- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02168296
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
Status
Completed
Conditions
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
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|
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
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+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
Keywords
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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