NCT02168296

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

February 18, 2015

Status Verified

June 1, 2014

Enrollment Period

4 months

First QC Date

April 29, 2014

Last Update Submit

February 17, 2015

Conditions

Healthy

Keywords

PharmacokineticsBlood glucosesubjects

Outcome Measures

Primary Outcomes (1)

  • AUC of the plant based ingredient calculated by a non-compartmental model

    predose, 15min, 30min, 45min, 1h, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.

Secondary Outcomes (2)

  • AUC of the plant based ingredient calculated by a compartmental model

    predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.

  • Urinary excretion of Plant-based ingredient

    24 hours

Other Outcomes (4)

  • AUC of the plant based ingredient calculated by a population model

    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

    predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.

  • +iAUC Blood glucose

    120 minutes and 180 minutes

  • +1 more other outcomes

Study Arms (5)

No added Plant-based ingredient

PLACEBO COMPARATOR

No Plant-based ingredient added to starchy meal

Dietary Supplement: No Plant-based ingredient

Low dose added to starchy meal

ACTIVE COMPARATOR

Plant-based ingredient in low dose added to starchy meal

Dietary Supplement: Plant-based ingredient added to starchy meal

High dose added to starchy meal

ACTIVE COMPARATOR

Plant-based ingredient in high dose added to starchy meal

Dietary Supplement: Plant-based ingredient added to starchy meal

Low dose added to liquid

ACTIVE COMPARATOR

Plant-based ingredient in low dose added to liquid

Dietary Supplement: Plant-based ingredient added to liquid

High dose added to liquid

ACTIVE COMPARATOR

Plant-based ingredient in high dose added to liquid

Dietary Supplement: Plant-based ingredient added to liquid

Interventions

Plant-based ingredient added to starchy mealDIETARY_SUPPLEMENT
High dose added to starchy mealLow dose added to starchy meal
Plant-based ingredient added to liquidDIETARY_SUPPLEMENT
High dose added to liquidLow dose added to liquid
No Plant-based ingredientDIETARY_SUPPLEMENT
No added Plant-based ingredient

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurofins OPTIMED

Gierre, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2014

First Posted

June 20, 2014

Study Start

June 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

February 18, 2015

Record last verified: 2014-06

Locations

FR(1)