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

Sponsor

Unilever R&D (Industry)

Overall Status

Completed

CT.gov ID

NCT02599740

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

41.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Natural fruit extract Other: Assumed active Other: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change of 2-h Post Prandial Blood Glucose (PPG) based on response to different treatments [0-2 hours]
+iAUC

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité Research Organisation GmbH	Berlin		Germany

Sponsors and Collaborators

Unilever R&D

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Unilever R&D

ClinicalTrials.gov Identifier:

NCT02599740

Other Study ID Numbers:

FDS-NAA-2093

First Posted:

Nov 9, 2015

Last Update Posted:

Jan 15, 2016

Last Verified:

Jan 1, 2016

Keywords provided by Unilever R&D

Blood glucose

Study Results

No Results Posted as of Jan 15, 2016