Evaluation of the Effects Associated With the Administration of Akkermansia Muciniphila on Parameters of Metabolic Syndrome
Condition: Metabolic Syndrome x; Glucose Metabolism Disorders; Dyslipidemias; Obesity
MeSH terms: Obesity; Metabolic Syndrome; Dyslipidemias; Metabolic Diseases; Glucose Metabolism Disorders; Syndrome
Study type: Interventional

Summary: 
      Overweight and obesity have reached worldwide epidemic level. Both overweight and obesity are
      characterized by comorbidities such as cardio-metabolic risk factors (i.e., insulin
      resistance, type 2 diabetes, hypertension, dyslipidemia, low-grade inflammation) representing
      a major public health problem. Therefore, it is urgent to find a therapeutic solution to
      target all these metabolic disorders. Among the environmental factors able to influence the
      individual susceptibility to gain weight and to develop metabolic disorders associated with
      obesity, more and more evidence show that the trillions of bacteria housed in our
      gastro-intestinal tract (i.e, gut microbiota) influence host metabolism. The investigators
      recently discovered a putative interesting microbial candidate, namely Akkermansia
      muciniphila (Akk). More exactly, we found that the administration of Akkermansia muciniphila
      reduced body weight gain, fat mass gain, glycemia and inflammatory markers in diet-induced
      obese mice. Moreover, in overweight/obese patients with cardiovascular risk factors subjected
      to a calorie restriction diet (calorie restriction diet for 6 weeks and an additional 6 weeks
      of weight maintenance), a higher abundance of Akkermansia muciniphila was associated with a
      better cardio-metabolic status in these patients. The investigators also discovered that
      patients having more Akkermansia muciniphila in their gut before the calorie restriction
      exhibited a greater improvement in glucose homoeostasis, blood lipids and body composition
      after calorie restriction. These observations suggested that the administration of
      Akkermansia muciniphila in overweight or obese people could be a very interesting therapeutic
      solution. Currently, no human study has investigated the beneficial effects of Akkermansia
      muciniphila administration on obesity and metabolic disorders. The overall objective of this
      study is to evaluate the effects associated with the administration of live or heat-killed
      Akkermansia muciniphila on the metabolic disorders (insulin-resistance, type-2 diabetes,
      dyslipidemia, inflammation) related to overweight and obesity in humans.
    


Intervention name(s): Placebo; Live Akk 9; Live Akk 10; Killed Akk
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of one dose-sachet per day. This dose-sachet contains a placebo (PBS/Glycerol); Consumption of one dose-sachet per day. This dose-sachet contains Live Akkermansia muciniphila (one billion per dose-sachet); Consumption of one dose-sachet per day. This dose-sachet contains Live Akkermansia muciniphila (ten billion per dose-sachet); Consumption of one dose-sachet per day. This dose-sachet contains heat-killed Akkermansia muciniphila
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Gut microbiota; Akkermansia muciniphila