Microbes4U® Study
The Microbes4U® study is the first randomised double-blind placebo-controlled pilot study to evaluate the effects of pasteurisedAkkermansia muciniphilaadministered in humans.
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Main objectives
To verify the safety of the bacteria.To determine the safety, tolerance and metabolic parameters (i.e. insulin resistance, circulating lipids, visceral adiposity, body mass) after three months of daily administration in overweight or obese subjects suffering from metabolic syndrome and insulin resistance.
To look at the gut barrier function (i.e. plasma lipopolysacharrides) and gut microbiota composition.
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Who participated?
Forty overweight/obese insulin-resistant volunteers were enrolled, of which 32 completed the full study.
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What were participants asked to do?
During the three month study, the volunteers were asked to consume on a daily basis, before their breakfast, depending on their group, either:
- 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 pasteurised form.
The volunteers were also asked to keep their usual dietary habits and physical activities.
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What was assessed?
Before and after the three months of supplementation, the following parameters were assessed:
- anthropometric parameters such body weight, waist and hip circumferences
- body composition
- insulin resistance
- dyslipidaemia
- inflammation
- gut microbiota composition
- gut barrier function
- safety and compliance
What were the results?
Results showed that taking 10 billion bacteria orally every day, whether live or pasteurised, was safe and well tolerated with excellent participant compliance. None of the participants reported any major side effects.
Additionally, for the first time, the results of the Microbes4U® study showed that Akkermansia muciniphila, when pasteurised, has the ability to slow down the progress of metabolic disorders.
Compared to the placebo, taking pasteurisedAkkermansia muciniphiladaily:
- 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).1
Results of the Microbes4U® study
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Key takeaways
The Microbes4U® study highlights that taking pasteurisedAkkermansia muciniphilaevery day for a period of three months is well tolerated and able to improve the cardiometabolic risk profile in overweight/ obese people with insulin resistance.
REFERENCES
- Depommier C, Everard A, Druart C, Plovier H, Van Hul M, Vieira-Silva S, Falony G, Raes J, Maiter
D, Delzenne NM, de Barsy M, Loumaye A, Hermans MP, Thissen JP, de Vos WM, Cani PD (2019)
Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a
proof-of-concept exploratory study. Nat Med 25 (7):1096-1103. doi:10.1038/s41591-019-0495-2.