Glycaemic Response to a Liquid Meal Tolerance Test | NCT01682174

Studies
Glycaemic Response to a Liquid Meal Tolerance Test

NCT01682174

Sponsor

Mondelēz International, Inc.

Status

Completed

Last Update Posted

May 9, 2013Estimated

Enrollment

13Actual

Phase

Not Applicable

Conditions

Glycaemic Index
Glycaemic Response

Interventions

Control Drink
Experimental Drink

Countries

United Kingdom

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

May 2013

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

Sep 2012

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Sep 6, 2012

First Submission Date that Met QC Criteria

Sep 6, 2012

First Posted Date

Sep 10, 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

May 7, 2013

Last Update Posted Date

May 9, 2013Estimated

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 glycaemic 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

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Test Drink	Placebo Comparator	control drink	Other: Control Drink Other: Experimental Drink
Experimental Test Drink	Experimental	Experimental Drink	Other: Control Drink Other: Experimental Drink

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Control Drink	Other		Control Test Drink Experimental Test Drink
Experimental Drink

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glycaemic response (incremental area under the curve) of experimental test food using capillary blood		120 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female (not less than 40% Male)
Aged 18 - 55 years
Non Smokers
Have a body mass index between 18.5 to 29.99 kg/m2
Healthy, non-diabetic, no gastric bypass surgery
Not allergic to dairy, or soy
Have 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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rungano Munyuki	RSSL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reading Scientific Services Limited (RSSL)		Reading	Berkshire		United Kingdom