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Study of the Effect of Lactisole on the Intestinal Glucose Uptake

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ClinicalTrials.gov Identifier: NCT00631293
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : April 7, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Study of the effect of lactisole on glucose uptake

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: lactisole Other: placebo Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Study on the Effect of Lactisole on the Intestinal Glucose Uptake
Study Start Date : March 2008
Primary Completion Date : April 2008
Study Completion Date : April 2008
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Differences in glucose uptake rate in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dirk Iserentant, PhD, University Ghent
ClinicalTrials.gov Identifier: NCT00631293     History of Changes
Other Study ID Numbers: 2008/103
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: April 7, 2009
Last Verified: April 2009

Keywords provided by University Ghent:
Healthy volunteers