Reduction of the Dietary Glycemic Index (GI) by L-Arabino... | NCT01039662

Studies
Reduction of the Dietary Glycemic Index (GI) by L-Arabinose and Indigestible Dextrin

NCT01039662

Sponsor

Hiroshima University

Status

Completed

Last Update Posted

Jun 23, 2011Estimated

Enrollment

19Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

L-arabinose and indigestible dextrin
Placebo

Countries

Japan

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

Jun 2011

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

Dec 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Dec 24, 2009

First Submission Date that Met QC Criteria

Dec 24, 2009

First Posted Date

Dec 25, 2009Estimated

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

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Name	Class
Unitika Ltd.	INDUSTRY

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

Description Module

Brief Summary

This study aims to investigate the effect of supplement containing L-arabinose and indigestible dextrin on dietary glycemic index.

Detailed Description

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oolong tea containing L-arabinose and indigestible dextrin	Experimental		Dietary Supplement: L-arabinose and indigestible dextrin
Oolong tea	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
L-arabinose and indigestible dextrin	Dietary Supplement		Oolong tea containing L-arabinose and indigestible dextrin
Placebo

Measure	Description	Time Frame
Postprandial glucose level		2 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy as based on medical history and physical examination
BMI is less or equal to 30 kg/m2
Willing not to serve as blood donor during the study
Informed consent signed

Exclusion Criteria:

Impaired Glucose Tolerance
Female subjects who are pregnant or nursing a child
Participation in any clinical trial up to 90 days before Day 1 of this study
Renal or hepatic dysfunction
Heart disease
Under medication

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hiroshima University		Hiroshima	Hiroshima	734-8551	Japan

Intervention Browse Module

MeSH Terms

ID	Term
D001089	Arabinose

Ancestor Terms

ID	Term
D010429	Pentoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided