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NCT01696448 · ClinicalTrials.gov registry record · NA
The BANGALORE Study; Combination of Berberine, Lipoic Acid, and Picrorhiza
A NA study of Metabolic Syndrome, sponsored by Carmel Biosciences.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT01696448: Completed NA study of Metabolic Syndrome, sponsored by Carmel Biosciences.
NCT01696448 is a NA study of Metabolic Syndrome that has completed, run by Carmel Biosciences. The registered enrollment target is 28 participants, below the 1,205-participant average among 102 other Metabolic Syndrome trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01696448, a NA study of Metabolic Syndrome, has completed, sponsored by Carmel Biosciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
Change in appetite will be measured through food frequency and appetite questionnaires
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 |
What the finished NCT01696448 record still lists
NCT01696448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,205-participant average among 102 other Metabolic Syndrome trials with a reported enrollment target (98% lower).
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.
NCT01696448 reports a single indexed study location in Georgia.
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.
What interventions are being tested in trial NCT01696448?
The interventions under investigation include: Placebo (OTHER), CAR-191 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01696448?
This trial is sponsored by Carmel Biosciences, which has 1 total clinical trials registered on ClinicalTrials.gov.
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
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Where NCT01696448's enrollment target sits among peer trials
28 80th of 102 higher than 22 of 102 other Metabolic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metabolic Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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