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CompletedNCT00631293Updated Apr 7, 2009

Study of the Effect of Lactisole on the Intestinal Glucose Uptake

A Phase 1/2 interventional study of lactisole and placebo in Healthy, sponsored by University Ghent. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-04-07.

Sponsored by University Ghent · Phase 1/2, Interventional, and Health services research

Phase
Phase 1/2
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

Study of the effect of lactisole on glucose uptake

02

Conditions studied

  • Healthy

Keywords

  • Healthy volunteers
03

In context

Lead sponsor

University Ghent is the lead sponsor of 349 studies on the registry; 86 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male subject, between 18 and 50 years
  • General good health condition

Exclusion criteria

Exclusion Criteria:

  • Overweight (Body Mass Index ≥30)
  • Metabolic disorders
  • History of gastrointestinal disorders
  • Regular (daily) intake of medication
  • Smoking more than 10 cigarettes/day
  • History of drug abuse
  • Exhaustive (> 3 units/day) alcohol consumption
  • Exhaustive (> 5 units/day) caffeine consumption (coffee, tea, cola, or other caffeine based drinks)
  • Recent (in the last 14 days) donation of blood
  • Recent (in the last 2 days) donation of blood plasma
  • Participation in another trial within 4 weeks before the start of the study
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    1

    administration of lactisole

    Dietary Supplement: lactisole

  • Placebo comparator
    2

    administration of placebo

    Other: placebo

Interventions

  • Dietary supplementlactisole

    administration of lactisole followed by placebo

  • Otherplacebo

    administration of placebo followed by lactisole

06

What researchers measure

Primary outcomes

  1. Differences in glucose uptake rate in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test

    Time frame: 5 weeks

Secondary outcomes

  1. Differences in blood insulin, glucagon, triglycerides, GIP and GLP-1 in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test, ECG

    Time frame: 5 weeks

07

Study locations

1 site
  • University Hospital Ghent
    Ghent, 9000, Belgium
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2008, a primary completion of Apr 2008 and a completion of Apr 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2008
First posted
Mar 7, 2008
Start
Mar 2008
Primary completionActual
Apr 2008
CompletionActual
Apr 2008
Last update
Apr 7, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00631293
Lead sponsor
University Ghent
Collaborators
VIB
First posted
Mar 7, 2008
Start date
Mar 2008
Primary completion
Apr 2008
Completion
Apr 2008
Last update
Apr 7, 2009

Study contacts

Luc Van Bortel, MD, PhD
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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