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The BANGALORE Study; Combination of Berberine, Lipoic Acid, and Picrorhiza

NCT01696448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2014-11-13

No results posted yet for this study

Summary

Though medical treatment has been effective in the treatment of cardiometabolic diseases (including coronary atherosclerosis and diabetes mellitus), the incidence of these disorders continues to be high. Many reasons are responsible, but lifestyle changes, including an increased prevalence of obesity and the metabolic syndrome, are significant for this cause. Diagnosis and treatment of obese patients with hypertension requires that health care providers address the issues of hypertension, glucose intolerance, body weight and dyslipidemia. A sedentary lifestyle and poor cardiorespiratory fitness are not only associated with the (cardio) metabolic syndrome but could actually be considered features of the metabolic syndrome. These issues are significant in the health of certain individuals, who experience greater difficulty in treated BP control, experience increased hypertensive and diabetic complications, and have higher levels of obesity.

In this study, the investigators will evaluate the efficacy of the nutritional supplements berberine, alpha-lipoic acid, and picrorhiza (CAR-191) when consumed 30 minutes before meals, on appetite suppression, body composition and weight control. Additionally, the investigators will evaluate the effects of this combination of nutraceuticals on the mechanistic effects of oxidation, inflammation, and vascular function in a high-risk population with the metabolic syndrome.

Primary Objective To assess the comparative effect of a combination (known as CAR-191) of berberine (200 mg), alpha-lipoic acid (150 mg), and picrorhiza (100 mg) three times a day, compared to placebo three times a day, on parameters relate to appetite suppression, weight control and body composition in a high risk population with the metabolic syndrome.

Secondary Co-objectives

To evaluate the effects of CAR-191 versus placebo on changes in:

* Endothelial function using noninvasive brachial artery reactivity (BAR) ultrasound
* Biomarkers including IL-6, HOMA-IR, HbA1C, hsCRP, adiponectin, plasma/urine isoprostanes, PAI-1, TNFα-II, aldosterone, and glutathione redox ratio
* Urinary protein excretion
* Clinical chemistry including plasma glucose, blood urea nitrogen, creatinine, total bilirubin, uric acid, transaminases (SGOT/AST, SGPT/ALT), alkaline phosphatase, C-reactive protein, and lipoproteins

Conditions

  • Metabolic Syndrome

Interventions

DIETARY_SUPPLEMENT

CAR-191

Patients will be randomized to the CAR-191 intervention group in a 3:1, CAR0-191:placebo ratio. There will be 30 patients in the CAR-191 treatment group.

OTHER

Placebo

Patients will be randomised in a 3:1 ratio. There will be 10 patients in the placebo group.

Sponsors & Collaborators

  • Atlanta Vascular Research Foundation

    collaborator OTHER

  • Carmel Biosciences

    lead INDUSTRY

Principal Investigators

  • Syed T Rahman, MD · Atlanta Vascular Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01696448 on ClinicalTrials.gov