Aged Garlic Extract Study

NCT03860350 | Completed DMC

• 1 other identifier: DNR2016/745
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Microcirculation; Biomarkers

Keywords

garlic

Outcome Measures

Primary Outcomes (1)

• Change in coronary artery calcium (CAC) score

  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.

  One year

Secondary Outcomes (12)

• The changes in inflammatory biomarkers.

  One Year

• The changes in Interleukin-6 (IL-6)

  One Year

• The changes in inflammatory biomarkers.

  One Year

• The changes in the microcirculation measured by Laser Doppler velocimetry

  One Year

• Changes in Low Density Lipoprotein

  One Year

Study Arms (2)

Aged Garlic Extract

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Aged Garlic Extract DIETARY_SUPPLEMENT

Also known as: Kyolic

Aged Garlic Extract

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (1)

Skane University Hospital

Lund, 22241, Sweden

Location

Related Publications (8)

• Agatston AS, Janowitz WR, Hildner FJ, Zusmer NR, Viamonte M Jr, Detrano R. Quantification of coronary artery calcium using ultrafast computed tomography. J Am Coll Cardiol. 1990 Mar 15;15(4):827-32. doi: 10.1016/0735-1097(90)90282-t.

  PMID: 2407762 BACKGROUND

• Lindstedt S, Malmsjo M, Hansson J, Hlebowicz J, Ingemansson R. Microvascular blood flow changes in the small intestinal wall during conventional negative pressure wound therapy and negative pressure wound therapy using a protective disc over the intestines in laparostomy. Ann Surg. 2012 Jan;255(1):171-5. doi: 10.1097/SLA.0b013e31823c9ffa.

  PMID: 22104565 BACKGROUND

• Lindstedt S, Malmsjo M, Hlebowicz J, Ingemansson R. Comparative study of the microvascular blood flow in the intestinal wall, wound contraction and fluid evacuation during negative pressure wound therapy in laparostomy using the V.A.C. abdominal dressing and the ABThera open abdomen negative pressure therapy system. Int Wound J. 2015 Feb;12(1):83-8. doi: 10.1111/iwj.12056. Epub 2013 Mar 21.

  PMID: 23517436 BACKGROUND

• Lindstedt S, Malmsjo M, Ingemansson R. No hypoperfusion is produced in the epicardium during application of myocardial topical negative pressure in a porcine model. J Cardiothorac Surg. 2007 Dec 6;2:53. doi: 10.1186/1749-8090-2-53.

  PMID: 18062803 BACKGROUND

• Lindstedt S, Malmsjo M, Ingemansson R. Blood flow changes in normal and ischemic myocardium during topically applied negative pressure. Ann Thorac Surg. 2007 Aug;84(2):568-73. doi: 10.1016/j.athoracsur.2007.02.066.

  PMID: 17643636 BACKGROUND

• Budoff MJ, Ahmadi N, Gul KM, Liu ST, Flores FR, Tiano J, Takasu J, Miller E, Tsimikas S. Aged garlic extract supplemented with B vitamins, folic acid and L-arginine retards the progression of subclinical atherosclerosis: a randomized clinical trial. Prev Med. 2009 Aug-Sep;49(2-3):101-7. doi: 10.1016/j.ypmed.2009.06.018. Epub 2009 Jun 30.

  PMID: 19573556 BACKGROUND

• Wlosinska M, Nilsson AC, Hlebowicz J, Fakhro M, Malmsjo M, Lindstedt S. Aged Garlic Extract Reduces IL-6: A Double-Blind Placebo-Controlled Trial in Females with a Low Risk of Cardiovascular Disease. Evid Based Complement Alternat Med. 2021 Mar 31;2021:6636875. doi: 10.1155/2021/6636875. eCollection 2021.

  PMID: 33868439 DERIVED

• Wlosinska M, Nilsson AC, Hlebowicz J, Hauggaard A, Kjellin M, Fakhro M, Lindstedt S. The effect of aged garlic extract on the atherosclerotic process - a randomized double-blind placebo-controlled trial. BMC Complement Med Ther. 2020 Apr 29;20(1):132. doi: 10.1186/s12906-020-02932-5.

  PMID: 32349742 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

kyolic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Sandra Lindstedt, MD, PhD

  Skane University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant and Associate Professor

Model Details: Double blind placebo controlled prospective study

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 1, 2019
• Study Start: December 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 11, 2019

Record last verified: 2019-06

Locations

SE (1)