NCT02968498

Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Fresenius Kabi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Prospective, open, mono-center, randomized, two part study with 4-way cross-over design in each study part. The objective of the study is to investigate blood glucose levels after oral intake of defined amounts of lactulose.

Conditions

• Blood Glucose

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactulose crystals 10 g	White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.
DIETARY_SUPPLEMENT	Lactulose crystals 20 g	White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.
DIETARY_SUPPLEMENT	Lactulose liquid 10 g	Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
DIETARY_SUPPLEMENT	Lactulose liquid 20 g	Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
DIETARY_SUPPLEMENT	Oral glucose 20 g	White crystalline powder used as food ingredient. To standardise for 20 g glucose, 22 g glucose monohydrate will be used. The products will be provided in sachets to be dissolved in 250 mL water.
DIETARY_SUPPLEMENT	Still water	Still water will be used. Water from the same source will be also used to dissolve investigational and control products.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2016-11-18
• Last updated: 2017-03-03

Locations

1 site across 1 country: Germany