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

NCT03976336 | Completed

• 1 other identifier: STUDY00143015
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of participants with adverse events

  Week 4, Week 8, and Week 12

Study Arms (2)

Berberine

EXPERIMENTAL

Dietary Supplement: Berberine

Identical Placebo

PLACEBO COMPARATOR

Other: Identical Placebo

Interventions

Berberine DIETARY_SUPPLEMENT

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

Berberine

Identical Placebo OTHER

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

Identical Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Berberine

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• James Backes, PharmD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 6, 2019
• Study Start: August 20, 2019
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)