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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berberine | Experimental |
| |
| Identical Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berberine | Dietary Supplement | 500 mg berberine (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total |
|
| 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 |
| 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 |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Backes, PharmD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D001599 | Berberine |
| ID | Term |
|---|---|
| D001600 | Berberine Alkaloids |
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Identical Placebo | Other | 500 mg (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |