Glycemic Response Testing

This study has been completed.

Sponsor:

Collaborator:

Reading Scientific Services Ltd.

Information provided by (Responsible Party):

Mondelēz International, Inc.

ClinicalTrials.gov Identifier:

NCT01536860

First received: February 16, 2012

Last updated: August 30, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 16, 2012

Last Updated Date

August 30, 2012

Start Date ^ICMJE

February 2012

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Glycemic response upon consumption of control and experimental test food products [ Time Frame: 0-120 minutes ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01536860 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Glycemic Response Testing

Official Title ^ICMJE

Glycaemic Response Testing

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Condition ^ICMJE

Glycemic Index
Glycemic Response

Intervention ^ICMJE

Other: Dietary Intervention

300 ml of liquid food product

Study Arm (s)

Placebo Comparator: Control Test Drink
control drink

Intervention: Other: Dietary Intervention
Experimental: Experimental Test Drink 1
control drink containing ingredient 1

Intervention: Other: Dietary Intervention
Experimental: Experimental Test Drink 2
Control drink containing ingredient 2

Intervention: Other: Dietary Intervention

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2012

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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
Not allergic to mustard, dairy or soy
Having a fasting plasma glucose (finger stick) <100 mg/dl (<5.5 mmol/L)
Willing and able to provide written informed consent

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01536860

Other Study ID Numbers ^ICMJE

P12-00794

Has Data Monitoring Committee

Responsible Party

Mondelēz International, Inc.

Study Sponsor ^ICMJE

Mondelēz International, Inc.

Collaborators ^ICMJE

Reading Scientific Services Ltd.

Investigators ^ICMJE

Principal Investigator:

Valerie Hart, SCS, Dip, MICR

RSSL

Information Provided By

Mondelēz International, Inc.

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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