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Aged Garlic Extract Study (AGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03860350
Recruitment Status : Active, not recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Sandra Lindstedt Ingemansson, Lund University Hospital

Brief Summary:
The primary intention of the study is to examine the effect of aged garlic extract (AGE) on the absolute change in coronary artery calcium (CAC). The second intention is to examine the effect of AGE on inflammatory biomarkers and microcirculation. It is a double blind placebo controlled study. The participants will ingest AGE during a period of one year. The CAC will be controlled by computer tomography (CT) scan; the inflammatory biomarkers through blood sample test and the microcirculation through laser speckel imagining and laser doppler before and after the one year period of AGE ingestion.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Microcirculation Biomarkers Dietary Supplement: Aged Garlic Extract Dietary Supplement: Placebo Not Applicable

Detailed Description:

Objectives:

Effect on coronary artery atherosclerosis / the progression of atherosclerosis Effect on inflammatory and oxidation biomarkers Cholesterol lowering effect Effect on microcirculation

Type of study:

Randomized double blind controlled trial

Number of patients: 80 patients

Duration of the study:

The patients will be studied for one year after they have entered the study. The total time of the study duration from the including date of the first patient to the analysis of the last patient entering the study estimated to be 2-3 years. An inclusion rate off 1 to 2 patients per week.

Treatment:

Dose: Treated with a placebo capsule or a capsule containing a total of AGE 2400 mg daily for 1 year (2 Kyolic capsule (600 mg) twice daily).

Methods:

Placebo-controlled double blind randomized trial to determine whether AGE can influence the rate of atherosclerosis plaque burden measured by coronary artery calcium, improve vascular function and microcirculation and favorably change biomarkers of oxidative stress.

Randomization:

The participants are assigned to AGE or placebo in a double-blinded manner, using numbered containers assigned to a computer-generated randomization chart by a nurse coordinator.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind placebo controlled prospective study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Aged Garlic Extract (Kyolic) Study at Lund University, Sweden
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Aged Garlic Extract
The participants will ingest 600 mg of Aged Garlic Extract in two capsules two times a day i.e. 1200 mg/day during a period of one year.
Dietary Supplement: Aged Garlic Extract
Other Name: Kyolic

Placebo Comparator: Placebo
The participants will ingest 600 mg of placebo in two capsules two times a day i.e. 1200 mg/day during a period of one year.
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Change in coronary artery calcium (CAC) score [ Time Frame: One year ]
    CAC is to be defined as a plaque of at least three contiguous pixels (area 1.02 mm 2) with a density of > 130 Hounsfield units. The lesion score are to be calculated by multiplying the lesion area by a density factor derived from the maximal Hounsfield unit within this area, as described by Agatston S, Janowitz WR, Hildner FJ et al. Quantification of coronary artery calcium using ultrafast computed tomography. J Am Coll Cardiol 1990; 15: 827-832. CAC score is measured at baseline and after one year follow-up and the difference is calculated.


Secondary Outcome Measures :
  1. The changes in inflammatory biomarkers. [ Time Frame: One Year ]
    Changes in C-reactive protein (CRP mg/L)

  2. The changes in Interleukin-6 (IL-6) [ Time Frame: One Year ]
    Changes in IL-6 (ng/L)

  3. The changes in inflammatory biomarkers. [ Time Frame: One Year ]
    Changes in Homocystein (µmol/L)

  4. The changes in the microcirculation measured by Laser Doppler velocimetry [ Time Frame: One Year ]
    Laser Doppler Flowmetry (LDF) is a non-invasive method to estimate the blood perfusion in the microcirculation. The advantage of the technique is that LDF provide a continuous or near continuous record of the microvascular blood flow. No current laser Doppler instrument can present absolute perfusion values (e.g. ml/min/100 gram tissue). Measurements are expressed as perfusion units (PU) which are arbitrary. The changes in PU will be measured.

  5. Changes in Low Density Lipoprotein [ Time Frame: One Year ]
    Changes of Low Density Lipoprotein (LDL) mmol/L

  6. Changes in Triglycerides [ Time Frame: One Year ]
    Changes of Triglycerides mmol/L.

  7. Changes in Cholesterol [ Time Frame: One Year ]
    Changes of cholesterol mmol/L.

  8. Changes in High Density Lipoprotein [ Time Frame: One Year ]
    Changes of High Density Lipoprotein(HDL) mmol/L,

  9. Changes in lipid profile [ Time Frame: One Year ]
    Apolipoprotein B (mmol/L)/Apolipoprotein A1 (mmol/L)

  10. Changes in blood sugar [ Time Frame: One Year ]
    Changes in fastening blood glucose measured as mmol/L

  11. Changes in Blood pressure [ Time Frame: One Year ]
    Changes of blood pressure Systolic and Diastolic presented as mmHg.

  12. Changes in BMI [ Time Frame: One Year ]
    Changes in BMI measured as weight (kg) and height (m) and will be combined to report BMI in kg/m^2



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CAC score >10
  • Framingham risk score (10 % or above)
  • Subjects are required to be on stable concomitant medications for at least 12 weeks prior to randomization
  • Subjects with diabetic must have HbA1C < 8.0, and stable HbA1C level variation range within 0.5% for three months.

Exclusion Criteria:

  • Hypersensitivity to AGE therapy,
  • Unstable medical, psychiatric, or substance abuse disorder that may interfere with continuation in the study,
  • Weight ≥325 pounds,
  • Bleeding disorder,
  • History of myocardial infarction,
  • Stroke
  • Life-threatening arrhythmia within prior 6 months,
  • Resting hypotension (systolic < 90 mmHg) or hypertension (resting blood pressure >170/110)
  • Heart failure NYHA class III or IV,
  • 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 baseline visit
  • Diabetic subjects with HbA1C > 8 %,
  • Drug or alcohol abuse
  • Conditions interfering with accurate assessment of coronary calcification (metal clips, bypass patients, intracoronary stents) and drug absorption (partial ileal bypass or malabsorption syndrome).
  • Current use of anticoagulants (except for antiplatelet agents)
  • Chronic renal failure
  • Liver failure
  • Hematological or biochemical values at baseline visit outside the reference ranges considered as clinically significant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860350


Locations
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Sweden
Skane University Hospital
Lund, Sweden, 22241
Sponsors and Collaborators
Lund University Hospital
Investigators
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Principal Investigator: Sandra Lindstedt, MD, PhD Skane University Hospital

Publications:

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Responsible Party: Sandra Lindstedt Ingemansson, Senior Consultant and Associate Professor, Lund University Hospital
ClinicalTrials.gov Identifier: NCT03860350     History of Changes
Other Study ID Numbers: DNR2016/745
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Sandra Lindstedt Ingemansson, Lund University Hospital:
garlic

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases