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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03931434

Recruitment Status Completed

First Posted April 30, 2019

Last update posted April 30, 2019

Study Description

Brief summary:

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.

  • Condition or Disease:Type 2 Diabetes Mellitus
    Coronary Arteriosclerosis
    Endothelial Dysfunction
  • Intervention/Treatment: Dietary Supplement: Aged Garlic Extract (AGE)
    Dietary Supplement: Placebo
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Actual Enrollment: 88 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Double Blind Placebo Controlled
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Effect of Aged Garlic Extract (AGE) on Progression of Coronary Atherosclerosis in Persons With Type 2 Diabetes Mellitus
  • Actual Study Start Date: February 2016
  • Actual Primary Completion Date: May 2018
  • Actual Study Completion Date: May 2018
Arms and interventions
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
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. Rate of change in inflammatory biomarkers (CRP,IL-6) [ Time Frame: 12 months ]
    Rate of change in inflammatory biomarkers
  • 2. 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)
Eligibility Criteria
  • Ages Eligible for Study: 30 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

More Information
  • Responsible Party: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • ClinicalTrials.gov Identifier: NCT03931434 History of Changes
  • Other Study ID Numbers: Garlic-5
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: April 30, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: Endothelium coronary artery disease
  • Additional relevant MeSH terms: Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Atherosclerosis
    Arteriosclerosis
    Coronary Artery Disease
    Myocardial Ischemia