A bio-optimised berberine ingredient has been shown to improve markers of glucose control, endogenous GLP-1 secretion and lipid metabolism at a daily dose of 200 mg, according to a new human clinical trial.
The randomised, double-blind, placebo-controlled crossover study, published in the International Journal of Clinical Trials, evaluated Metaberine — a berberine formulation developed by Zeus Hygia Life Sciences using its BioSOLVE technology.
The trial included 36 healthy adults with a mean age of 39.9 years, a mean BMI of 25.8 and fasting glucose levels of 100-125 mg/dl.
Participants took 200 mg Metaberine or placebo daily for 14 days, followed by a seven-day washout before crossing to the alternative intervention.
The results: improved glucose and GLP-1 response
During a 75 g oral glucose tolerance test, fasting glucose fell by 9.08 mg/dl with Metaberine, compared with 1.36 mg/dl with placebo.
Baseline-corrected glucose area under the curve and maximum concentration also decreased by 13.5% and 12.7%, respectively, with statistically significant reductions reported across the postprandial measurement points.
The ingredient was also associated with increased endogenous GLP-1 secretion, rising by 29% in the fasting state and 22% postprandially versus minimal changes with placebo.
Total cholesterol and LDL-C decreased, while HDL-C increased. No supplement-related adverse events were reported and all 36 participants completed the study.
Tackling berberine’s bioavailability challenge
Berberine has attracted considerable interest in the metabolic health category, with previous meta-analyses reporting improvements in measures including fasting glucose and lipid parameters.
However, its low oral bioavailability has traditionally required relatively high doses of the ingredient.
Zeus Hygia says its BioSOLVE process increases berberine's solubility and absorption, enabling Metaberine to be used at 200 mg/day.
For formulators, the findings add to growing interest in low-dose, bioavailable berberine ingredients as the nutra sector responds to demand for science-backed metabolic health products.
However, it is important to note that the current study was small and short-term, plus its participants were healthy adults with elevated fasting glucose rather than people diagnosed with metabolic disease.
Longer and larger clinical trials will therefore be important in determining the ingredient’s longer-term efficacy and relevance to broader consumer populations.