Study of the Effect of Lactisole on the Intestinal Glucos... | NCT00631293

Studies
Study of the Effect of Lactisole on the Intestinal Glucose Uptake

NCT00631293

Sponsor

University Ghent

Status

Completed

Last Update Posted

Apr 7, 2009Estimated

Enrollment

10Estimated

Phase

Phase 1Phase 2

Conditions

Healthy

Interventions

lactisole
placebo

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Feb 26, 2008

First Submission Date that Met QC Criteria

Feb 27, 2008

First Posted Date

Mar 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2009

Last Update Posted Date

Apr 7, 2009Estimated

Name	Class
VIB	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	administration of lactisole	Dietary Supplement: lactisole
2	Placebo Comparator	administration of placebo	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lactisole	Dietary Supplement	administration of lactisole followed by placebo	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Differences in glucose uptake rate in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test		5 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luc Van Bortel, MD, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium

Intervention Browse Module

MeSH Terms

ID	Term
C495512	lactisole

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided