Trial of Supplementation With Aged Garlic Extract to Improve Endothelial Function in Patients With Metabolic Syndrome (Kymes)
Recruitment status was Recruiting
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Purpose
Many studies have addressed the relationship between metabolic syndrome and cardiovascular disease. Risk factors include abdominal obesity, insulin resistance, abnormal lipid profile and hypertension. It is proposed that this condition leads to an increase in the production of inflammatory substances and endothelial dysfunction.
New therapies have been studied to improve control of metabolic disorders and reduce the endothelium damage. Aged garlic extract (Kyolic®) is a promising intervention that has antithrombotic and antioxidant properties. At the moment there is not data about the effects of supplementation with AGE in the endothelial function of patients with metabolic syndrome. Thus, the purpose of this study is to investigate if the supplementation with Kyolic® can alter the plasma levels of inflammatory markers, insulin and the endothelial function of patients with metabolic syndrome.
Methods and design: A randomized, cross over, double-blind, placebo-controlled trial will be performed to assess the effects of 1.2 g of Kyolic in insulin resistance and endothelial function of 46 patients with diagnosis of metabolic syndrome. The participants will be recruited from the primary care centers from E.S.E ISABU Bucaramanga. All subjects who meet the inclusion criteria will be randomly assigned to two periods of 12 weeks (Kyolic and placebo). Control visits will be programmed monthly to verify compliance and the presence of adverse events. Outcome variables (endothelial function assessed by flow mediated vasodilation, inflammatory markers, insulin plasma levels) will be evaluated at the initial visit and after 12 and 24 weeks of treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Metabolic Syndrome |
Drug: aged garlic extract Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF THE SUPPLEMENTATION WITH KIOLIC® IN PATIENTS WITH DIAGNOSIS OF METABOLIC SYNDROME TO IMPROVE ENDOTHELIAL FUNCTION AND INFLAMMATORY STATE. "KYMES" |
- Endothelial function assessed by flow mediated vasodilation and plasma levels of nitrites/nitrates [ Time Frame: 12, 24 weeks ] [ Designated as safety issue: No ]
The flow mediated vasodilation is a non-invasive diagnostic test using high-resolution doppler ultrasound, that measures the changes in diameter of the brachial artery in response to increased blood flow (reactive hyperemia).
The plasma levels of nitrites/nitrates will be determined by immunoassay (R&D Systems, Inc)
- Plasma concentrations of C-reactive protein and interleukin-6 [ Time Frame: 12, 24 weeks ] [ Designated as safety issue: No ]During the initial and follow-up visits, a blood sample will be taken to determine C-reactive protein by high sensitivity chemiluminescent immunometric assay (IMMULITE 1000, DPC, Los Angeles, CA) and Interleukin-6 by immunoassay (Biosource International, Camarillo, CA)
- Plasma insulin and glucose levels [ Time Frame: 12, 24 weeks ] [ Designated as safety issue: No ]Blood samples will be taken at the initial and follow-up visits (12,24 weeks) to determine blood glucose by automatic colorimetric method (Baker System 9120 AX, Biochem Immunosystem, Allentown, PA)and insulin plasma levels by high sensitivity chemiluminescent immunometric assay (IMMULITE 1000, DPC, Los Angeles, CA).
- Waist and hip circumference [ Time Frame: 12, 24 weeks ] [ Designated as safety issue: No ]Anthropometric measures will be determined at the initial and follow-up visits (12,24 weeks).
- Plasma levels of Adiponectin [ Time Frame: initial visit, 12, 24 weeks ] [ Designated as safety issue: No ]Blood samples will be taken at the initial and follow-up visits (12,24 weeks) to determine adiponectin by Human Adiponectin/Acrp30 Quantikine ELISA (R&D Systems, USA)
| Estimated Enrollment: | 46 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo 1.2 g per day for 12 weeks, followed by a second treatment period with aged garlic extract during 12 more weeks.
|
Drug: Placebo
Placebo 1.2 g per day for 12 weeks.
|
|
Experimental: Aged garlic extract (Kyolic ®)
Aged garlic extract, 1.2 g per day for 12 weeks, followed by a second treatment period with placebo during 12 more weeks.
|
Drug: aged garlic extract
Aged garlic extract, 1.2 g per day for 12 weeks
Other Name: Kyolic
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women over 18 years old with metabolic syndrome diagnosed by the presence of central obesity (waist circumference ≥ 90cm (male), ≥ 80 cm (female)) and two of the following criteria:
- Triglycerides ≥ 150 mg/dl
- High density lipoprotein cholesterol <40 mg/dL (male),<50 mg/dL (female)
- Blood pressure ≥ 130/85 mmHg
- Fasting plasma glucose ≥ 100 mg/dl
Exclusion Criteria:
- Garlic allergy
- Patients with psychiatric disorders that prevent proper decision-making
- Patients with infections or inflammatory conditions
- Presence of coronary artery disease
- Presence of severe chronic or terminal illnesses.
- Presence of diseases that compromise the immune system.
Contacts and Locations| Contact: Patricio Lopez-Jaramillo, MD, PhD | 577-6382828 ext 2510 | jplopezj@hotmail.com |
| Contact: Ronald G Garcia, MD, PhD | 577-6399292 ext 344 | carontevs@gmail.com |
| Colombia | |
| Medicine School, Universidad de Santander | Recruiting |
| Bucaramanga, Santander, Colombia, 0000000 | |
| Sub-Investigator: Yudy A Rodriguez, Bact | |
| Sub-Investigator: Ronald G García, MD, PhD | |
| Principal Investigator: | Patricio López-Jaramillo, MD, PhD | Universidad de Santander |
More Information
Publications:
| Responsible Party: | Patricio López-Jaramillo, Universidad de Santander |
| ClinicalTrials.gov Identifier: | NCT01168700 History of Changes |
| Other Study ID Numbers: | Kymes-Wakunaga-UDES |
| Study First Received: | July 21, 2010 |
| Last Updated: | July 21, 2010 |
| Health Authority: | Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) |
Keywords provided by Universidad de Santander:
|
Metabolic syndrome, Aged Garlic Extract, Insulin, inflammation, endothelium. |
Additional relevant MeSH terms:
|
Metabolic Syndrome X Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013