Trial of Supplementation With Aged Garlic Extract to Improve Endothelial Function in Patients With Metabolic Syndrome

• Status: Unknown status
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad de Santander
• Collaborator: Instituto de Salud de Bucaramanga

Criteria

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.