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

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Berberine; Other: Identical Placebo

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Study Coordinator; Phone Number: 913-588-2762; Email: rmount2@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Rebecca Study Coordinator; Phone Number: 913-588-2762; Email: rmount2@kumc.edu
      • Principal Investigator: James Backes, PharmD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Berberine	Dietary supplement: Berberine; 500 mg berberine (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total
Placebo Comparator: Identical Placebo	Other: Identical Placebo; 500 mg (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: James Backes, PharmD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2019
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: STUDY00143015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No