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

• ClinicalTrials.gov Identifier: NCT03976336
• Recruitment Status: Recruiting
• First Posted: June 6, 2019
• Last Update Posted: May 19, 2022
• Sponsor: University of Kansas Medical Center
• Information provided by (Responsible Party): James Backes, PharmD, University of Kansas Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metabolic Syndrome	Dietary Supplement: Berberine; Other: Identical Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Evaluating the Tolerability and Effects of Berberine on Major Metabolic Biomarkers: A Pilot Study
• Actual Study Start Date: August 20, 2019
• Estimated Primary Completion Date: October 2024
• Estimated Study Completion Date: December 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in LDL Cholesterol [ Time Frame: Baseline to week 12 ]
   LDL cholesterol measured by fasting blood sample
2. Change in Hemoglobin A1c [ Time Frame: Baseline to week 12 ]
   Glucose control as measured by fasting blood sample

Secondary Outcome Measures :

1. Number of participants with adverse events [ Time Frame: Week 4, Week 8, and Week 12 ]
   Number of participants with adverse events will be measured by a monthly follow-up questionnaire

Eligibility Criteria

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

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)

Contacts and Locations

Contacts

Contact: Rebecca Study Coordinator; 913-588-2762; rmount2@kumc.edu

Locations

United States, Kansas

University of Kansas Medical Center; Recruiting

Kansas City, Kansas, United States, 66160

Contact: Rebecca Study Coordinator 913-588-2762 rmount2@kumc.edu

Principal Investigator: James Backes, PharmD

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

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

More Information

• Responsible Party: James Backes, PharmD, Professor, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT03976336
• Other Study ID Numbers: STUDY00143015
• First Posted: June 6, 2019
• Last Update Posted: May 19, 2022
• Last Verified: May 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Metabolic Syndrome; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases