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

NCT ID: NCT03976336

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-20
• Study Completion Date: 2025-04-01

Brief Summary

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Berberine

Group Type: EXPERIMENTAL

Berberine

Intervention Type: DIETARY_SUPPLEMENT

500 mg berberine (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total

Identical Placebo

Group Type: PLACEBO_COMPARATOR

Identical Placebo

Intervention Type: OTHER

500 mg (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total

Interventions

Berberine

500 mg berberine (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total

Intervention Type: DIETARY_SUPPLEMENT

Identical Placebo

500 mg (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

James Backes, PharmD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Backes, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

STUDY00143015

Identifier Type: -

Identifier Source: org_study_id