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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: No Plant-based ingredient; Dietary supplement: Plant-based ingredient added to starchy meal; Dietary supplement: Plant-based ingredient added to liquid

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Giere, France
    • Eurofins Optimed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: No added Plant-based ingredient; No Plant-based ingredient added to starchy meal	Dietary supplement: No Plant-based ingredient
Active Comparator: Low dose added to starchy meal; Plant-based ingredient in low dose added to starchy meal	Dietary supplement: Plant-based ingredient added to starchy meal
Active Comparator: High dose added to starchy meal; Plant-based ingredient in high dose added to starchy meal	Dietary supplement: Plant-based ingredient added to starchy meal
Active Comparator: Low dose added to liquid; Plant-based ingredient in low dose added to liquid	Dietary supplement: Plant-based ingredient added to liquid
Active Comparator: High dose added to liquid; Plant-based ingredient in high dose added to liquid	Dietary supplement: Plant-based ingredient added to liquid

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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 Outcome Measures

Outcome 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.
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
+iAUC Insulin	120 minutes and 180 minutes

Collaborators and Investigators

• Sponsor: Unilever R&D

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: June 16, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 17, 2015
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Blood glucose; subjects
• Other Study ID Numbers: FDS-NAA-1602