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

15 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug berberine for metabolic syndrome?

Research shows that berberine can help lower blood sugar and cholesterol levels, reduce inflammation, and improve insulin resistance in people with metabolic syndrome. It also activates brown fat, which can help with weight management and diabetes. ^{1 2 3 4 5}

Is berberine safe for humans?

Research shows that berberine is generally safe for humans, with some studies noting mild side effects like gastrointestinal issues (stomach-related problems) and muscle-related effects. However, more large-scale and long-term studies are needed to fully understand its safety profile. ^{1 2 3 6 7}

How does the drug berberine differ from other treatments for metabolic syndrome?

Berberine is unique because it activates brown adipose tissue (a type of fat that burns energy) and converts white fat to brown fat, which can help with weight loss and improve metabolism. Unlike many standard treatments, it also has multiple benefits, including lowering blood sugar and cholesterol levels, reducing inflammation, and improving insulin resistance. ^{2 3 5 8 9}

What is the purpose of this trial?

This trial is studying berberine, a plant-based supplement used in traditional Chinese medicine, to see if it can lower cholesterol and blood sugar. The study targets people who prefer not to use prescription medications. Berberine works in a way similar to some common drugs by managing cholesterol and blood sugar levels. Berberine has been used in traditional Chinese medicine for over a thousand years to treat various conditions, including bacterial infections, diabetes, and cardiovascular diseases.

Research Team

James Backes, PharmD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The effects of berberine on inflammatory markers in Chinese patients with metabolic syndrome and related disorders: a meta‑analysis of randomized controlled trials. [2022]

2. Greece pubmed.ncbi.nlm.nih.gov

Effects of berberine on glucose-lipid metabolism, inflammatory factors and insulin resistance in patients with metabolic syndrome. [2020]

3. England pubmed.ncbi.nlm.nih.gov

The effects of Berberis vulgaris L. and Berberis aristata L. in metabolic syndrome patients: a systematic and meta-analysis study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of berberine administration on metabolic syndrome, insulin sensitivity, and insulin secretion. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Berberine is a potential therapeutic agent for metabolic syndrome via brown adipose tissue activation and metabolism regulation. [2020]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Overall and Sex-Specific Effect of Berberine for the Treatment of Dyslipidemia in Adults: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials. [2023]

7. France pubmed.ncbi.nlm.nih.gov

Therapeutic effect of berberine on metabolic diseases: Both pharmacological data and clinical evidence. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Berberine, a Herbal Metabolite in the Metabolic Syndrome: The Risk Factors, Course, and Consequences of the Disease. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Berberine phospholipid exerts a positive effect on the glycemic profile of overweight subjects with impaired fasting blood glucose (IFG): a randomized double-blind placebo-controlled clinical trial. [2023]