Study of the Effect of Lactisole on the Intestinal Glucose Uptake

Healthy Clinical Trial

Official title:

Study on the Effect of Lactisole on the Intestinal Glucose Uptake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631293
• Other study ID #: 2008/103
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 26, 2008
• Last updated: April 6, 2009
• Start date: March 2008
• Est. completion date: April 2008

Study information

• Verified date: April 2009
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Study of the effect of lactisole on glucose uptake

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• lactisole
administration of lactisole followed by placebo

Other:
• placebo
administration of placebo followed by lactisole

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	VIB

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in glucose uptake rate in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test		5 weeks	No
Secondary	Differences in blood insulin, glucagon, triglycerides, GIP and GLP-1 in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test, ECG		5 weeks	Yes