Pharmacokinetics of Plant-based Ingredient

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

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Plant-based ingredient added to starchy meal
* Dietary Supplement: Plant-based ingredient added to liquid
* Dietary Supplement: No Plant-based ingredient


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No added Plant-based ingredient<br>No Plant-based ingredient added to starchy meal | Dietary Supplement: No Plant-based ingredient<br> <br> |
| Active Comparator: Low dose added to starchy meal<br>Plant-based ingredient in low dose added to starchy meal | Dietary Supplement: Plant-based ingredient added to starchy meal<br> <br> |
| Active Comparator: High dose added to starchy meal<br>Plant-based ingredient in high dose added to starchy meal | Dietary Supplement: Plant-based ingredient added to starchy meal<br> <br> |
| Active Comparator: Low dose added to liquid<br>Plant-based ingredient in low dose added to liquid | Dietary Supplement: Plant-based ingredient added to liquid<br> <br> |
| Active Comparator: High dose added to liquid<br>Plant-based ingredient in high dose added to liquid | Dietary Supplement: Plant-based ingredient added to liquid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood glucose, Pharmacokinetics, subjects