Effect of Aged Garlic Extract (AGE) on Improving Coronary Atherosclerosis in People With Type 2 Diabetes Mellitus

April 29, 2019 updated by: Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Effect of Aged Garlic Extract (AGE) on Progression of Coronary Atherosclerosis in Persons With Type 2 Diabetes Mellitus

The purpose of this research study is to see the effect of taking Aged Garlic Extract (AGE) on the progression of coronary plaque, a condition called atherosclerosis, in people diagnosed with Diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This clinical trial is to determine on progression rates of low attenuation plaque under influence of Aged Garlic Extract as compared to placebo over the 1year period in individuals with Type 2 Diabetes Mellitus.The study also examines the effect of Aged Garlic Extract on endothelial function and arterial stiffness which was measured by cardio-ankle vascular index (CAVI) over the 3months period.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90502
        • Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 30-75 years
  • Known Diabetes Mellitus (HgA1c >6.5%, fasting blood sugar >125 mg/dl, taking anti- diabetes medications)
  • Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them
  • Calcium Score >20 at baseline

Exclusion Criteria:

  • A contraindication to AGE including: known hypersensitivity to drug.
  • Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
  • Weight in excess of 350 pounds
  • Bleeding disorder
  • History of known coronary artery disease, myocardial infarction, stroke or life- threatening arrhythmia within the prior six months
  • NYHA Class II- IV heart failure
  • History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
  • Serum creatinine > 1.4 mg/dl
  • Triglycerides > 400 at visit 1
  • Drug or alcohol abuse, or current intake of more than 14 standard drinks per week
  • Concurrent enrollment in another placebo-controlled trial
  • Partial ileal bypass or known gastrointestinal disease limiting drug absorption
  • Current tobacco use
  • Current use of anticoagulants (except for anti-platelet agents)
  • Renal failure
  • History of hypertensive encephalopathy or cerebrovascular accident
  • Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Aged Garlic Extract (AGE)
2400mg of Aged Garlic Extract (AGE)
Dietary supplement: Aged Garlic Extract (AGE)
2400mg of Aged Garlic Extract (AGE)
PLACEBO_COMPARATOR: Placebo
The Placebo does not contain any Aged Garlic Extract (AGE)
Dietary supplement: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo.
Time Frame: 12 months
Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of change in inflammatory biomarkers (CRP,IL-6)
Time Frame: 12 months
Rate of change in inflammatory biomarkers
12 months
Rate of change in endothelial function
Time Frame: 3 months and 12 months
Endothelial Function and arterial stiffness measured by cardio-ankle vascular index (CAVI)
3 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 23, 2016

Primary Completion (ACTUAL)

May 7, 2018

Study Completion (ACTUAL)

May 7, 2018

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

April 29, 2019

First Posted (ACTUAL)

April 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Garlic-5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe