Study of the Effect of Lactisole on the Intestinal Glucose Uptake

This study has been completed.
Sponsor:
Collaborator:
VIB
Information provided by:
University Ghent
ClinicalTrials.gov Identifier:
NCT00631293
First received: February 26, 2008
Last updated: April 6, 2009
Last verified: April 2009
  Purpose

Study of the effect of lactisole on glucose uptake


Condition Intervention Phase
Healthy
Dietary Supplement: lactisole
Other: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Study on the Effect of Lactisole on the Intestinal Glucose Uptake

Further study details as provided by University Ghent:

Primary Outcome Measures:
  • Differences in glucose uptake rate in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: March 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631293

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
VIB
Investigators
Principal Investigator: Luc Van Bortel, MD, PhD University Hospital, Ghent
  More Information

No publications provided

Responsible Party: Dirk Iserentant, PhD, University Ghent
ClinicalTrials.gov Identifier: NCT00631293     History of Changes
Other Study ID Numbers: 2008/103
Study First Received: February 26, 2008
Last Updated: April 6, 2009
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Ghent:
Healthy volunteers

ClinicalTrials.gov processed this record on April 17, 2014