Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile, Gastric Emptying and GLP-… (NCT06789263) | Clinical Trial Compass
CompletedNot Applicable
Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile, Gastric Emptying and GLP-1 Release in Normoglycemic and Prediabetic Subjects
Germany30 participantsStarted 2025-01-29
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 phosphata…