Metaberine (bio-optimised berberine 200 mg/day) improves metabolic health markers in healthy adults: a randomized, double-blind and placebo-controlled crossover trial
DOI:
https://doi.org/10.18203/2349-3259.ijct20262501Keywords:
Berberine, Biooptimised, GLP-1, Glycemic control, Metabolic health, MetaberineAbstract
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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