clinical study to assess the long-term effect of pep2dia® on glucose homeostasis in prediabetic subjects

Conditions: Prediabetic State

Summary: the goal is to assess the long-term effect of pep2dia® compared to placebo intake on blood glucose homeostasis. respective improvements will be assessed by changes in glycated haemoglobin (hba1c) before and after the 12-weeks intervention.


Eligibility criteria:
inclusion criteria: * male and female subjects (minimum one third of each gender) with prediabetic hba1c values between 5.7% and 6.4% and/or fasting glucose ≥ 5.6 mmol/l (≥ 100 mg/dl) and \< 7.0 mmol/l (\< 125 mg/dl) (in venous plasma) (twice confirmed at two independent days if hba1c is \< 5.7%) * age: 25-70 years * body mass index 19-35 kg/m2 * current non-smoker * availability and presence in the study units for approx. 3.5 hours/ week for 2 times. * 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 exclusion criteria: * subjects with diagnosed type 2-diabetes with medical treatment * presence of disease or drug(s) influencing digestion 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) * acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks * 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 * major medical or surgical event requiring hospitalization within the previous 3 months * intake of food supplements known to affect glucose tolerance, e.g., cinnamon capsules, conjugated linoleic acids, omega-3 fatty acids * intake of antibiotics within 4 weeks before the test days * known alcohol abuse or drug abuse * pregnant or breast-feeding women * weight loss intervention or recent body weight change \>5 kg during last 3 months * known or suspected allergy to any component of the investigational product(s) (e.g. milk protein) * blood donation within 4 weeks prior to visit 1 or during the study * anticipating any planned changes in lifestyle for the duration of the study * participation in another clinical intervention study within the last 4 weeks and concurrent participation in another intervention clinical study * subject unable to co-operate adequately