Metabolic SyndromeCAR-191NCT01696448
The BANGALORE Study; Combination of Berberine, Lipoic Acid, and Picrorhiza
A study testing CAR-191 in people with Metabolic Syndrome, run by Carmel Biosciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- CAR-191
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- • 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta Vascular Research Foundation
Atlanta, Georgia, 30342
About this study
Official title: 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 (CAR-191) 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 (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.
Read more
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
Read the detailed description
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 (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.
The investigators will evaluate the initiation of CAR-191 in patients which meet at least 3 of the 5 criteria (ATP-III guidelines) for the cardiometabolic syndrome. The investigators will determine whether the CAR-191 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 CAR-191 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 CAR-191 or placebo. The total study period is 14 weeks. Patients will be assigned to the CAR-191 or placebo group in a 3:1 ratio so that 30 patients will receive CAR-191 and 10 patients will receive placebo. See attached study design.
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
- Being tested
- CAR-191, Placebo
- Keywords
- Appetite Suppression, CAR-191
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-191Dietary supplement
Also called Berberine, Alpha-lipoic Acid, Picrorhiza
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.
PlaceboOther
Patients will be randomised in a 3:1 ratio. There will be 10 patients in the placebo group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
appetite suppression
Change in appetite will be measured through food frequency and appetite questionnaires
Measured: 12 weeks
Secondary outcomes (3)
Endothelial function using noninvasive brachial artery reactivity (BAR) ultrasound
Measured: 12 weeks
Weight control
Weight will be measured as body weight in lbs and BMI to see if treatment results in weight loss
Measured: 12 weeks
Body Composition
Body composition will be measured as body fat percentage, fat mass, fat-free mass and waist to hip ratio.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlanta Vascular Research Foundation
- Responsible party
- Sponsor
- Investigators
- Syed T Rahman, MD, Principal investigator, Atlanta Vascular Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696448
- Sponsor's protocol ID
- AVR-2012-01
- Acronym
- CAR-191
- Status last verified
- Nov 2014
- First submitted
- 13 Aug 2012
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 (CAR-191) Versus Placebo (The "BANGALORE" Study)
- ClinicalTrials.gov ID
- NCT01696448
- Acronym / sponsor ID
- CAR-191 / AVR-2012-01
- Conditions
- Metabolic Syndrome
- Keywords
- Appetite Suppression, CAR-191
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Carmel BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Atlanta Vascular Research Foundation
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 1 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 (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.
The investigators will evaluate the initiation of CAR-191 in patients which meet at least 3 of the 5 criteria (ATP-III guidelines) for the cardiometabolic syndrome. The investigators will determine whether the CAR-191 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 CAR-191 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 CAR-191 or placebo. The total study period is 14 weeks. Patients will be assigned to the CAR-191 or placebo group in a 3:1 ratio so that 30 patients will receive CAR-191 and 10 patients will receive placebo. See attached study design.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: CAR-191CAR-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. |
| Control Group | Placebo comparator | Other: Placebo3 placebo capsules, to be taken 3 times a day, 30 minutes before breakfast, lunch and dinner. Total 9 capsules per day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- • Females of childbearing potential who are pregnant, lactating or who do not employ adequate birth control procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAR-191Also: Berberine, Alpha-lipoic Acid, PicrorhizaPatients 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. | Dietary supplement | Experimental Group |
| PlaceboPatients will be randomised in a 3:1 ratio. There will be 10 patients in the placebo group. | Other | Control Group |
Primary outcome
appetite suppression
Time frame: 12 weeks
Change in appetite will be measured through food frequency and appetite questionnaires
3 secondary outcomes
Endothelial function using noninvasive brachial artery reactivity (BAR) ultrasound
Time frame: 12 weeks
Weight control
Time frame: 12 weeks
Body Composition
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed T Rahman, MD principal investigator
Atlanta Vascular Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAR-191 in people with Metabolic Syndrome, run by Carmel Biosciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
appetite suppression (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.