HealthyEAGESIS IINCT01959646
The Effect of AGE on the Immune System
A study testing Aged Garlic Extract Supplementation Group and Standard for Groups in people with Healthy, run by University of Florida at 2 sites in United States.
Trial summary
This is a nutritional intervention study using healthy overweight/obese humans to investigate if a supplement made from aged garlic extract has an impact on immunity. Following a baseline blood draw, participants will consume the capsules (garlic or placebo) for 42 days, at which time a second blood draw will occur. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aged Garlic Extract Supplementation Group and Standard for Groups
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to Nov 2015
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ages 25-65
- BMI > or = to 30 kg/m2
- willing to discontinue dietary supplements
- cRP between 2 and 10 mg/L
Who cannot join
- medication for hypertension, high cholesterol, heart failure, angina, etc
- diagnoses of diabetes, metabolic syndrome, arthritis, severe allergies, or any other compromised immune condition
- blood pressure > 135/85 mmHg
- serum triglycerides > 150 mg/dl
- HDL cholesterol < 40 mg/dl for men or < 50 mg/dl for women
- fasting glucose > 110 mg/dl
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Food Science & Human Nutrition Building, University of Florida
Gainesville, Florida, 32611
University of Florida
Gainesville, Florida, 32611
About this study
Official title: The Effect of Aged Garlic Extract Supplementation on the Immune System
This is a nutritional intervention study using healthy overweight/obese humans to investigate if a supplement made from aged garlic extract has an impact on immunity. Following a baseline blood draw, participants will consume the capsules (garlic or placebo) for 42 days, at which time a second blood draw will occur. Tests for immune function and inflammation will be performed on both the baseline and 42 day samples. The investigators anticipate that the immune functions and biomarkers that are inflammatory in an overweight/obese population will be returning to normal after 42 days of consumption of this supplement. The investigators predict that AGE supplementation will benefit immunity and improve function while reducing inflammation in a stressed population (inflamed obese).
Read the detailed description
Healthy, overweight adults age 25 to 65 will be recruited, consented and screened for eligibility. To assess for eligible study participants, the investigators will use the Cholestech LDX® System (Alere™ Inc, Waltham, MA) to analyze finger-prick blood samples. This is an efficient and economical point of care testing for c-Reactive Protein (CRP), cholesterol and related lipids, and blood glucose, as diagnostic tools which provide information for immediate risk assessment and therapeutic monitoring of heart disease, inflammatory disorders and diabetes. Each finger prick will be treated individually. To this end, universal precautions such as hand washing, glove change, new lancet, etc. will be utilized for every finger prick throughout the assessment.
Eligible participants will be enrolled, and subsequently return, to provide a baseline blood draw, and given their random group assignment. Participants will be asked to consume three (3) capsules of 600 mg AGE or placebo with food twice a day, for a total of 3.6 grams per day. This dose was determined from previous studies that analyzed for cardiovascular risk factors. The supplementation (AGE and placebo) intervention will occur over 42 days, sometime between September 2013 and February 2013. Blood will be taken again at 42 days, two (2) hours after subjects have taken their capsules. A light breakfast will be offered after both fasting blood draws.
Peripheral blood mononuclear cells will be isolated from the blood at both blood draws and either used fresh, or cultured in autologous serum for 24 hours. Freshly isolated cells will be used to determine compliance (glutathione); population numbers of γδ T cells and monocytes and their function (activation); and mRNA expression of IL-6 and TNF-α. After 24 hours of stimulation with a broad based mitogen, culture medium will be harvested and assayed for IL-6, and TNF-α proteins. The cultured cells will be assayed for γδ T cell and monocyte function and for mRNA analysis of IL-6 and TNF-α gene expression. The serum obtained at both blood draws will be used in cultures as autologous serum and for assay of inflammatory biomarkers (C-reactive protein, IL-6, TNF-α, adiponectin and leptin). Compliance will also be determined by capsule count.
- Conditions
- Healthy
- Being tested
- Aged Garlic Extract Supplementation Group, Standard for Groups, Placebo
- Keywords
- Immune Function, Aged Garlic Extract, Supplementation, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aged Garlic Extract Supplementation GroupDietary supplement
Also called AGE
Subjects will be asked to consume three (3) capsules of 600 mg aged garlic extract (AGE) with food twice a day, for a total of 3.6 grams per day.
Standard for GroupsOther
To assess for eligible study participants, the research team will use the Cholestech LDX® System (Alere™ Inc, Waltham, MA) to analyze finger-prick blood samples. This is an efficient and economical point of care testing for c-Reactive Protein (CRP), cholesterol and related lipids, and blood glucose, as diagnostic tools which provide information for immediate risk assessment and therapeutic monitoring of heart disease, inflammatory disorders and diabetes. Each finger prick will be treated individually.
PlaceboDietary supplement
Participants will be asked to consume three (3) placebo capsules with food twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Group Receives: Other: Standard for Groups; Dietary Supplement: Placebo |
| Aged Garlic Extract Supplementation | Experimental | Aged Garlic Extract Supplementation Group Receives: Dietary Supplement: Aged Garlic Extract Supplementation Group; Other: Standard for Groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of immune health
Number and function of gamma delta T-cells and monocytes
Measured: 6 weeks
Secondary outcomes (1)
Markers of inflammation
IL-6 and TNF alpha
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Percival, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959646
- Sponsor's protocol ID
- IRB201300529
- Acronym
- EAGESIS II
- Status last verified
- Feb 2016
- First submitted
- 8 Oct 2013
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Xu C, Mathews AE, Rodrigues C, Eudy BJ, Rowe CA, O'Donoughue A, Percival SS. Aged garlic extract supplementation modifies inflammation and immunity of adults with obesity: A randomized, double-blind, placebo-controlled clinical trial. Clin Nutr ESPEN. 2018 Apr;24:148-155. doi: 10.1016/j.clnesp.2017.11.010. Epub 2018 Jan 3.
PubMed 29576354
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aged Garlic Extract Supplementation on the Immune System
- ClinicalTrials.gov ID
- NCT01959646
- Acronym / sponsor ID
- EAGESIS II / IRB201300529
- Conditions
- Healthy
- Keywords
- Immune Function, Aged Garlic Extract, Supplementation, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 10 Oct 2013 (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.
This is a nutritional intervention study using healthy overweight/obese humans to investigate if a supplement made from aged garlic extract has an impact on immunity. Following a baseline blood draw, participants will consume the capsules (garlic or placebo) for 42 days, at which time a second blood draw will occur. Tests for immune function and inflammation will be performed on both the baseline and 42 day samples. The investigators anticipate that the immune functions and biomarkers that are inflammatory in an overweight/obese population will be returning to normal after 42 days of consumption of this supplement. The investigators predict that AGE supplementation will benefit immunity and improve function while reducing inflammation in a stressed population (inflamed obese).
Detailed description
Healthy, overweight adults age 25 to 65 will be recruited, consented and screened for eligibility. To assess for eligible study participants, the investigators will use the Cholestech LDX® System (Alere™ Inc, Waltham, MA) to analyze finger-prick blood samples. This is an efficient and economical point of care testing for c-Reactive Protein (CRP), cholesterol and related lipids, and blood glucose, as diagnostic tools which provide information for immediate risk assessment and therapeutic monitoring of heart disease, inflammatory disorders and diabetes. Each finger prick will be treated individually. To this end, universal precautions such as hand washing, glove change, new lancet, etc. will be utilized for every finger prick throughout the assessment.
Eligible participants will be enrolled, and subsequently return, to provide a baseline blood draw, and given their random group assignment. Participants will be asked to consume three (3) capsules of 600 mg AGE or placebo with food twice a day, for a total of 3.6 grams per day. This dose was determined from previous studies that analyzed for cardiovascular risk factors. The supplementation (AGE and placebo) intervention will occur over 42 days, sometime between September 2013 and February 2013. Blood will be taken again at 42 days, two (2) hours after subjects have taken their capsules. A light breakfast will be offered after both fasting blood draws.
Peripheral blood mononuclear cells will be isolated from the blood at both blood draws and either used fresh, or cultured in autologous serum for 24 hours. Freshly isolated cells will be used to determine compliance (glutathione); population numbers of γδ T cells and monocytes and their function (activation); and mRNA expression of IL-6 and TNF-α. After 24 hours of stimulation with a broad based mitogen, culture medium will be harvested and assayed for IL-6, and TNF-α proteins. The cultured cells will be assayed for γδ T cell and monocyte function and for mRNA analysis of IL-6 and TNF-α gene expression. The serum obtained at both blood draws will be used in cultures as autologous serum and for assay of inflammatory biomarkers (C-reactive protein, IL-6, TNF-α, adiponectin and leptin). Compliance will also be determined by capsule count.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Standard for Groups, Dietary Supplement: PlaceboPlacebo Group |
| Aged Garlic Extract Supplementation | Experimental | Dietary Supplement: Aged Garlic Extract Supplementation Group, Other: Standard for GroupsAged Garlic Extract Supplementation Group |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ages 25-65
- BMI > or = to 30 kg/m2
- willing to discontinue dietary supplements
- cRP between 2 and 10 mg/L
Key exclusion criteria (6 listed)
- medication for hypertension, high cholesterol, heart failure, angina, etc
- diagnoses of diabetes, metabolic syndrome, arthritis, severe allergies, or any other compromised immune condition
- blood pressure > 135/85 mmHg
- serum triglycerides > 150 mg/dl
- HDL cholesterol < 40 mg/dl for men or < 50 mg/dl for women
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 Extract Supplementation GroupAlso: AGESubjects will be asked to consume three (3) capsules of 600 mg aged garlic extract (AGE) with food twice a day, for a total of 3.6 grams per day. | Dietary supplement | Aged Garlic Extract Supplementation |
| Standard for GroupsTo assess for eligible study participants, the research team will use the Cholestech LDX® System (Alere™ Inc, Waltham, MA) to analyze finger-prick blood samples. This is an efficient and economical point of care testing for c-Reactive Protein (CRP), cholesterol and related lipids, and blood glucose, as diagnostic tools which provide information for immediate risk assessment and therapeutic monitoring of heart disease, inflammatory disorders and diabetes. Each finger prick will be treated individually. | Other | Aged Garlic Extract Supplementation, Placebo |
| PlaceboParticipants will be asked to consume three (3) placebo capsules with food twice a day. | Dietary supplement | Placebo |
Primary outcome
Markers of immune health
Time frame: 6 weeks
Number and function of gamma delta T-cells and monocytes
1 secondary outcome
Markers of inflammation
Time frame: 6 weeks
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 26 Feb 2016.
- Derived from this study: PubMed 29576354Xu C, Mathews AE, Rodrigues C, Eudy BJ, Rowe CA, O'Donoughue A, Percival SS. Aged garlic extract supplementation modifies inflammation and immunity of adults with obesity: A randomized, double-blind, placebo-controlled clinical trial. Clin Nutr ESPEN. 2018 Apr;24:148-155. doi: 10.1016/j.clnesp.2017.11.010. Epub 2018 Jan 3.
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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 Percival, PhD principal investigator
University of Florida
2 sites 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 Supplementation Group and Standard for Groups in people with Healthy, run by University of Florida at 2 sites 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 4 inclusion and 6 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 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Markers of immune health (time frame: 6 weeks). 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 NCT01959646, which also lists 1 linked publication.
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 26 Feb 2016.