Proof-of-concept exploratory study
The metabolic syndrome is characterized by a constellation of comorbidities that predispose individuals to an increased risk of developing cardiovascular pathologies, as well as diabetes mellitus type 2.
The intestinal microbiota is a new key contributor involved in the appearance of disorders related to obesity. In humans, studies have provided evidence of a negative correlation between the abundance of Akkermansia muciniphila and overweight, obesity, untreated type 2 diabetes mellitus or hypertension.
Since the administration of A. muciniphila has never been investigated in humans, a randomized, double-blind, placebo-controlled pilot study (published in Nature Medicine) was conducted in insulin-resistant overweight / obese volunteers; 40 were enrolled and 32 completed the trial. The primary end points were safety, tolerability, and metabolic parameters (insulin resistance, circulating lipids, visceral adiposity, and body mass). Secondary outcomes were intestinal barrier function (plasma lipopolysaccharides) and the composition of the intestinal microbiota.
In this single-center study, we demonstrated that daily oral supplementation of A. muciniphila bacteria alive or pasteurized for three months was safe and well tolerated. Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity and reduced insulin and total plasma cholesterol.
Pasteurized supplementation of A. muciniphila slightly decreased body weight compared to the placebo group, and fat mass and hip circumference compared to the baseline. After three months of supplementation, A. muciniphila reduced levels of blood markers relevant to liver dysfunction and inflammation, while the overall structure of the intestinal microbiome was not affected.
In conclusion, this proof-of-concept study shows that the intervention was safe and well tolerated and that supplementation with A. muciniphila improves several metabolic parameters.
More information: Science Daily