Pharmacokinetics of Plant-based Ingredient

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: No Plant-based ingredient; Dietary Supplement: Plant-based ingredient added to starchy meal; Dietary Supplement: Plant-based ingredient added to liquid

• Registration Number: NCT02168296
• Lead Sponsor: Unilever R&D

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-29
• Status Verified: 2014-06
• Study Start: 2014-06
• Study First Submitted QC: 2014-06-16
• Study First Posted: 2014-06-20
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2015-02-17
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No added Plant-based ingredient	No Plant-based ingredient	No Plant-based ingredient added to starchy meal
Low dose added to starchy meal	Plant-based ingredient added to starchy meal	Plant-based ingredient in low dose added to starchy meal
High dose added to starchy meal	Plant-based ingredient added to starchy meal	Plant-based ingredient in high dose added to starchy meal
High dose added to liquid	Plant-based ingredient added to liquid	Plant-based ingredient in high dose added to liquid
Low dose added to liquid	Plant-based ingredient added to liquid	Plant-based ingredient in low dose added to liquid

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Urinary excretion of Plant-based ingredient	24 hours
AUC of the plant based ingredient calculated by a compartmental model	predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.

Trial Locations

Locations (1)

Eurofins OPTIMED; 🇫🇷 Giere, France