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

NCT01696448 | Completed

• 1 other identifier: AVR-2012-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Appetite Suppression; CAR-191

Outcome Measures

Primary Outcomes (1)

• appetite suppression

  Change in appetite will be measured through food frequency and appetite questionnaires

  12 weeks

Secondary Outcomes (3)

• Endothelial function using noninvasive brachial artery reactivity (BAR) ultrasound

  12 weeks

• Weight control

  12 weeks

• Body Composition

  12 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

CAR-191: Berberine 200mg, Alpha-lipoic Acid 150mg, Picrorhiza 100mg each in a separate capsule, to be taken 3 times a day, 30 minutes before breakfast, lunch and dinner. Total 9 capsules per day.

Dietary Supplement: CAR-191

Control Group

PLACEBO COMPARATOR

3 placebo capsules, to be taken 3 times a day, 30 minutes before breakfast, lunch and dinner. Total 9 capsules per day.

Other: Placebo

Interventions

CAR-191 DIETARY_SUPPLEMENT

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.

Also known as: Berberine, Alpha-lipoic Acid, Picrorhiza

Experimental Group

Placebo OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Females of childbearing potential who are pregnant, lactating or who do not employ adequate birth control procedures.
• History of heart failure.
• Stroke or heart attack within past 6 months.
• Use of insulin.
• Non-dominant upper arm circumference greater than 50 cm. (19.5 inches)
• Currently using any prescription or over-the-counter weight loss products
• Previous bariatric surgery or other weight reduction procedures
• Weight loss or gain of greater than 15 pounds in the last 3 months
• Past or current diagnosis of an eating disorder

Sponsors & Collaborators

• Carmel Biosciences: lead
• Atlanta Vascular Research Foundation: collaborator

Study Sites (1)

Atlanta Vascular Research Foundation

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Berberine; Thioctic Acid; Picrorhiza root extract

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Syed T Rahman, MD

  Atlanta Vascular Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: October 1, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

US (1)