prediabetes R73.9
Conditions
Interventions
Group 1: Food supplement with plant extracts (fenugreek, pomegranate, purslane) with vitamins (thiamine, vitamine B6) and trace elements (Chromium, Zinc, Manganese)
2 x 1 tablets/day (morning and evening), Intervention: 12 weeks
Group 2: Placebo
2 x 1 tablets/day (morning and evening), Intervention: 12 weeks
Sponsors
APOMEDICA Pharmazeutische Produkte GmbH
Eligibility
Sex/Gender
All
Age
25 Years to 70 Years
Inclusion criteria
Inclusion criteria: Main inclusion criteria: - Male and female subjects with prediabetic HbA1c values between 5.7% – 6.4% and/or fasting glucose = 5.6 mmol/L (= 100 mg/dL) and = 6.9 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 - 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: Main Exlusion criteria: - 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 - Known inflammatory and malignant gastrointestinal diseases (i.e. colitis ulcerosa, Morbus Crohn, celiac disease, malignant diseases e.g. colon-cancer, rectum cancer, pancreatitis) - 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 - Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs - Intake of food supplements known to affect glucose tolerance, e.g. cinnamon capsules, conjugated linoleic acids within 4 weeks prior to Visit 1 or during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood glucose (baseline, after 6 and 12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Glycated haemoglobin (HbA1c) ((baseline and 12 weeks) • HOMA-index (baseline, after 6 and 12 weeks) • Fasting insulin (baseline, after 6 and 12 weeks) • Capillary fasting blood glucose measurements (home-based; 3 x 1 week; Baseline, week 6 and week 12) • Blood lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) (baseline, after 6 and 12 weeks) • Sagittal abdominal diameter (SAD) intervention (Baseline, after 6 and 12 weeks) • Body weight (baseline, after 6 and 12 weeks) • Quality of life questionnaire (SF-12) (baseline and 12 weeks) • hsCRP (acute phase protein) (baseline, after 6 and 12 weeks) Subgroup (n=28, randomized(1:1)) additional measurement (baseline and after 12 weeks): : • postprandial assessment of blood glucose increase after intake of a carbohydrate meal: iAUC0-180 min, Delta Cmax, Tmax • Insulin sensitivity index ISI0-120 min • 2h glucose value after mixed meal | — |
Countries
Germany
Contacts
Public ContactChristiane Schön
BioTeSys GmbH
Outcome results
None listed