NCT04747639

Glycemic Response to Two Doses of Low Sugar Apple Juice

Double-blind, Randomized, Controlled, Four Treatment Four Period Cross-over Trial on Glycemic Response, Excretion of Gluconate and Tolerability of Two Doses of Low Sugar Apple Juice

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Clinical Research Center Kiel GmbH · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single center, double-blind, randomized controlled cross-over trial with four treatments and four time points. The study has three primary objectives. The first primary objective is to confirm the reduction of postprandial glycemic and insulinemic response after consumption of 500 ml glucose-free apple juice compared to 500 ml untreated apple juice as could be shown in a previous study

Detailed description

Single center, double-blind, randomized controlled cross-over trial with four treatments and four time points. The study has three primary objectives. The first primary objective is to confirm the in a previous study shown reduction of postprandial glycemic and insulinemic response after consumption of 500 ml glucose-free apple juice compared to 500 ml untreated apple juice. The second primary objective is to show the reduction of postprandial glycemic response after consumption of 250 ml glucose-free apple juice compared to 250 ml untreated apple juice. The third primary objective is to show the reduction of insulinemic response after consumption of 250 ml glucose-free apple juice compared to 250 ml untreated apple juice. Secondary objectives include safety aspects, specifically the occurrence of diarrhoea in all four treatment groups, differences between treatment groups on the Bristol Stool Forms Scale, gastro-intestinal symptoms and laboratory parameters. In addition, gluconate excretion and excreted portion of ingested gluconate are of interest as well as faecal pH.

Conditions

• Prediabetes

Interventions

Type	Name	Description
OTHER	500 ml glucose-depleted apple juice
OTHER	500 ml conventional apple juice
OTHER	250 ml glucose-depleted apple juice
OTHER	250 ml conventional apple juice

Timeline

• Start date: 2015-10-28
• Primary completion: 2016-05-09
• Completion: 2021-02-01
• First posted: 2021-02-10
• Last updated: 2021-08-04

Locations

1 site across 1 country: Germany