The Effect of AGE on the Immune System
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 25 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | January 2014 |
| End Date: | November 2015 |
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).
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).
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.
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.
Inclusion Criteria:
- ages 25-65
- BMI > or = to 30 kg/m2
- willing to discontinue dietary supplements
- cRP between 2 and 10 mg/L
Exclusion Criteria:
- 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
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