The Effect of AGE on the Immune System

NCT ID: NCT01959646

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-11-30

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo Group

Group Type: PLACEBO_COMPARATOR

Standard for Groups

Intervention Type: OTHER

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.

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Participants will be asked to consume three (3) placebo capsules with food twice a day.

Aged Garlic Extract Supplementation

Aged Garlic Extract Supplementation Group

Group Type: EXPERIMENTAL

Aged Garlic Extract Supplementation Group

Intervention Type: DIETARY_SUPPLEMENT

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 Groups

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Placebo

Participants will be asked to consume three (3) placebo capsules with food twice a day.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

AGE

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Percival, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Food Science & Human Nutrition Building, University of Florida

Gainesville, Florida, United States

University of Florida

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29576354 (View on PubMed)

Other Identifiers

IRB201300529

Identifier Type: -

Identifier Source: org_study_id