Effect of BGG on Glucose Metabolism and Other Markers of Metabolic Syndrome
Condition: Pre Diabetes
MeSH terms: Metabolic Syndrome; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      According to the International Diabetes Federation, one in every 12 individuals is a diabetic
      (about 8% of the world population). Major risk factors of diabetes are all the aspects of
      modern life which include obesity, over-weight, high-risk behavior like smoking, alcohol,
      multiple drug use-recreational or prescribed, environmental risk factors like inactivity and
      lack of exercise. However there is a window of opportunity between health and disease, which
      is pre-diabetes.

      Pre-diabetes has been defined by American Diabetes Association as Impaired Glucose Tolerance
      (IGT) which is 7.8 -11.0 mmol/l, Impaired Fasting Glucose Test (IFT) which is 5.6-6.9mmol/l
      and now added Glycosylated Hemoglobin (HbA1c) of 5.7% to 6.4%.

      Though there are plenty of drugs available for significantly impaired glucose metabolism
      (including oral hypoglycemic agents and insulin), their use in marginally impaired glucose
      metabolism is questionable due to risk of untoward hypoglycemia.

      On the other hand, herbal products like curcumin, as a single ingredient has poor
      bioavailability problem that restricts its use as standalone treatment. Inulin works as
      pre-biotic and help to maintain gut microbiota which is considered as precursor for progress
      of prediabetes to diabetes. However, it does not have any role in primary pathophysiology of
      impaired glucose metabolism, i.e. pancreatic β cell dysfunction, insulin resistance, hepatic
      gluconeogenesis or intestinal glucose absorption. Resveratrol and omega-3 basically work on
      anti-oxidant pathways.

      None of these popular ingredients has been studied for their role in structural and
      functional health of pancreatic β cells which is very important for prediction of further
      progress of marginally impaired glucose metabolism to significantly impaired glucose
      metabolism.

      It is an unmet need to develop a product which not only improves insulin sensitivity, but
      also help to preserve the structural and functional health of pancreatic β cells. It also
      needs to improve overall metabolic and endothelial health of the person considering the close
      association between impaired glucose metabolism and these parameters.

      The proposed supplement - "Berberine GlucoGold "- is an improved version of successfully
      marketed supplement - Berberine GlucoDefense. It has a balanced composition in which all the
      ingredients complement each other in such a way that along with the individual role in
      glucose metabolism it also takes care of overall bioavailability and stability of the
      supplement. As per the previous data on ingredients, the supplement is also expected to
      preserve the structural and functional health of pancreatic β cells. The ingredients are also
      known to have positive effect on overall metabolic and endothelial health. Thus BGG has been
      developed to address the unmet needs in the area of glucose metabolism and overall metabolic
      health.
    


Intervention name(s): BGG; Placebo
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HbA1c; Pre Diabetes; Berberine