Supplementation of YMETA, on Gut Health, Immunity and Metabolism in Pre-diabetic Adult Population
Condition: Pre-diabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      Type 2 diabetes mellitus (T2DM) is a major non-communicable disease and one of the world's
      fastest growing health problems. According to a 2019 report, about 463 million adults
      worldwide currently have diabetes and future projections indicate the number of diabetic
      patients will reach 700 million by 2045.1 T2DM is associated with significant morbidity,
      including increased risk of cardiovascular diseases (CVD) and stroke, hypertension,
      retinopathy and blindness, renal failure, and leg amputation. These place an enormous burden
      on individuals, society and the healthcare system.2

      T2DM is a non-reversible but preventable condition with overweight and obesity being major
      risk factors. The onset of T2DM is gradual, with most individuals progressing from
      normoglycaemia through a pre-diabetic state. People with pre-diabetes, defined as having
      impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or impaired glycated
      haemoglobin (HbA1c),2 are at increased risk of developing T2DM and its associated
      complications, such as CVD and retinopathy, which can develop even in the absence of
      progression to overt T2DM.3-5 Pre-diabetes is a prevalent and potentially reversible
      condition that provides an important window of opportunity for healthcare providers to
      implement interventions that can delay or prevent T2DM and its complications.

      A substantial body of literature has provided evidence for the role of gut microbiota in
      metabolic diseases including type 2 diabetes.6 Indeed, there is evidence for the effects of
      microbiota on glucose metabolism in both preclinical animal models of T2D and in healthy
      animals, by means of increasing the number of inflammatory mediators, chronic inflammation,
      insulin resistance and increased energy intake. Among the commonly reported findings,
      Bifidobacterium spp appears to be the most consistently supported by the literature genus
      containing microbes potentially protective against T2DM. Indeed, nearly all papers report a
      negative association between this genus and T2DM;7-14 while only one paper reported opposite
      results.15

      In view of the correlation between gut microbiota, more specifically Bifidobacterium spp.,
      and diabetes, the Bifidobacterium population and their metabolic action can be taken as an
      important target for interventions to prevent and/or delay the development of T2DM.
    

Detailed description: 
      Y META is a combination of gut health focused bioactives that target both the metabolic
      activity of existing microbiota (Bifidobacterium spp. targeting prebiotic
      galacto-oligosaccharides mixture) and the crosstalk of existing microbiota with host mucosal
      immune system through gut microbiota derived signalling molecules (Bifidobacterium derived
      polysaccharides commercially available as Y SKIN) that interact with the gut mucosal immune
      system to promote its regulatory activity and prevent accumulation of gut derived chronic
      inflammation, in order to revert insulin resistance, the main risk factor for the development
      of T2DM, without the need to modify the microbiota composition with live bacteria.

      In this study, we aim to explore whether a gut health focused intervention, in the form of Y
      META, affect blood glucose level and risk factors for diabetes in pre-diabetic subjects via
      modification of insulin sensitivity and other post-interventional effects.
    

Intervention name(s): YMETA; Placebo control
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 1 sachet containg a total of 3g i.e. 2.5g Galacto-oligosaccharides, 0.5g Bifidobacterium polysaccharides (daily); 3g Maltodextrin (i.e. DE 10) daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment