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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01687569
Other study ID # P12-05774
Secondary ID
Status Completed
Phase N/A
First received September 14, 2012
Last updated May 7, 2013
Start date September 2012
Est. completion date October 2012

Study information

Verified date May 2013
Source Mondelez International, Inc.
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether added ingredient affects glycaemic responses to a cracker snack.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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 wheat, mustard, 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Control Cracker Snack
Base cracker snack
Experimental Cracker Snack 1
Cracker snack containing test ingredient 1
Experimental Cracker Snack 2
Cracker snack containing test ingredient 2

Locations

Country Name City State
United Kingdom Reading Scientific Services Limited (RSSL) Reading,

Sponsors (2)

Lead Sponsor Collaborator
Mondelez International, Inc. Reading Scientific Services Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glycaemic Response(s) to cracker snacks as measured by incremental Area Under the Curve (iAUC) The endpoint will be the blood glucose response curve, calculated from the individual glucose measurements. Evaluated by repeated measures ANOVA on incremental AUC measured in capillary blood. 120 minutes No