Pharmacokinetics of Plant-based Ingredient

NCT ID: NCT02168296

Last Updated: 2015-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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No added Plant-based ingredient

No Plant-based ingredient added to starchy meal

Group Type PLACEBO_COMPARATOR

No Plant-based ingredient

Intervention Type DIETARY_SUPPLEMENT

Low dose added to starchy meal

Plant-based ingredient in low dose added to starchy meal

Group Type ACTIVE_COMPARATOR

Plant-based ingredient added to starchy meal

Intervention Type DIETARY_SUPPLEMENT

High dose added to starchy meal

Plant-based ingredient in high dose added to starchy meal

Group Type ACTIVE_COMPARATOR

Plant-based ingredient added to starchy meal

Intervention Type DIETARY_SUPPLEMENT

Low dose added to liquid

Plant-based ingredient in low dose added to liquid

Group Type ACTIVE_COMPARATOR

Plant-based ingredient added to liquid

Intervention Type DIETARY_SUPPLEMENT

High dose added to liquid

Plant-based ingredient in high dose added to liquid

Group Type ACTIVE_COMPARATOR

Plant-based ingredient added to liquid

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Plant-based ingredient added to starchy meal

Intervention Type DIETARY_SUPPLEMENT

Plant-based ingredient added to liquid

Intervention Type DIETARY_SUPPLEMENT

No Plant-based ingredient

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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;
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Unilever R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eurofins OPTIMED

Gierre, , France

Site Status

Countries

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France

Other Identifiers

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FDS-NAA-1602

Identifier Type: -

Identifier Source: org_study_id

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