CompletedNCT02168296Updated Feb 18, 2015

Pharmacokinetics of Plant-based Ingredient

An interventional study of Plant-based ingredient added to starchy meal and Plant-based ingredient added to liquid in Healthy, sponsored by Unilever R&D. Completed at 1 site in France. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-18.

Sponsored by Unilever R&D · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 20 Years to 50 Years
Sex: Male

Study summary

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

Conditions studied

Healthy

Keywords

Pharmacokinetics
Blood glucose
subjects

In context

Lead sponsor

Unilever R&D is the lead sponsor of 69 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 50 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

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

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

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Participant)
Enrollment: 20 participants (actual)

Study arms

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

Interventions

Dietary supplementPlant-based ingredient added to starchy meal
Dietary supplementPlant-based ingredient added to liquid
Dietary supplementNo Plant-based ingredient

What researchers measure

Primary outcomes

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.

Secondary outcomes

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.
Urinary excretion of Plant-based ingredient
Time frame: 24 hours

Other outcomes

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.
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.
+iAUC Blood glucose
Time frame: 120 minutes and 180 minutes
+iAUC Insulin
Time frame: 120 minutes and 180 minutes

Study locations

1 site

Eurofins OPTIMED
Giere, France

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02168296
Lead sponsor: Unilever R&D
Responsible party: Sponsor
First posted: Jun 20, 2014
Start date: Jun 2014
Primary completion: Oct 2014
Completion: Oct 2014
Last update: Feb 18, 2015

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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