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

This study is currently recruiting participants.
Verified April 2013 by Carmel Biosciences
Sponsor:
Collaborator:
Atlanta Vascular Research Foundation
Information provided by (Responsible Party):
Carmel Biosciences
ClinicalTrials.gov Identifier:
NCT01696448
First received: August 13, 2012
Last updated: April 17, 2013
Last verified: April 2013

August 13, 2012
April 17, 2013
August 2012
April 2013   (final data collection date for primary outcome measure)
appetite suppression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in appetite will be measured through food frequency and appetite questionnaires
Same as current
Complete list of historical versions of study NCT01696448 on ClinicalTrials.gov Archive Site
  • Endothelial function using noninvasive brachial artery reactivity (BAR) ultrasound [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Weight control [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Weight will be measured as body weight in lbs and BMI to see if treatment results in weight loss
  • Body Composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Body composition will be measured as body fat percentage, fat mass, fat-free mass and waist to hip ratio.
Same as current
Not Provided
Not Provided
 
The BANGALORE Study; Combination of Berberine, Lipoic Acid, and Picrorhiza
Changes in Appetite, Weight, Body Composition, Endothelial Function and Biomarkers in Patients With the Cardiometabolic Syndrome: Comparison of a Combination of Berberine, Lipoic Acid, and Picrorhiza Versus Placebo (The "BANGALORE" Study)

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 (BLR) 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 BLR) 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 BLR 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

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. Recent reported guidelines by the JNC-VII and National Cholesterol Education Panel/ATP-III suggest that blood pressure reduction is effective in improving the overall quality of life and may be helpful in the prevention of cardiovascular disease.

Diagnosis and treatment of obese patients with hypertension requires that health care providers address the issues of hypertension, glucose intolerance, body weight and dyslipidemia. Strategies to promote therapeutic lifestyle change (TLC), specifically increased physical activity and reduced dietary intake resulting in weight loss, are not as well defined. 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 (BLR) 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.

The investigators will evaluate the initiation of BLR in patients which meet at least 3 of the 5 criteria (ATP-III guidelines) for the cardiometabolic syndrome. The investigators will determine whether the BLR combination as compared to placebo provides benefit in appetite suppression, body composition and certain clinical endpoints, including effects on endothelial function, lipid levels, and glucose control. This study will analyze the effects of 12 week administration of BLR versus placebo on these parameters in a population of patients (n=40) with the cardiometabolic syndrome. The study has a parallel design consisting of 2 weeks of washout and then 12 weeks of treatment to either BLR or placebo. The total study period is 14 weeks. Patients will be assigned to the BLR or placebo group in a 3:1 ratio so that 30 patients will receive BLR and 10 patients will receive placebo. See attached study design.

Primary Objective To assess the comparative effect of a combination (known as BLR) 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 BLR 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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Metabolic Syndrome
  • Dietary Supplement: BLR
    Patients will be randomized to the BLR intervention group in a 3:1, BLR:placebo ratio. There will be 30 patients in the BLR treatment group.
    Other Names:
    • Berberine
    • Alpha-lipoic Acid
    • Picrorhiza
  • Other: Placebo
    Patients will be randomised in a 3:1 ratio. There will be 10 patients in the placebo group.
  • Experimental: Experimental Group
    BLR: 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.
    Intervention: Dietary Supplement: BLR
  • Placebo Comparator: Control Group
    3 placebo capsules, to be taken 3 times a day, 30 minutes before breakfast, lunch and dinner. Total 9 capsules per day.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
April 2013
April 2013   (final data collection date for primary outcome measure)

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 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
Both
18 Years to 80 Years
No
Not Provided
United States
 
NCT01696448
AVR-2012-01
No
Carmel Biosciences
Carmel Biosciences
Atlanta Vascular Research Foundation
Principal Investigator: Syed T Rahman, MD Atlanta Vascular Research Foundation
Carmel Biosciences
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP