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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Placebo; Other: Assumed active; Other: Natural fruit extract

• Registration Number: NCT02599740
• Lead Sponsor: Unilever R&D

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.

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Rice only
Assumed active	Assumed active	Assumed key active consumed with rice
Natural fruit extract	Natural fruit extract	Natural fruit extract consumed with rice

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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
Time of max plasma concentration for assumed key active	0-12 hours	Tmax
Max plasma concentration for assumed key active	0-12 hours	Cmax
AUC for plasma concentration versus time curve for assumed key active	0-12 hours	AUC

Trial Locations

Locations (1)

Charité Research Organisation GmbH; 🇩🇪 Berlin, Germany