Berberine for Metabolic Syndrome

Overseen By Rebecca Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must not be taking: Statins, Insulin, Steroids, others

Disqualifiers: Diabetes, Heart disease, Alcohol, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests berberine, a plant-based supplement, to determine its effectiveness in lowering cholesterol and blood sugar in people with metabolic syndrome. Metabolic syndrome consists of conditions like high cholesterol, high blood sugar, and large waist size, which increase the risk of heart disease and diabetes. Participants will receive either berberine or a placebo to compare effects. Ideal candidates have high cholesterol and triglycerides (a type of fat in the blood) and meet the criteria for metabolic syndrome. The trial aims to discover if berberine can serve as a natural alternative to prescription medications. As an unphased trial, it offers participants the chance to explore a natural treatment option that could enhance their health and well-being.

Will I have to stop taking my current medications?

Yes, if you are currently taking any medications that alter lipids (fats in the blood) or medications for diabetes, you will need to stop taking them to participate in this trial. The trial excludes participants on these medications.

Is there any evidence suggesting that berberine is likely to be safe for humans?

Previous studies have shown that berberine is safe and well-tolerated. Research suggests it can lower blood sugar and cholesterol without major safety concerns. Some studies mention mild stomach issues, such as an upset stomach, but these are not serious. Overall, berberine appears safe for short-term use, although more research is needed to understand its long-term effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Berberine is unique because it offers a natural alternative to standard treatments for metabolic syndrome, which typically include medications like metformin, statins, or blood pressure drugs. Researchers are excited about berberine because it is derived from plants and has been shown to potentially lower blood sugar, improve cholesterol levels, and reduce inflammation, all of which are crucial for managing metabolic syndrome. Unlike conventional drugs that often target one specific aspect of metabolic syndrome, berberine's multi-faceted approach might provide a more comprehensive treatment with fewer side effects.

What evidence suggests that berberine might be an effective treatment for metabolic syndrome?

Research has shown that berberine, which participants in this trial may receive, can significantly improve the body's management of sugar and fat. It positively affects aspects of metabolic syndrome, such as triglycerides, fasting blood sugar levels, and waist size. Studies indicate that berberine can aid in managing conditions like type 2 diabetes and unhealthy cholesterol or fat levels in the blood. Berberine works similarly to common medications that lower cholesterol and blood sugar. Additionally, berberine may enhance liver function and insulin use, both crucial for managing blood sugar and fat. ^{4 6 7 8 9}

Who Is on the Research Team?

James Backes, PharmD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

Adults over 18 with metabolic syndrome, characterized by certain waist sizes, triglyceride and HDL cholesterol levels, blood pressure, and fasting blood glucose. They must not be on lipid-altering agents or have conditions like diabetes or chronic GI issues that could interfere with the study.

Inclusion Criteria

Your fasting triglyceride level is higher than 300 mg/dL.

I meet at least 3 criteria for metabolic syndrome.

Your current LDL cholesterol level is 80 mg/dL or higher.

Exclusion Criteria

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

I have diabetes with an HbA1c of 6.5% or higher, or my fasting blood sugar is over 126 mg/dL.

I am currently on steroid medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive berberine or placebo to evaluate changes in cholesterol and blood sugar

12 weeks

Monthly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Monthly follow-up questionnaire

What Are the Treatments Tested in This Trial?

Interventions

• Berberine
• Identical Placebo

Trial Overview The trial is testing Berberine's effects on cholesterol and blood sugar compared to a placebo. It aims to determine if Berberine can be an alternative to prescription medications for lowering cholesterol and blood sugar in people who prefer supplements.

How Is the Trial Designed?

Group I: Berberine Experimental Treatment 1 Intervention

Group II: Identical Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12307485/

Efficacy and safety of berberine on the components of ... Berberine significantly improves glucose and lipid metabolism and has notable effects on components of MetS, including TG, FPG, and WC, with a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12016319/

Berberine and health outcomes: an overview of systematic ... Berberine significantly improves type 2 diabetes, gastrointestinal disorders, schizophrenia, metabolic syndrome, and dyslipidemia outcomes.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03976336

Evaluating the Tolerability and Effects of Berberine on ... 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0753332220311768

Therapeutic effect of berberine on metabolic diseases The results showed that the combination of drugs and BBR is better than the drug alone in reducing blood glucose and improving dyslipidemia in patients with ...

5. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-024-05011-2

The clinical efficacy and safety of berberine in ... This meta-analysis demonstrates berberine's efficacy in improving liver enzymes, lipid profile, and insulin sensitivity in NAFLD patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8107691/

Efficacy and Safety of Berberine Alone for Several ... Berberine alone in patients with metabolic disorders can play a good therapeutic effect containing blood lipid-lowering, blood sugar-lowering, ...

7. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1572197/full

Efficacy and safety of berberine on the components ... Conclusion: Berberine significantly improves glucose and lipid metabolism and has notable effects on components of MetS, including TG, FPG, and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8874997/

Berberine, a Herbal Metabolite in the Metabolic Syndrome Unfortunately, despite its beneficial effects and high safety profile, its poor bioavailability is still a limitation in its clinical ...

9. journals.lww.com journals.lww.com/cd/fulltext/2023/06000/efficacy_and_safety_profile_of_berberine_treatment.6.aspx

Efficacy and Safety Profile of Berberine Treatment in... Short-term berberine treatment significantly improved blood glucose and blood lipid profiles without raising safety concerns.