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

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03976336

Collaborator

(none)

Enrollment

Location

Arms

63.4

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 20, 2019

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Dec 1, 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

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

Change in LDL Cholesterol [Baseline to week 12]
LDL cholesterol measured by fasting blood sample
Change in Hemoglobin A1c [Baseline to week 12]
Glucose control as measured by fasting blood sample

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

James Backes, PharmD, Professor, University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT03976336

Other Study ID Numbers:

STUDY00143015

First Posted:

Jun 6, 2019

Last Update Posted:

May 19, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metabolic Syndrome

Study Results

No Results Posted as of May 19, 2022