Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
The BANGALORE Study; Combination of Berberine, Lipoic Acid, and Picrorhiza
NCT01696448 · View on ClinicalTrials.gov ↗
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
Conditions Studied
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT CAR-191
Study Locations (1)
Georgia
- Atlanta Vascular Research Foundation — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-04 |
| Phase | NA |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01696448
The ClinicalTrials.gov registry entry for NCT01696448 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carmel Biosciences, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Metabolic Syndrome appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01696448 reports 1 study location spanning 1 distinct geographic area — top geographies include Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01696448 about?
NCT01696448 is a clinical study titled "The BANGALORE Study; Combination of Berberine, Lipoic Acid, and Picrorhiza". 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 obesit...
What is the current status of trial NCT01696448?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2012-08. Estimated completion is 2013-04.
What conditions does trial NCT01696448 study?
This clinical trial studies the following conditions: Metabolic Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01696448?
The interventions under investigation include: Placebo (OTHER), CAR-191 (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01696448?
This trial is sponsored by Carmel Biosciences, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01696448 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.