Glycaemic Response Testing | NCT01536847

Studies
Glycaemic Response Testing

NCT01536847

Sponsor

Mondelēz International, Inc.

Status

Completed

Last Update Posted

Sep 10, 2012Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Glycaemic Index
Glycaemic Response

Interventions

Dietary Intervention
Dietary Intervention
Dietary Intervention

Countries

Not provided

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

Sep 2012

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 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Feb 16, 2012

First Submission Date that Met QC Criteria

Feb 16, 2012

First Posted Date

Feb 22, 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

Sep 7, 2012

Last Update Posted Date

Sep 10, 2012Estimated

Name	Class
Reading Scientific Services 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

The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).

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

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Test Drink	Placebo Comparator	Control drink	Other: Dietary Intervention
Experimental Test Drink 1	Experimental	Control drink containing ingredient 1	Other: Dietary Intervention
Experimental Test Drink 2	Experimental	Control drink containing ingredient 2	Other: Dietary Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietary Intervention	Other	300 ml of liquid food product	Control Test Drink

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glycaemic index of experimental test food using capillary blood		0-120 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female (not less than 40% males or females
Non-smoker
Aged 18 to 55 years
Have a body mass index between 18.5 to 29.99 kg/m2
Healthy, non-diabetic, no gastric bypass surgery
Having a fasting plasma glucose (finger stick) <100 mg/dl (<5.5 mmol/L)
Willing and able to provide written informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Suzana Louth, Dr	RSSL	Principal Investigator

Intervention Browse Module

MeSH Terms

ID	Term
D004035	Diet Therapy

Ancestor Terms

ID	Term
D044623	Nutrition Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided