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

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: Healthy
• Intervention / Treatment: Other: Placebo; Other: Assumed active; Other: Natural fruit extract

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

Study Locations

• Germany
  • Berlin, Germany
    • Charité Research Organisation GmbH

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	+iAUC	0-2 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Unilever R&D
• Investigators: Principal Investigator: Christian Keicher, Dr, Charité Research Organisation GmbH

Study record dates

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: Blood glucose
• Other Study ID Numbers: FDS-NAA-2093