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Pharmacokinetics of Plant-based Ingredient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168296
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
Unilever R&D

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

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Plant-based ingredient added to starchy meal Dietary Supplement: Plant-based ingredient added to liquid Dietary Supplement: No Plant-based ingredient Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official 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
Study Start Date : June 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168296


Locations
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France
Eurofins OPTIMED
Giere, France
Sponsors and Collaborators
Unilever R&D
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Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT02168296    
Other Study ID Numbers: FDS-NAA-1602
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: June 2014
Keywords provided by Unilever R&D:
Pharmacokinetics
Blood glucose
subjects