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Completed

NCT Number: NCT02168296

Pharmacokinetics of Plant-based Ingredient

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

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Eurofins OPTIMED

Gierre, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Plant-based ingredient added to starchy meal

Dietary Supplement

Plant-based ingredient added to liquid

Dietary Supplement

No plant-based ingredient

Dietary Supplement

Primary outcomes

  1. 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

  1. 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.

  2. Urinary excretion of Plant-based ingredient

    Time frame: 24 hours

Other outcomes

  1. 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.

  2. 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.

  3. +iAUC Blood glucose

    Time frame: 120 minutes and 180 minutes

  4. +iAUC Insulin

    Time frame: 120 minutes and 180 minutes

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Official study title

Exploratory Study to Assess the Pharmacokinetics in Relation to Blood Glucose and Insulin Levels After Intake of a Plant-based Ingredient in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 20, 2014
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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