The Microbes4U® study is the first randomized double-blind placebo-controlled pilot study to evaluate the effects of pasteurized Akkermansia muciniphila administered in humans. The main objectives of the Microbes4U® study were to determine the safety, tolerance and metabolic parameters (i.e., insulin resistance, circulating lipids, visceral adiposity, body mass) after 3 months of daily administration in overweight or obese subjects suffering from metabolic syndrome and insulin resistance. Moreover, the study also looked at the gut barrier function (i.e., plasma lipopolysacharrides) and gut microbiota composition.
Conduct of the study
- a placebo (identical to the active product in form, size, taste and colour)
- ten billion Akkermansia muciniphila bacteria in living form, or
- ten billion Akkermansia muciniphila bacteria in pasteurized form.
The volunteers were also asked to keep their usual dietary habits and physical activities. Before and after the 3 months of supplementation, the following parameters were assessed:
- anthropometric parameters such body weight, waist and hip circumferences
- body composition
- insulin resistance
- gut microbiota composition, and
- gut barrier function.
The results showed that a daily oral supplementation for 3 months of 10 billion bacteria, either alive or pasteurized, was safe and well-tolerated, with excellent compliance. There were no self-reported adverse effects.
Moreover, for the first time, the results from the Microbes4U® study demonstrate that pasteurized Akkermansia muciniphila is able to slow down the progression of metabolic disorders. Compared to the placebo, the daily administration of pasteurized Akkermansia muciniphila:
- significantly reduced insulin resistance (-32.6 ± 6.8% vs placebo; p=0.004);
- significantly reduced insulinemia (-34.1 ± 7.1% vs placebo; p=0.006);
- significantly reduced plasma total cholesterol levels (-8.7 ± 2.4% vs placebo; p=0.02);
- a decreased body weight (-2.3 ± 0.9kg vs placebo; p=0.09);
- decreased waist and hip circumferences (-2.6 ± 1.1cm vs placebo; p=0.09);
- reduced levels of blood markers relevant to liver dysfunction and inflammation;
- significantly decreased plasma lipopolysaccharides levels (-0.9 ± 0.1 EU/ml vs placebo; p= 0.02) (resulting from a reinforcement of the gut barrier function).
In conclusion, the Microbes4U® study highlights that daily administration of pasteurized Akkermansia muciniphila for 3 months is:
- well-tolerated, and
- prevents the deterioration of cardiometabolic health, in terms of pre-diabetes and cardiovascular risks.