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

NCT01168700 | Unknown Phase 4

• 1 other identifier: Kymes-Wakunaga-UDES
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome

Keywords

Metabolic syndrome, Aged Garlic Extract, Insulin, inflammation, endothelium.

Outcome Measures

Primary Outcomes (1)

• Endothelial function assessed by flow mediated vasodilation and plasma levels of nitrites/nitrates

  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)

  12, 24 weeks

Secondary Outcomes (4)

• Plasma concentrations of C-reactive protein and interleukin-6

  12, 24 weeks

• Plasma insulin and glucose levels

  12, 24 weeks

• Waist and hip circumference

  12, 24 weeks

• Plasma levels of Adiponectin

  initial visit, 12, 24 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Aged garlic extract (Kyolic ®)

EXPERIMENTAL

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

Interventions

aged garlic extract DRUG

Aged garlic extract, 1.2 g per day for 12 weeks

Also known as: Kyolic

Aged garlic extract (Kyolic ®)

Placebo DRUG

Placebo 1.2 g per day for 12 weeks.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Santander: lead
• Instituto de Salud de Bucaramanga: collaborator

Study Sites (1)

Medicine School, Universidad de Santander

Bucaramanga, Santander Department, 0000000, Colombia

RECRUITING

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MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance; Inflammation

Interventions

kyolic

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricio López-Jaramillo, MD, PhD

  Universidad de Santander

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricio Lopez-Jaramillo, MD, PhD

CONTACT

577-6382828; jplopezj@hotmail.com

Ronald G Garcia, MD, PhD

CONTACT

577-6399292; carontevs@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 23, 2010
• Study Start: November 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 23, 2010

Record last verified: 2010-07

Locations

CO (1)