MedTrace Logo

Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers

NCT02968498 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-03-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Fresenius Kabi

    lead INDUSTRY

Principal Investigators

  • Daniel Menzel, MD · CRO BioTeSys GmbH

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02968498 on ClinicalTrials.gov