Improvement in Immune Cell Function in Healthy HumansNCT01390116
The Effect of Aged Garlic Extract Supplementation on Immune System
A study testing Aged garlic extract and AGE in people with Improvement in Immune Cell Function in Healthy Humans, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Improvement in Immune Cell Function in Healthy Humans
- What is being tested?
- Aged garlic extract and AGE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or non-pregnant female
- Between the ages of 21 and 50
- BMI between 18 and 35
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
449 Food Science and Human Nutrition Department
Gainesville, Florida, 32611
About this study
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.
Read the detailed description
A non-therapeutic intervention study is described. The Aged Garlic Extract (AGE) supplement (and placebo) intervention occurs over a total of 90 days between mid-January to March. The CDC indicates that this is the cold and flu season (http://www.cdc.gov/flu/weekly/fluactivity.htm ). Blood is taken at baseline and at 45 days, 2 hours after they have taken their capsule. Capsule consumption will continue for a total of 90 days in order to continue monitoring cold and flu symptoms. Subjects will be given a diary to keep a record of their cold and flu symptoms. Peripheral blood mononuclear cells are isolated from the blood draw and used fresh, cultured in autologous serum for 24 hours or cultured in autologous serum for 10 days. Freshly isolated cells will be used for glutathione analysis, for protection against induced DNA strand breaks, and for γδ T cell and NK cell numbers. The supernatant of 24 hour cultures will be used for cytokine determination, specifically, interferon-g, tumor necrosis factor-a and IL-12. Cells cultured for 10 days will be used to determine the rate of proliferation. If cells have been primed by AGE, we expect the AGE cells to proliferate to a greater extent and have greater cytokine secretion compared to placebo.
If AGE enhances the function of one or both of these cell types (NK or γδ T cell), then it is possible that there will be fewer cold and flu symptoms in the group consuming the supplement.
- Being tested
- Aged garlic extract, AGE
- Keywords
- gamma delta T cell, natural killer cell, proliferation, cytokine secretion, Improvement in immune cell function in healthy humans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aged garlic extractDietary supplement
Also called AGE
2 aged garlic extract capsules taken twice daily
AGEDietary supplement
Also called Kyolic
encapsulated aged garlic extract, 4 capsules per day, 2.56g/day
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | looks like and is given in the same way as the experimental treatment but contains no active ingredient Receives: Dietary Supplement: Aged garlic extract |
| AGE | Experimental | Encapsulated aged garlic extract, 4 capsules per day, 2.56 g/day Receives: Dietary Supplement: AGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological modifications to immune cell function
The ability of the natural killer and/or γδ T cells to proliferate when cultured ex vivo.
Measured: 45 days
Secondary outcomes (2)
Cold and flu symptoms
Incidence and severity of cold and flu symptoms, total and individual. Other signs of severity, for example, visits to doctor or health clinic, reduction in daily activities, medications prescribed or purchased OTC.
Measured: 90 days
Cold and flu symptoms
Incidence and severity of cold and flu symptoms, total and individual. Other signs of severity, for example, visits to doctor or health clinic, reduction in daily activities, medications prescribed or purchased Over the Counter (OTC).
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Improvement in Immune Cell Function in Healthy HumansStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Susan S Percival, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390116
- Sponsor's protocol ID
- AGE-84403
- Status last verified
- Nov 2013
- First submitted
- 5 Jul 2011
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26764332Nantz 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.
PubMed 22280901
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aged Garlic Extract Supplementation on Immune System
- ClinicalTrials.gov ID
- NCT01390116
- Acronym / sponsor ID
- AGE-84403
- Keywords
- gamma delta T cell, natural killer cell, proliferation, cytokine secretion, Improvement in immune cell function in healthy humans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd.
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A non-therapeutic intervention study is described. The Aged Garlic Extract (AGE) supplement (and placebo) intervention occurs over a total of 90 days between mid-January to March. The CDC indicates that this is the cold and flu season (http://www.cdc.gov/flu/weekly/fluactivity.htm ). Blood is taken at baseline and at 45 days, 2 hours after they have taken their capsule. Capsule consumption will continue for a total of 90 days in order to continue monitoring cold and flu symptoms. Subjects will be given a diary to keep a record of their cold and flu symptoms. Peripheral blood mononuclear cells are isolated from the blood draw and used fresh, cultured in autologous serum for 24 hours or cultured in autologous serum for 10 days. Freshly isolated cells will be used for glutathione analysis, for protection against induced DNA strand breaks, and for γδ T cell and NK cell numbers. The supernatant of 24 hour cultures will be used for cytokine determination, specifically, interferon-g, tumor necrosis factor-a and IL-12. Cells cultured for 10 days will be used to determine the rate of proliferation. If cells have been primed by AGE, we expect the AGE cells to proliferate to a greater extent and have greater cytokine secretion compared to placebo.
If AGE enhances the function of one or both of these cell types (NK or γδ T cell), then it is possible that there will be fewer cold and flu symptoms in the group consuming the supplement.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Dietary Supplement: Aged garlic extractlooks like and is given in the same way as the experimental treatment but contains no active ingredient |
| AGE | Experimental | Dietary Supplement: AGEEncapsulated aged garlic extract, 4 capsules per day, 2.56 g/day |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or non-pregnant female
- Between the ages of 21 and 50
- BMI between 18 and 35
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aged garlic extractAlso: AGE2 aged garlic extract capsules taken twice daily | Dietary supplement | Sugar pill |
| AGEAlso: Kyolicencapsulated aged garlic extract, 4 capsules per day, 2.56g/day | Dietary supplement | AGE |
Primary outcome
Physiological modifications to immune cell function
Time frame: 45 days
The ability of the natural killer and/or γδ T cells to proliferate when cultured ex vivo.
2 secondary outcomes
Cold and flu symptoms
Time frame: 90 days
Cold and flu symptoms
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
- Derived from this study: PubMed 26764332Percival 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.
- Derived from this study: PubMed 22280901Nantz 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan S Percival, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aged garlic extract and AGE in people with Improvement in Immune Cell Function in Healthy Humans, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological modifications to immune cell function (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01390116, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.