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Original Research ArticleInternational Journal of Clinical Trials

Publication:
Metaberine (bio-optimised berberine 200 mg/day) improves metabolic health markers in healthy adults: a randomized, double-blind and placebo-controlled crossover trial

Int J Clin Trials. 2026;13(3):270-282.DOI10.18203/2349-3259.ijct20262501

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Abstract

Background Berberine shows promise for metabolic health but suffers from poor bioavailability requiring high daily doses (500–1500 mg/day) that frequently cause gastrointestinal side effects. We evaluated whether a biooptimised berberine formulation (Metaberine™) developed using BioSOLVE technology could provide meaningful metabolic benefits at substantially lower doses.

Methods In this randomized, double-blind, placebo-controlled crossover trial, 36 healthy adults (mean age 39.9 years, BMI 25.8 kg/m²) with fasting glucose 100–125 mg/dl received Metaberine™ 200 mg or placebo once daily for 14 days per period (7-day washout). Primary outcomes were fasting and postprandial blood glucose during a 75 g oral glucose tolerance test (OGTT) at 0, 30, 60, 90 and 120 minutes. Secondary outcomes included plasma GLP-1, glucose concentration parameters (AUClast, Cmax), lipid profile and safety.

Results Metaberine™ significantly improved all glycemic parameters: fasting glucose decreased by 9.08 mg/dl versus 1.36 mg/dl with placebo (p<0.0001), with significant reductions at all postprandial timepoints. Baseline-corrected glucose AUClast and Cmax decreased by 13.5% and 12.7%, respectively (both p<0.0001). Plasma GLP-1 increased by 29% (fasting) and 22% (postprandial) with Metaberine™ versus minimal change with placebo (both p<0.0001). Lipid profiles improved with decreases in total cholesterol and LDL-C and an increase in HDL-C. Safety was excellent with 100% participant retention and no supplement-related adverse events.

Conclusions These findings demonstrate that biooptimised berberine at 200 mg/day a 5–7-fold lower dose than conventional formulations significantly improve glycemic control, enhances incretin response and favorably modulates lipid metabolism in healthy adults at metabolic risk, supporting its potential as a functional nutritional ingredient for metabolic wellness.

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Affiliations

  1. Zeus Hygia Lifesciences Pvt Ltd, Hyderabad, Telangana, India
  2. BGS Global Institute of Medical Sciences, Bengaluru, Karnataka, India
  3. Nisa Natural Healing, Dindigul, Tamil Nadu, India
  4. Leads Clinical Research and Bio Services Pvt. Ltd., Bengaluru, Karnataka, India

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