Natural Fruit Extract Versus the Assumed Key Active Compound in Reducing the Post-prandial Blood Glucose Level

January 14, 2016 updated by: Unilever R&D

The Bioequivalence of a Natural Extract Versus the Assumed Key Active Compound in Reducing the Post-prandial Blood Glucose Levels

This study is designed to test bioequivalence of a assumed key active compound vs. natural fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for assumed key active compound vs. natural extract falls between 0.8 - 1.25.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The basic study design for this Williams design consists of six distinct treatment sequences; within each of the treatment sequences the treatments are duplicated.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charité Research Organisation GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index (BMI) ≥ 18.5 and ≤ 25.0 kg/m2.
  • Apparently healthy males and females: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery [with exception of cholecystectomy and appendectomy] 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:

  • Use of antibiotics within 3 months before day 1; use of any other medication within 14 days before day 1 except for both paracetamol and hormonal contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Rice only
Other: Placebo
Rice only
Active Comparator: Assumed active
Assumed key active consumed with rice
Other: Assumed active
Assumed key active consumed with rice
Active Comparator: Natural fruit extract
Natural fruit extract consumed with rice
Other: Natural fruit extract
Natural fruit extract consumed with rice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of 2-h Post Prandial Blood Glucose (PPG) based on response to different treatments
Time Frame: 0-2 hours
+iAUC
0-2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of 3-h PPG based on response to different treatments
Time Frame: 0-3 hours
+iAUC
0-3 hours
Change of 2-h and 3-h post-prandial insulin based on response to different treatments
Time Frame: 0-2 hours and 0-3 hours
tAUC
0-2 hours and 0-3 hours
Max plasma concentration for assumed key active
Time Frame: 0-12 hours
Cmax
0-12 hours
Time of max plasma concentration for assumed key active
Time Frame: 0-12 hours
Tmax
0-12 hours
AUC for plasma concentration versus time curve for assumed key active
Time Frame: 0-12 hours
AUC
0-12 hours
Half-life of elimination phase for assumed key active
Time Frame: 0-12 hours
t1/2
0-12 hours
Total amount of assumed key active excreted in urine
Time Frame: 0-36 hours
0-36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unilever R&D

Investigators

  • Principal Investigator: Christian Keicher, Dr, Charité Research Organisation GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 9, 2015

Study Record Updates

Last Update Posted (Estimate)

January 15, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FDS-NAA-2093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe