NCT00631293

Brief Summary

Study of the effect of lactisole on glucose uptake

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 7, 2009

Status Verified

April 1, 2009

Enrollment Period

1 month

First QC Date

February 26, 2008

Last Update Submit

April 6, 2009

Conditions

Healthy

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Differences in glucose uptake rate in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test

    5 weeks

Secondary Outcomes (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

    5 weeks

Study Arms (2)

1

EXPERIMENTAL

administration of lactisole

Dietary Supplement: lactisole

2

PLACEBO COMPARATOR

administration of placebo

Other: placebo

Interventions

lactisoleDIETARY_SUPPLEMENT

administration of lactisole followed by placebo

1
placeboOTHER

administration of placebo followed by lactisole

2

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Interventions

lactisole

Study Officials

  • Luc Van Bortel, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 7, 2008

Study Start

March 1, 2008

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 7, 2009

Record last verified: 2009-04

Locations

BE(1)