NCT02599740

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Unilever R&D · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Natural fruit extract	Natural fruit extract consumed with rice
OTHER	Assumed active	Assumed key active consumed with rice
OTHER	Placebo	Rice only

Timeline

• Start date: 2015-10-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-11-09
• Last updated: 2016-01-15

Locations

1 site across 1 country: Germany