Clinical Study to Assess the Long-term Effect of Pep2Dia® on Glucose Homeostasis in Prediabetic Subjects

Study Overview
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Brief Summary
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The goal is to assess the long-term effect of Pep2Dia® compared to placebo intake on blood glucose homeostasis. Respective improvements will be assessed by changes in glycated haemoglobin (HbA1c) before and after the 12-weeks intervention.

Official Title
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Clinical Study to Assess the Long-term Effect of Pep2Dia® on Glucose Homeostasis in Prediabetic Subjects: a 12-week Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel Study

Conditions
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Prediabetic State

Intervention / Treatment
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* Dietary Supplement: Pep2dia
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects (minimum one third of each gender) with prediabetic HbA1c values between 5.7% and 6.4% and/or fasting glucose ≥ 5.6 mmol/L (≥ 100 mg/dL) and < 7.0 mmol/L (< 125 mg/dL) (in venous plasma) (twice confirmed at two independent days if HbA1c is < 5.7%) Age: 25-70 years Body mass index 19-35 kg/m2 Current Non-smoker Availability and presence in the study units for approx. 3.5 hours/ week for 2 times. 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 with medical treatment Presence of disease or drug(s) influencing digestion 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) Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks 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 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, omega-3 fatty acids Intake of antibiotics within 4 weeks before the test days Known alcohol abuse or drug abuse Pregnant or breast-feeding women Weight loss intervention or recent body weight change >5 kg during last 3 months Known or suspected allergy to any component of the investigational product(s) (e.g. milk protein) Blood donation within 4 weeks prior to Visit 1 or 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 Subject unable to co-operate adequately

Ages Eligible for Study
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Minimum Age: 25 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pep2dia<br> | Dietary Supplement: Pep2dia<br>* 700 mg Pep2Dia® 15 min prior to breakfast and 700 mg Pep2Dia® 15 min prior to dinner<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* 700 mg placebo 15 min prior to breakfast and 700 mg placebo 15 min prior to dinner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated haemoglobin (HbA1c) | Change from baseline Glycated haemoglobin (HbA1c) at 3 months | Before treatment (baseline = day 0); at the end of the treatment (after 3 months = day 85) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose-iAUC(0-180min) | Area under the curve calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration | Day 1; Day 85 | 
| Cmax | Maximum blood glucose concentration | Day 1; Day 85 | 
| Delta Cmax | Maximum increase of glucose (Cmax minus baseline value) | Day 1; Day 85 | 
| Tmax | Time to reach maximum blood glucose concentration | Day 1; Day 85 | 
| Tbaseline | First time to reach baseline again after increase or decrease in blood glucose | Day 1; Day 85 | 
| ISI 0-120min |  | Day 1; Day 85 | 
| hsCRP |  | Day 1; Day 85 | 
| GLP-1 |  | Day 1; Day 85 | 
| Body composition measurement | Evaluation of the fat mass/lean mass ratio by bioelectrical impedance analysis | Day 1; Day 85 | 
| SF-12 (Short-fom 12) | Score from 12 to 60. Higher score mean a better outcome. | Day 1; Day 85 |