Evaluating the Tolerability and Effects of Berberine on Major Metabolic Biomarkers: A Pilot Study

Study Overview
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Brief Summary
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Berberine is a dietary supplement that comes from the roots, stems, and bark of various plants and has been used for centuries in traditional Chinese medicine. It may help lower cholesterol, lower blood sugar, and reduce inflammation.Very few studies have been done in the United States to show how berberine effects cholesterol and blood sugar. This study is looking to see how berberine changes cholesterol and blood sugar, and to see how well it is tolerated.Berberine is not a prescription medication but it appears to have similar actions to common prescription medications to lower cholesterol like statins, and to lower blood sugar like metformin. We are studying berberine to see if it may be a good option for people that do not want to take prescription medications.

Official Title
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Evaluating the Tolerability and Effects of Berberine on Major Metabolic Biomarkers: A Pilot Study

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Berberine
* Other: Identical Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years and older Current LDL-C of ≥80 mg/dL or higher Current fasting triglyceride level of ≥300 mg/dL Meets current criteria for metabolic syndrome (≥3 of the following): Waist circumference ≥ 35 female or ≥40 for male: Triglycerides ≥ 150 mg/dL: Low HDL-c <40 mg/dL male or <50 mg/dL female: Elevated blood pressure ≥ 130/85 mmHg (or on BP medication): Elevated fasting blood glucose ≥100 mg/dL A male or a non-pregnant female Mentally competent to understand study rationale and protocol Able to speak and read English Exclusion Criteria: Currently taking any lipid-altering agents including but not limited to statins, niacin (>500 mg), bile-acid sequestrants, ezetimibe, fibrates, and Omega-3 fish/krill oils (>1000 mg EPA/DHA). Prior evidence of a vascular event (e.g. stroke, myocardial infarction, revascularization, peripheral vascular disease) Current use of any oral hypoglycemia agent or parenteral medication for diabetes mellitus (e.g. GLP-1 agonists, insulin) Currently taking any drugs with the potential to interact with berberine, including but not limited to cyclosporine, simvastatin, lovastatin, metformin, saquinavir, darunavir, tacrolimus, sirolimus. Previous history of diabetes mellitus, HbA1c ≥ 6.5%, or FPG > 126 mg/dL Chronic disease involving, hepatic, renal, or coronary heart disease, systemic infection (e.g. HIV) or organ transplantation Currently taking systemic steroidal drugs Dependence on alcohol (> 10 drinks per week) or illicit drugs Pregnant or lactating Participation in any other clinical trial within the last 30 days Presence of any medical or psychological condition that in the opinion of the investigator will compromise safe subject participation for the duration of the study Acute or chronic GI conditions (e.g. irritable bowel syndrome, ulcerative colitis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Berberine<br> | Dietary Supplement: Berberine<br>* 500 mg berberine (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total<br>|
| Placebo Comparator: Identical Placebo<br> | Other: Identical Placebo<br>* 500 mg (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL Cholesterol | LDL cholesterol measured by fasting blood sample | Baseline to week 12 | 
| Change in Hemoglobin A1c | Glucose control as measured by fasting blood sample | Baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | Number of participants with adverse events will be measured by a monthly follow-up questionnaire | Week 4, Week 8, and Week 12 |