Prediabetes, Normoglycemic
Conditions
Keywords
glucose spikes, postprandial glucose, insulin response
Brief 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.
Interventions
DIETARY_SUPPLEMENTCollagen hydrolyzed peptides
Dissolved in flavoured water, single dose, 10 g
OTHERPlacebo
Single dose
Sponsors
Rousselot BVBA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose iAUC | 0-180 minutes postprandially | Area under the curve (AUC) calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration: Glucose-iAUC(0-180minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Cmax | 0-180 minutes postprandially | Maximum blood glucose concentration (Cmax) |
| Delta Cmax | 0-180 minutes postprandially | Maximum increase of blood glucose concentration |
| Tmax | 0-180 minutes postprandially | Time to reach maximum blood glucose concentration (Tmax) |
| Fasting glucose | -30 minutes and 0 minutes prior mixed meal | Fasting glucose |
| Glucose | 120 minutes | Blood glucose concentration after mixed meal |
| Fasting insulin | -30 minutes and 0 minutes prior to mixed meal | Fasting insulin |
| Insulin iAUC | 0-180 minutes postprandially | Area under the curve calculated as the incremental area under the insulin curve |
| C-peptide iAUC | 0-180 minutes postprandially | Area under the curve calculated as the incremental area under the C-peptide curve |
| GLP-1 iAUC | 0-120 minutes postprandially | Incretin response (Glucagon-like Peptide-1) |
| Fasting GLP-1 | -30 minutes and 0 minutes prior mixed meal | Fasting GLP-1 |
| Matsuda-Index | 0-120 minutes postprandially | Determination of Insulin sensitivity |
| Gastric emptying | 0-6 hours postprandially | Time for gastric emptying |
| Satiety assessment | 0-240 minutes postprandially | Visual analog scale (VAS) Scale (0: not at all 100: extremely) |
| Fasting C-peptide | -30 minutes and 0 minutes prior mixed meal | Fasting C-peptide |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal hormones | 0-120 minutes postprandially | Glucose-dependent insulinotropic polypeptide (GIP) |
Countries
Germany
Outcome results
None listed