Status:
COMPLETED
Investigation of Milk Peptides (Pep2Dia®) on Postprandial Blood Glucose Profile 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 investigate the 180 min postprandial response on blood glucose and insulin levels after intake of Pep2Dia® in two different dosages compared to placebo in the context of a meal challeng...
Detailed Description
From a previous pilot study (BTS1130/17) there is first evidence that the native whey product with alpha-glucosidase inhibiting properties (Pep2Dia®) has the potential to modulate postprandial hypergl...
Eligibility Criteria
Inclusion
- Male and female subjects (minimum one third of each gender) with prediabetic HbA1c values between 5.7% - 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%)
- Body mass index 19-35 kg/m2
- Non-smoker
- Caucasian
- Availability and presence in the study units for approx. 3.5 hours/ week for 3 times.
- Signed informed consent form
- No changes in food habits or physical activity 3 months prior to screening and during the study
Exclusion
- Presence of disease or drug(s) influencing digestion and absorption of nutrients or bowel habits
- Intake of medications known to affect glucose tolerance, e.g., diabetic medication, steroids, protease inhibitors or antipsychotics
- Diagnosed Typ 2-Diabetics with medical treatment
- 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, renal or cardiac disease
- Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
- Known inflammatory and 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 antibiotics within 4 weeks before the test days
- Known alcohol abuse or drug abuse
- Pregnant or breast feeding women
- Known or suspected allergy to any component of the investigational product(s) (e.g. milk protein)
- Known HIV-infection
- Known acute or chronic hepatitis B and C infection
- Blood donation within 4 weeks prior to visit 1 or during the study
- Subject unable to co-operate adequately
Key Trial Info
Start Date :
May 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04375449
Start Date
May 4 2020
End Date
December 15 2020
Last Update
May 11 2022
Active Locations (1)
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1
Biotesys
Esslingen am Neckar, Germany