AKK AM06™ Akkermansia muciniphila Postbiotic (Heat-Inactivated AKK Powder)

AM06™ is a heat-inactivated (postbiotic) Akkermansia muciniphila ingredient developed by Guangzhou ZhiYi Biotechnology Co., Ltd. (ZYBio) and supplied under the PROFORCARE® brand. ACC Biotech lists it as a patented next-generation probiotic raw material suitable for tablets, capsules and powder sachets.

Akkermansia muciniphila (AKK) is a mucin-degrading resident of the human gut that uses intestinal mucin as its sole carbon and nitrogen source and typically accounts for 1–5% of the human gut microbiota. It was first isolated from human faeces in 2004; in 2019 the ZYBio team reported the first isolation of AKK from human breast milk.

Published research associates low AKK abundance with obesity, diabetes, hepatic steatosis, inflammation and a weaker response to cancer immunotherapy. AKK is studied mainly for gut-barrier function, weight management, blood glucose control and healthy ageing.

On 9 February 2022 the European Commission adopted Regulation (EU) 2022/168 under Regulation (EC) No 2015/2283, authorising pasteurised (inactivated) Akkermansia muciniphila as a novel food on the EU market. Inactivated AKK is currently the only form of AKK approved for food use in the EU.

The prevailing view in the literature is that inactivated AKK delivers comparable or better biological effect than the live organism while offering a stronger safety profile — which is why AM06™ is supplied as a postbiotic rather than a live culture.

Reported mechanisms: AKK promotes goblet-cell differentiation and mucus production; its short-chain fatty acids bind host receptors and stimulate GLP-1 and GLP-2 secretion, supporting glycaemic control and gut-barrier integrity; the P9 protein and AKK together stimulate GLP-1 through several pathways; AKK drives host production of bioactive lipids that activate PPARα; and AKK together with the membrane protein Amuc_1100 modulates immune-cell differentiation and inflammatory cytokines.

In 2023 the ZYBio team published in Microbiology Spectrum a systematic safety evaluation of 31 Akkermansia muciniphila strains isolated from healthy individuals, covering general characteristics, genetic traits, tolerance, toxicity and whole-genome sequence analysis. AM06 — isolated from human breast milk — was selected as the candidate probiotic for its low toxicity, high genetic stability and strong tolerance to pH and bile salts.

According to the developer, AM06™ is the only commercialised AKK strain sourced from healthy human breast milk, and it carries US FDA Self-GRAS status.

Patent position: 26 patent applications, of which 12 are granted, including 3 PCT applications and 1 US patent.

Supporting evidence package: 9 in vitro and in vivo functional studies, 2 complete toxicology and safety studies, 3 published papers and a completed human clinical trial. Third-party testing is carried out by CNAS-accredited laboratories.

Design: a randomised, double-blind, placebo-controlled trial in adults with obesity and prediabetes, with 12 weeks of supplementation with AM06™ AKK.

Glucose metabolism: fasting blood glucose fell 8.3% (P<0.001) and fasting plasma insulin 39.8% (P<0.05); HOMA-IR, the insulin-resistance index, fell 44.7% (P<0.05). All three reductions were statistically significant versus placebo.

Lipid metabolism: triglycerides fell 10.3% (P<0.05), total cholesterol 6.3% (P<0.05) and LDL cholesterol 4.6% (P<0.05); the reductions in total cholesterol and LDL-C were significant versus placebo.

Body composition: body weight fell 1.72 kg and BMI 0.69 kg/m² (both P<0.001, and P<0.01 versus placebo); total body fat mass fell 1.5 kg (P<0.001, and P<0.05 versus placebo).

Waist measurements: waist circumference fell 6.23 cm and the waist-to-hip ratio 0.07 (both P<0.001 and significant versus placebo). WHR is one of the early predictors of obesity and cardiovascular risk.

Lactate dehydrogenase, an inflammatory marker positively correlated with disordered glucose and lipid metabolism and a risk factor for insulin resistance and type 2 diabetes, also fell significantly versus placebo (P<0.05).

Preclinical support: in animal models both live and inactivated AM06™ reduced body-weight gain and improved disordered glucose metabolism and insulin resistance, with the inactivated form numerically better (no statistically significant difference between the two). In a NAFLD model, inactivated AM06™ clearly improved liver NAS score, liver function, blood lipids, liver-to-body-weight ratio and HOMA-IR.

All figures above are taken from the manufacturer’s technical documentation and published studies, and are provided for raw-material evaluation. They are not a claim about any finished product and do not constitute medical advice; finished-product claims must follow the regulations of the market concerned.

Specifications: ≥1.0 × 10¹¹ cells/g, ≥2.0 × 10¹¹ cells/g or ≥5.0 × 10¹¹ cells/g.

Appearance: white to off-white powder or granules. Dosage forms: tablets, capsules and powders.

Stability: 36-month shelf life at room temperature, which removes the cold-chain requirement that normally applies to live AKK.

Suggested functional positioning: weight management, blood glucose and lipid management, healthy ageing and gut health.

AM06™ is produced on a pharmaceutical-grade live biotherapeutic products (LBP) platform that has passed drug GMP compliance auditing and is operated to US cGMP requirements, with 50 L / 500 L / 10,000 L fermentation capacity. Production materials contain no animal-derived components, so there is no exogenous-agent contamination risk, and residual culture medium and other impurities are tightly controlled. The process uses high-density fermentation followed by precision inactivation.

PROFORCARE® Heat-InActivated technology controls both the lower and the upper temperature limit, holding inactivation temperature within ±2 °C. The result is complete inactivation with no live AKK, an intact cell wall with no loss of membrane proteins, and better preservation of functional proteins than conventional heat treatment.

Postbiotic drug-grade quality control: AKK cell quantification uses ZYBio’s postbiotic drug analytical method, re-verified by China’s National Institutes for Food and Drug Control and accepted by the US FDA; strain identity is confirmed batch by batch by strain-specific PCR; and live-cell testing confirms 100% inactivation, in line with EU and FDA requirements for postbiotic drugs, dietary supplements and foods.