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 Healthynormo-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 andduring 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 ofantibiotics) 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 orantipsychotics

• Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mgas standard prophylactic treatment allowed when dose is stable 1 month prior toscreening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowede.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, physicalexamination, clinical laboratory and/or vital signs

• Intake of food supplements known to affect glucose tolerance, e.g., cinnamoncapsules, conjugated linoleic acids

• Drug-, alcohol- and medication abuses

• Pregnant or breast-feeding women