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

• ClinicalTrials.gov Identifier: NCT01959646
• Recruitment Status: Completed
• First Posted: October 10, 2013
• Last Update Posted: February 26, 2016
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Healthy	Dietary Supplement: Aged Garlic Extract Supplementation Group; Other: Standard for Groups; Dietary Supplement: Placebo	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Aged Garlic Extract Supplementation on the Immune System
• Study Start Date: January 2014
• Actual Primary Completion Date: November 2015
• Actual Study Completion Date: November 2015

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Markers of immune health [ Time Frame: 6 weeks ]
   Number and function of gamma delta T-cells and monocytes

Secondary Outcome Measures :

1. Markers of inflammation [ Time Frame: 6 weeks ]
   IL-6 and TNF alpha

Other Outcome Measures:

1. Serum antioxidant status (compliance) [ Time Frame: 6 weeks ]
   Serum glutathione

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Florida

Food Science & Human Nutrition Building, University of Florida

Gainesville, Florida, United States, 32611

University of Florida

Gainesville, Florida, United States, 32611

Sponsors and Collaborators

University of Florida

Investigators

• Principal Investigator: Susan Percival, PhD; University of Florida

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT01959646
• Other Study ID Numbers: IRB201300529
• First Posted: October 10, 2013
• Last Update Posted: February 26, 2016
• Last Verified: February 2016

Keywords provided by University of Florida:

Immune Function; Aged Garlic Extract; Supplementation; Inflammation