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

Primary Purpose

Metabolic Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Berberine

Identical Placebo

About this trial

This is an interventional other trial for Metabolic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

University of Kansas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Berberine

Identical Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in LDL Cholesterol

LDL cholesterol measured by fasting blood sample

Change in Hemoglobin A1c

Glucose control as measured by fasting blood sample

Secondary Outcome Measures

Number of participants with adverse events

Number of participants with adverse events will be measured by a monthly follow-up questionnaire

Full Information

NCT ID

NCT03976336

First Posted

June 3, 2019

Last Updated

May 18, 2022

Sponsor

University of Kansas Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03976336

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 20, 2019 (Actual)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Berberine

Arm Type

Experimental

Arm Title

Identical Placebo

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Berberine

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Identical Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in LDL Cholesterol

Description

LDL cholesterol measured by fasting blood sample

Time Frame

Baseline to week 12

Title

Change in Hemoglobin A1c

Description

Glucose control as measured by fasting blood sample

Time Frame

Baseline to week 12

Secondary Outcome Measure Information:

Title

Number of participants with adverse events

Description

Number of participants with adverse events will be measured by a monthly follow-up questionnaire

Time Frame

Week 4, Week 8, and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rebecca Study Coordinator

Phone

913-588-2762

rmount2@kumc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Backes, PharmD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rebecca Study Coordinator

Phone

913-588-2762

rmount2@kumc.edu

First Name & Middle Initial & Last Name & Degree

James Backes, PharmD

12. IPD Sharing Statement

Learn more about this trial

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

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