Determination of Glycemic Index (GI) of Ten Food Products | NCT01679704

Studies
Determination of Glycemic Index (GI) of Ten Food Products

NCT01679704

Sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Status

Completed

Last Update Posted

Aug 4, 2014Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Glycemic Index

Interventions

Food products

Countries

Singapore

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

Aug 2014

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

Feb 2012

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Aug 30, 2012

First Submission Date that Met QC Criteria

Sep 5, 2012

First Posted Date

Sep 6, 2012Estimated

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

Aug 1, 2014

Last Update Posted Date

Aug 4, 2014Estimated

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Food products	Other	Ten food products will be given to all subjects	Dietary Supplement: Food products

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Food products	Dietary Supplement		Food products

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glycemic index values of all ten products	Glycemic index values at 120 minutes post adminstration.	120 minutes post adminstration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy non-pregnant females (at least 6 weeks postpartum, non-lactating)
Age between 21 to 60 years

Exclusion Criteria:

Suffering from any chronic diseases.
Suffering from gastrointestinal diseases that may interfere with nutrient absorption, distribution, metabolism and excretion.
History of diabtes mellitus or use of antihyperglycemic drugs or insulin to treat diabetes and related conditions.
History of AIDS, hepatitis, renal or heart disease or any other serious complications that may interfere with glucose metabolism.
Current use of medication that may interfere with the digestion and nutrient absorption (for examples steriods, protease inhibitors or antipsychotics medications).
Current use of medication known to affect glucose tolerance (excluding oral contraceptives).
Known food allergy or intolerance.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kalpana Bhaskaran, Dr	Temasek Polytechnic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Temasek Polytechnic		Singapore			Singapore

Intervention Browse Module

MeSH Terms

ID	Term
D005502	Food

Ancestor Terms

ID	Term
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided