Clinical trial NCT02168296: Pharmacokinetics of Plant-based Ingredient
Official title: Exploratory Study to Assess the Pharmacokinetics in Relation to Blood Glucose and Insulin Levels After Intake of a Plant-based Ingredient in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Pharmacokinetics
Blood glucose
subjects
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2014-06-20
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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;

Primary outcomes:
measure: AUC of the plant based ingredient calculated by a non-compartmental model
timeFrame: predose, 15min, 30min, 45min, 1h, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.
Secondary outcomes:
measure: AUC of the plant based ingredient calculated by a compartmental model
timeFrame: predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.
measure: Urinary excretion of Plant-based ingredient
timeFrame: 24 hours
Other outcomes:
measure: AUC of the plant based ingredient calculated by a population model
timeFrame: predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.
measure: Describe the time course of the effect on glucose and insulin levels in response to the intake of plant based ingredient
timeFrame: predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.
measure: +iAUC Blood glucose
timeFrame: 120 minutes and 180 minutes
measure: +iAUC Insulin
timeFrame: 120 minutes and 180 minutes
Locations:
city: Giere
country: France
facility: Eurofins OPTIMED
Study officials:
References: