Efficacy of Glucosanol™ in Reducing Post-prandial Glucose Levels in Overweight Subjects

This is an interventional treatment trial for Hyperglycemia, Postprandial Read More

Inclusion Criteria:

• Caucasian males and females, 18 to 65 years old
• Body mass index (BMI) 25.0-29.9 kg/m2
• Generally in good health
• Normal fasting blood glucose (FBG) 3.9- <5.6 mmol/L (70- <100 mg/dL) and glycated hemoglobin HbA1c of 4- <5.7 %
• Readiness to adhere to consumption of test meals and defined restrictions prior to test meals (refer to section 11.8 for details)

• Readiness to adhere to habitual lifestyle during the study, in particular to:

  1. maintain the same level of physical activity during the study, including non-strenuous transportation to the study visits
  2. if smoking, regular smoking at the same level as prior
• to the study and no smoking on days of test meals
• prior and during the visit
• Stable body weight in the last 3 months prior to V1 (≤5% self-reported change)
• Stable concomitant medications (if any) for at least last 3 months prior to V1

• Women of child-bearing potential only:

  1. negative pregnancy testing (ß-HCG in urine at V1)
  2. commitment to use reliable contraception methods

Exclusion Criteria:

• Known sensitivity to any ingredients / excipients of the IP
• Known food allergy (e.g. to cow's milk, eggs, wheat, crustacean, nuts etc.)
• Clinically relevant excursions of safety parameters
• Digestion/absorption disorders in gastrointestinal (GI) tract (e.g. inflammatory bowel disease)
• Uncontrolled hypertension >140/90 mmHg at V1
• Uncontrolled thyroid disorder at V1
• Any serious condition or disease that renders subjects ineligible
• Change in daily dose of any treatment and/or use of supplements with a possible impact on glycemic control in the last 3 months prior to V1 and throughout the study (refer to section 10 for details)
• Use of any anti-diabetic treatment or use of treatment and/or supplementation, for reduction of blood glucose levels within the last 4 weeks before V1 and throughout the study
• Use of medications or dietary supplements that may influence body weight ≤4 weeks and gastrointestinal functions ≤2 weeks prior to V1 and during the study
• Antibiotic and cortisone therapy ≤2 weeks prior to V1 and during the study
• Vegetarians and subjects with self-reported diet high in fat or protein
• Strenuous exercise within one day prior to each blood glucose sampling (including V1)
• History of bariatric surgery, small bowel resection or extensive bowel resection
• Recent blood donation within ≤1 month prior to study
• Alcohol abuse (men: ≥21 units/week, women: ≥14 units/ week; 1 unit equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits) and any alcohol consumption within 24 h before blood glucose sampling
• Inability to comply with study procedures
• Pregnancy or nursing
• Participation in another study during the last 30 days of the screening visit (V1)
• Any other reason deemed suitable for exclusion, per investigator's judgment