effect of a collagen hydrolysate on postprandial blood glucose profile, gastric emptying and glp-1 release in normoglycemic and prediabetic subjects

Conditions: Prediabetes; Normoglycemic

Summary: aim of the study is to investigate the postprandial response on blood glucose, insulin, c-peptide, incretin response and gastric emptying after intake of collagen hydrolysate compared to placebo in normoglycemic and in prediabetic participants. this will be investigated in a cross-over randomized double-blind placebo controlled study design. in an exploratory part ii, timing of intake of collagen hydrolysate in relation to the mixed meal will be investigated in a subgroup of 50% of the participants.


Eligibility criteria:
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 normoglycemic 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 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) * subjects who use an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump. * planned mri during or 4 weeks after the study. * subjects overweighed with abdominal diameter \>140 cm * 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 * drug-, alcohol- and medication abuses * pregnant or breast-feeding women * weight loss intervention or recent body weight change \>5 kg during the last 3 months * blood donation within 4 weeks prior to screeningor plan to donate blood 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 * subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol

Keywords: glucose spikes postprandial glucose insulin response