The Effect of AGE on the Immune System
Condition: Healthy
Study type: Interventional

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. 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.
    

Intervention name(s): Aged Garlic Extract Supplementation Group; Standard for Groups; Placebo
Intervention type(s): Dietary Supplement; Other; Dietary Supplement
Intervention description(s): 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.; 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.; Participants will be asked to consume three (3) placebo capsules with food twice a day.
Other intervention name(s): AGE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Immune Function; Aged Garlic Extract; Supplementation; Inflammation