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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014