Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile in Prediabetic and Healthy Subjects

Main Inclusion Criteria: Prediabetic subjects: Male and female subjects with prediabetic HbA1c values between 5.7% and 6.4% and/or fasting glucose ≥ 100 mg/dL and ≤ 125 mg/dL (in venous plasma) (twice confirmed at two independent days if HbA1c is < 5.7%) or Healthy normo-glycaemic subjects: fasting glucose <100 mg/dL and HbA1c is < 5.7% Age: 18-70 years Body mass index 19-35 kg/m2 Current Non-smoker Signed informed consent form No changes in food habits or physical activity 3 months prior to screening and during the study If applicable, stable intake of chronic medication of at least 4 weeks Main Exclusion Criteria: Subjects with diagnosed Type 2 Diabetes mellitus with medical treatment Presence of disease or drug(s) influencing digestion (incl. recent intake of antibiotics) and absorption of nutrients Intake of medications known to affect glucose tolerance, e.g., diabetic medication, SGLT-2 inhibitors, GLP-1 receptor agonists, steroids, protease inhibitors or antipsychotics Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening)), which in the Investigator's opinion would impact patient safety Severe liver or renal disease or laboratory evidence of hepatic dysfunction (i.e. alkaline phosphatase, ALT, AST >3 x ULN) Known inflammatory or malignant gastrointestinal diseases (i.e. colitis ulcerosa, Morbus Crohn, celiac disease, malignant diseases e.g. colon-cancer, rectum cancer, pancreatitis) Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs Intake of food supplements known to affect glucose tolerance, e.g., cinnamon capsules, conjugated linoleic acids Drug-, alcohol- and medication abuses Pregnant or breast-feeding women