Status:
COMPLETED
Clinical Study to Assess the Long-term Effect of Pep2Dia® on Glucose Homeostasis in Prediabetic Subjects
Lead Sponsor:
Ingredia S.A.
Collaborating Sponsors:
BioTeSys GmbH
Conditions:
Prediabetic State
Eligibility:
All Genders
25-70 years
Phase:
NA
Brief Summary
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) befo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2023
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT05391854
Start Date
June 21 2022
End Date
June 20 2023
Last Update
June 28 2023
Active Locations (1)
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1
Biotesys
Esslingen am Neckar, Germany