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The Effect of AGE on the Immune System

NCT01959646 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2016-02-26

No results posted yet for this study

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).

Conditions

  • Healthy

Interventions

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

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.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Susan Percival, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01959646 on ClinicalTrials.gov