CompletedNot Applicable

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

United States28 participantsStarted 2012-08

Plain-language 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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and female subjects ≥ 18 years and ≤ 80 years with (cardio)metabolic syndrome as identified by investigators, OR * Male and female subjects ≥ 18 years and ≤ 80 years with (cardio)metabolic syndrome defined by ATP-III criteria: Insulin resistance, identified by 1 of the following * Type 2 diabetes with HgA1C \< 8.0% or on medical therapy * Impaired fasting glucose * Impaired glucose tolerance * Or for those with normal fasting glucose levels (\<100 mg/dl), glucose uptake below the lowest quartile for background population under investigation under hyperinsulinemic, euglycemic conditions Plus any 2 of the following: * Plasma triglycerides ≥ 150 mg/dl (≥ 1.7 mmol/L) * HDL cholesterol \<35 mg/dl (\<0.9 mmol/L) in men or \<39 mg/dl) (1.0 mmol/L) in women * BMI \>30 kg/m2 and/or waist:hip ratio \> 0.9 in men, \>0.85 in women * Urinary albumin excretion rate ≥ 20 µg/min or albumin:creatinine ratio ≥ 30 mg/g Exclusion Criteria: * • Females of childbearing potential who are pregnant, lactating or who do not employ adequate birth control procedures. * Presence of any serious disorder including, renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic (with the exception of non-insulin dependent type 2 diabetes), hematologic/oncologic, neurologic and psychiatric diseases are exclusionary. * History of heart failure. * Stroke or heart attack within past 6 months. * Use of insulin. * Non-dominant upper arm circumference greater than 50 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

appetite suppression

Timeframe: 12 weeks

Trial details

NCT IDNCT01696448

SponsorCarmel Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-04

View on ClinicalTrials.gov More Metabolic Syndrome trials