervention. Clin Nutr. 2012 Jun;31(3):337-44. doi: 10.1016/j.clnu.2011.11.019. Epub 2012 Jan 24.
PMID: 22280901DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Susan S Percival, PhD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2011
First Posted
July 8, 2011
Study Start
February 1, 2010
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
November 13, 2013
Record last verified: 2013-11