Study of the Effect of Lactisole on the Intestinal Glucose Uptake

April 6, 2009 updated by: University Ghent

Study on the Effect of Lactisole on the Intestinal Glucose Uptake

Study of the effect of lactisole on glucose uptake

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
administration of lactisole
Dietary supplement: lactisole
administration of lactisole followed by placebo
Placebo Comparator: 2
administration of placebo
Other: placebo
administration of placebo followed by lactisole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in glucose uptake rate in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test
Time Frame: 5 weeks
5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

VIB

Investigators

  • Principal Investigator: Luc Van Bortel, MD, PhD, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

February 26, 2008

First Submitted That Met QC Criteria

February 27, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

April 7, 2009

Last Update Submitted That Met QC Criteria

April 6, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2008/103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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