Healthy
Conditions
Keywords
Pharmacokinetics, Blood glucose, subjects
Brief summary
The study is designed to explore the pharmacokinetics of a Plant-based ingredient in two different matrices, at different dose levels.
Interventions
DIETARY_SUPPLEMENTPlant-based ingredient added to starchy meal
DIETARY_SUPPLEMENTPlant-based ingredient added to liquid
DIETARY_SUPPLEMENTNo Plant-based ingredient
Sponsors
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC of the plant based ingredient calculated by a non-compartmental model | predose, 15min, 30min, 45min, 1h, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs. |
Secondary
| Measure | Time frame |
|---|---|
| AUC of the plant based ingredient calculated by a compartmental model | predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs. |
| Urinary excretion of Plant-based ingredient | 24 hours |
Other
| Measure | Time frame |
|---|---|
| AUC of the plant based ingredient calculated by a population model | predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs. |
| +iAUC Insulin | 120 minutes and 180 minutes |
| Describe the time course of the effect on glucose and insulin levels in response to the intake of plant based ingredient | predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs. |
| +iAUC Blood glucose | 120 minutes and 180 minutes |
Countries
France
Outcome results
None listed