Coronary Artery DiseaseAGENCT03860350
Aged Garlic Extract Study
A study testing Aged Garlic Extract in people with Coronary Artery Disease and Microcirculation, run by Lund University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Microcirculation, Biomarkers
- What is being tested?
- Aged Garlic Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2016to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aged Garlic Extract (Kyolic) Study at Lund University, Sweden
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Microcirculation, Biomarkers
- Being tested
- Aged Garlic Extract, Placebo
- Keywords
- garlic
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aged Garlic ExtractDietary supplement
Also called Kyolic
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (12)
The changes in inflammatory biomarkers.
Changes in C-reactive protein (CRP mg/L)
Measured: One Year
The changes in Interleukin-6 (IL-6)
Changes in IL-6 (ng/L)
Measured: One Year
The changes in inflammatory biomarkers.
Changes in Homocystein (µmol/L)
Measured: One Year
The changes in the microcirculation measured by Laser Doppler velocimetry
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.
Measured: One Year
Changes in Low Density Lipoprotein
Changes of Low Density Lipoprotein (LDL) mmol/L
Measured: One Year
Changes in Triglycerides
Changes of Triglycerides mmol/L.
Measured: One Year
Changes in Cholesterol
Changes of cholesterol mmol/L.
Measured: One Year
Changes in High Density Lipoprotein
Changes of High Density Lipoprotein(HDL) mmol/L,
Measured: One Year
Changes in lipid profile
Apolipoprotein B (mmol/L)/Apolipoprotein A1 (mmol/L)
Measured: One Year
Changes in blood sugar
Changes in fastening blood glucose measured as mmol/L
Measured: One Year
Changes in Blood pressure
Changes of blood pressure Systolic and Diastolic presented as mmHg.
Measured: One Year
Changes in BMI
Changes in BMI measured as weight (kg) and height (m) and will be combined to report BMI in kg/m^2
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Dec 2016
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind placebo controlled prospective study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Lindstedt Ingemansson, Lund University Hospital
- Investigators
- Sandra Lindstedt, MD, PhD, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860350
- Sponsor's protocol ID
- DNR2016/745
- Acronym
- AGE
- Status last verified
- Jun 2019
- First submitted
- 26 Feb 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 2407762Lindstedt 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.
PubMed 22104565Lindstedt 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.
PubMed 23517436Lindstedt 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.
PubMed 18062803Lindstedt 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.
PubMed 17643636Budoff 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.
PubMed 19573556Wlosinska 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.
PubMed 33868439Wlosinska 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.
PubMed 32349742
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aged Garlic Extract (Kyolic) Study at Lund University, Sweden
- ClinicalTrials.gov ID
- NCT03860350
- Acronym / sponsor ID
- AGE / DNR2016/745
- Conditions
- Coronary Artery Disease, Microcirculation, Biomarkers
- Keywords
- garlic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind placebo controlled prospective study
| Arm | Type | Receives |
|---|---|---|
| Aged Garlic Extract | Active comparator | Dietary Supplement: Aged Garlic ExtractThe 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aged Garlic ExtractAlso: Kyolic | Dietary supplement | Aged Garlic Extract |
| Placebo | Dietary supplement | Placebo |
Primary outcome
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.
12 secondary outcomes
The changes in inflammatory biomarkers.
Time frame: One Year
The changes in Interleukin-6 (IL-6)
Time frame: One Year
The changes in inflammatory biomarkers.
Time frame: One Year
The changes in the microcirculation measured by Laser Doppler velocimetry
Time frame: One Year
Changes in Low Density Lipoprotein
Time frame: One Year
Changes in Triglycerides
Time frame: One Year
Changes in Cholesterol
Time frame: One Year
Changes in High Density Lipoprotein
Time frame: One Year
Changes in lipid profile
Time frame: One Year
Changes in blood sugar
Time frame: One Year
Changes in Blood pressure
Time frame: One Year
Changes in BMI
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Background: PubMed 2407762Agatston 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.
- Background: PubMed 22104565Lindstedt 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.
- Background: PubMed 23517436Lindstedt 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.
- Background: PubMed 18062803Lindstedt 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.
- Background: PubMed 17643636Lindstedt 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.
- Background: PubMed 19573556Budoff 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.
- Derived from this study: PubMed 33868439Wlosinska 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.
- Derived from this study: PubMed 32349742Wlosinska 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Lindstedt, MD, PhD principal investigator
Skane University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aged Garlic Extract in people with Coronary Artery Disease and Microcirculation, run by Lund University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in coronary artery calcium (CAC) score (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03860350, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.