Trial of Supplementation With Aged Garlic Extract to Improve Endothelial Function in Patients With Metabolic Syndrome (Kymes)
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
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 ]
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 ]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 ]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 ]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 ]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)
|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)|
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.
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01168700
|Medicine School, Universidad de Santander|
|Bucaramanga, Santander, Colombia, 0000000|
|Principal Investigator:||Patricio López-Jaramillo, MD, PhD||Universidad de Santander|