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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03976336
• Other study ID #: STUDY00143015
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2019
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Kansas Medical Center
• Contact: Rebecca Study Coordinator
• Phone: 913-588-2762
• Email: rmount2[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Metabolic Syndrome

Intervention

Dietary Supplement:
• Berberine
500 mg berberine (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total

Other:
• Identical Placebo
500 mg (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LDL Cholesterol	LDL cholesterol measured by fasting blood sample	Baseline to week 12
Primary	Change in Hemoglobin A1c	Glucose control as measured by fasting blood sample	Baseline to week 12
Secondary	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