Pre-Diabetes
Conditions
Interventions
Group 1: 40µg Abscisic acid
Group 2: 120 µg Abscisic acid
Group 3: placebo
Sponsors
Anton Hübner GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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%) • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| comparison of placebo versus intervention sdosages cencerning the following parameter: • Maximum blood glucose concentration • Max_increase: Cmax minus baseline value • Tmax: Time to reach maximum blood glucose concentration • Tbaseline: First time to reach baseline again after increase or decrease in blood glucose • AUC(0-180min): Total area under curve from 0 to 180 min for blood glucose concentration • Determination of insulin sensitivity by Matsuda-index • HOMA-index (HOMA-IR and HOMA-beta) • HbA1c • Insulin response (Insulin-iAUC(0-180min)). • further pharmacokinetic data from insulin increase will be calculated (e.g. Cmax, Tmax) • Incretin response in terms of Glucagon-like Peptide-1 (GLP-1): pharmacokinetic data of the 120 min postprandial response (e.g. GLP-1-iAUC(0-120min)) • Glycemic ABA regulation: pharmacokinetic data of the 120 min postprandial response (e.g. ABA-iAUC(0-120min), Cmax, Tmax) (only assessed in case of significance of the primary efficacy variable) • Estimation of whole-body fat mass based on bioelectrical impedance analysis (BIA) and the assessment of waist circumference (WC) and waist-to-hip ratio (WHR) as well as sagittal abdominal diameter (SAD) before and after the 12-weeks intervention • Determination of endothelial function • SF-12 (quality of life) (V1, V3 and V5) • Global assessment optionally the following biomarkers will be anaylzed: • Leptin (blood) • Adiponectin (blood) • hsCRP (blood) • inflammatory biomarkers. | — |
Countries
Germany
Contacts
Public ContactJaqueline Autenrieth
BioTeSys
Outcome results
None listed