Metabolic SyndromeNCT03976336
Evaluating the Tolerability and Effects of Berberine on Major Metabolic Biomarkers: A Pilot Study
A study testing Berberine in people with Metabolic Syndrome, run by University of Kansas Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Berberine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2019to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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
- Being tested
- Berberine, Identical Placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerberineDietary supplement
500 mg berberine (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total
Identical PlaceboOther
500 mg (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total
| Study group | Role | What they receive |
|---|---|---|
| Berberine | Experimental | Not described Receives: Dietary Supplement: Berberine |
| Identical Placebo | Placebo comparator | Not described Receives: Other: Identical Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL Cholesterol
LDL cholesterol measured by fasting blood sample
Measured: Baseline to week 12
Change in Hemoglobin A1c
Glucose control as measured by fasting blood sample
Measured: Baseline to week 12
Secondary outcomes (1)
Number of participants with adverse events
Number of participants with adverse events will be measured by a monthly follow-up questionnaire
Measured: Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start20 Aug 2019
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Backes, PharmD, University of Kansas Medical Center
- Investigators
- James Backes, PharmD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976336
- Sponsor's protocol ID
- STUDY00143015
- Status last verified
- Apr 2025
- First submitted
- 3 Jun 2019
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Tolerability and Effects of Berberine on Major Metabolic Biomarkers: A Pilot Study
- ClinicalTrials.gov ID
- NCT03976336
- Acronym / sponsor ID
- STUDY00143015
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Berberine | Experimental | Dietary Supplement: Berberine |
| Identical Placebo | Placebo comparator | Other: Identical Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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):
- Elevated fasting blood glucose ≥100 mg/dL
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berberine500 mg berberine (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total | Dietary supplement | Berberine |
| Identical Placebo500 mg (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total | Other | Identical Placebo |
Primary outcome
Change in LDL Cholesterol
Time frame: Baseline to week 12
LDL cholesterol measured by fasting blood sample
Change in Hemoglobin A1c
Time frame: Baseline to week 12
Glucose control as measured by fasting blood sample
1 secondary outcome
Number of participants with adverse events
Time frame: Week 4, Week 8, and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Backes, PharmD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berberine in people with Metabolic Syndrome, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LDL Cholesterol (time frame: Baseline to week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.