Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile in Prediabetic and Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Study to Assess the Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile in Prediabetic and Healthy Subjects: Randomized, Double-blind, Placebo-controlled, Cross-over Study With Different Dosages

Conditions
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Healthy, Prediabetic State

Intervention / Treatment
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* Dietary Supplement: Collagen hydrolysate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collagen hydrolysate dose 1<br>Source: porcine; standardized to 10 g provided as single dose. Orally applied in flavoured water. | Dietary Supplement: Collagen hydrolysate<br>* Single dose<br>|
| Experimental: Collagen hydrolysate dose 2<br>Source: porcine; standardized to 5 g provided as single dose. Orally applied in flavoured water. | Dietary Supplement: Collagen hydrolysate<br>* Single dose<br>|
| Placebo Comparator: Placebo<br>Flavoured water | Other: Placebo<br>* Single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose iAUC | 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) | 0-180 minutes postprandially | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose iAUC | 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) | 0-240 minutes postprandially | 
| Glucose Cmax | Maximum blood glucose concentration (Cmax) | 0-180 minutes postprandially | 
| Delta Cmax | Maximum increase of blood glucose concentration | 0-180 minutes postprandially | 
| Tmax | Time to reach maximum blood glucose concentration (Tmax) | 0-180 minutes postprandially | 
| T baseline | First time to reach baseline again after increase or decrease in blood glucose | 0-240 minutes postprandially | 
| Matsuda-Index | Determination of Insulin sensitivity | 0-120 minutes postprandially | 
| Glucose dip | maximum dip below baseline and time point of glucose dip | 0-240 minutes postprandially | 
| Insulin iAUC | Area under the curve calculated as the incremental area under the insulin curve | up to 0-240 minutes postprandially | 
| GLP-1 | Incretin response (Glucagon-like Peptide-1) | 0-120 minutes postprandially | 
| Satiety assessment | Visual analog scale (VAS) Scale (0: not at all 100: extremely) | 0-240 minutes postprandially | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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collagen peptides, blood sugar modifying