Pharmacokinetics of Plant-based Ingredient

February 17, 2015 updated by: Unilever R&D

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Giere, France
        • Eurofins Optimed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: No added Plant-based ingredient
No Plant-based ingredient added to starchy meal
Active Comparator: Low dose added to starchy meal
Plant-based ingredient in low dose added to starchy meal
Active Comparator: High dose added to starchy meal
Plant-based ingredient in high dose added to starchy meal
Active Comparator: Low dose added to liquid
Plant-based ingredient in low dose added to liquid
Active Comparator: High dose added to liquid
Plant-based ingredient in high dose 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
Time Frame: predose, 15min, 30min, 45min, 1h, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.
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
Time Frame: predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.
predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.
Urinary excretion of Plant-based ingredient
Time Frame: 24 hours
24 hours

Other Outcome Measures

Outcome Measure
Time Frame
AUC of the plant based ingredient calculated by a population model
Time Frame: predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.
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
Time Frame: predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.
predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.
+iAUC Blood glucose
Time Frame: 120 minutes and 180 minutes
120 minutes and 180 minutes
+iAUC Insulin
Time Frame: 120 minutes and 180 minutes
120 minutes and 180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • FDS-NAA-1602

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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