Healthy, Prediabetic State
Conditions
Keywords
collagen peptides, blood sugar modifying
Brief summary
To investigate the effect of two different dosages collagen hydrolysate (CH) on postprandial blood glucose and insulin profile in prediabetic and normo-glycaemic subjects.This will be investigated in a cross-over randomized double-blind placebo controlled study design.
Interventions
DIETARY_SUPPLEMENTCollagen hydrolysate
Single dose
OTHERPlacebo
Single dose
Sponsors
Rousselot BVBA
BioTeSys GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
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 Healthy normo-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 and during 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 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) * Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs * 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
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 iAUC | 0-240 minutes postprandially | Area under the curve calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration: Glucose-iAUC(0-240minutes) |
| 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) |
| T baseline | 0-240 minutes postprandially | First time to reach baseline again after increase or decrease in blood glucose |
| Matsuda-Index | 0-120 minutes postprandially | Determination of Insulin sensitivity |
| Glucose dip | 0-240 minutes postprandially | maximum dip below baseline and time point of glucose dip |
| Insulin iAUC | up to 0-240 minutes postprandially | Area under the curve calculated as the incremental area under the insulin curve |
| GLP-1 | 0-120 minutes postprandially | Incretin response (Glucagon-like Peptide-1) |
| Satiety assessment | 0-240 minutes postprandially | Visual analog scale (VAS) Scale (0: not at all 100: extremely) |
Countries
Germany
Contacts
STUDY_DIRECTORNicoletta Virgilio, PhD
Rousselot BV
Outcome results
None listed