Evaluation Series on Safety and Efficacy of Nutritional Supplements
Male or Female aged ≥ 18 years to ≤ 65 years
Newly diagnosed with higher than normal blood sugar levels i.e. Fasting Plasma Glucose of >100 mg/dl, as defined by ADA expert committee on the diagnosis and classification of Pre-Diabetes and Diabetes Mellitus during screening and not on any treatment.
Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures.
Participants on insulin therapy and other oral anti-diabetic agents or having uncontrolled diabetes.
Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.
Impaired renal function as shown by but not limited to Serum Creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female
Clinical evidence of active liver disease or serum alanine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN)
Pregnancy or lactating women
Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol