Clinical dose-finding study to assess the effect of ABAlifeTM on postprandial blood glucose profile in prediabetic subjects: randomized, multicentric, double-blind, placebo-controlled, cross-over study with different dosages combined with a 12-weeks follow-up phase
- Conditions
- Pre-Diabetes
- Registration Number
- DRKS00026093
- Lead Sponsor
- Anton Hübner GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 61
•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%)
•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 (Visit 1 and Visit 2) and approx. 4.5 hours/ week for 2 times (Visit 3 and Visit 5).
•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
•Subjects with diagnosed Type 2 Diabetes mellitus 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 (e.g. CKD stage =4) 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
•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
•Intake of antibiotics within 4 weeks before the test days
•Drug-, alcohol- and medication abuses
•Pregnant or breast-feeding women
•Weight loss intervention or recent body weight change >5 kg during last 3 months
•Diet high in vegetables and fruits =5 portions per day
•Vegan lifestyle
•Known or suspected allergy to any component of the investigational product(s) (e.g. figs)
•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
•Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method comparison of area under the curve calculated, as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration: Glucose-iAUC(0-180min) from placebo and intervention dosages
- Secondary Outcome Measures
Name Time Method