The Effect of AGE on the Immune System (EAGESIS II)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01959646
First received: October 8, 2013
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention
Healthy
Dietary Supplement: Aged Garlic Extract Supplementation Group
Other: Standard for Groups
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Aged Garlic Extract Supplementation on the Immune System

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Markers of immune health [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Number and function of gamma delta T-cells and monocytes


Secondary Outcome Measures:
  • Markers of inflammation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    IL-6 and TNF alpha


Other Outcome Measures:
  • Serum antioxidant status (compliance) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Serum glutathione


Estimated Enrollment: 80
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo Group
Other: Standard for Groups
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.
Dietary Supplement: Placebo
Participants will be asked to consume three (3) placebo capsules with food twice a day.
Experimental: Aged Garlic Extract Supplementation
Aged Garlic Extract Supplementation Group
Dietary Supplement: Aged Garlic Extract Supplementation Group
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.
Other Name: AGE
Other: Standard for Groups
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.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01959646

Contacts
Contact: Susan Percival, PhD 352-392-1991 ext 202 percival@ufl.edu
Contact: Anne Mathews, PhD, RD 352-392-1991 ext 286 anne.mathews@ufl.edu

Locations
United States, Florida
Food Science & Human Nutrition Building, University of Florida Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Susan Percival, PhD    352-392-1991 ext 202    percival@ufl.edu   
Contact: Anne Mathews, PhD, RD    352-392-1991 ext 286    anne.mathews@ufl.edu   
Principal Investigator: Susam S Percival, PhD         
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Susan Percival, Ph.D    352-392-1991 ext 202    percival@ufl.edu   
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Susan Percival, PhD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01959646     History of Changes
Other Study ID Numbers: IRB201300529
Study First Received: October 8, 2013
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Immune Function
Aged Garlic Extract
Supplementation
Inflammation

ClinicalTrials.gov processed this record on September 22, 2014