Pharmacokinetics of Plant-based Ingredient

Exploratory Study to Assess the Pharmacokinetics in Relation to Blood Glucose and Insulin Levels After Intake of a Plant-based Ingredient in Healthy Subjects

The study is designed to explore the pharmacokinetics of a Plant-based ingredient in two different matrices, at different dose levels.

Inclusion Criteria:

• Healthy males, age at start of the study 20 and 50 years
• Body mass index (BMI) ≥ 20,0 and ≤ 25,0 kg/m2
• Apparently healthy: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases)
• Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening

Exclusion Criteria:

• Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism
• Any history of gastro-intestinal disorders (including frequent diarrhoea for example)
• Blood donation in the past 2 months
• Reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study
• Reported intense sporting activities > 10 h/w
• Consumption of > 21 alcoholic drinks in a typical week
• Not being used to eat breakfast
• Reported use of any nicotine containing products in the six months preceding the study and during the study itself
• Use of medication which interferes with study measurements
• Reported dietary habits: medically prescribed diet, slimming diet
• Not used to eat 3 meals a day
• Vegetarian
• Reported weight loss/gain (>10%) in the last six month before the study;
• Allergy or intolerance to food products and aversion to food products;