Glycemic Response Testing

Glycemic Response Clinical Trial

Official title:

Glycaemic Response Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536860
• Other study ID #: P12-00794
• Status: Completed
• Phase: N/A
• First received: February 16, 2012
• Last updated: November 5, 2013
• Start date: February 2012
• Est. completion date: March 2012

Study information

• Verified date: November 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 assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2012
• Est. primary completion date: March 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% 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

Study Design

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

Related Conditions & MeSH terms

• Glycemic Index
• Glycemic Response

Intervention

Other:
• Dietary Intervention
300 ml of liquid food product
• Dietary Intervention
300 ml of liquid food product
• Dietary Intervention
300 ml of liquid food product

Locations

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

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	Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products	The individual glucose measurements were collected at baseline (prior to consumption of each test food product and 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of each test food product. The positive incremental area under the time-concentration curve (iAUC) was then calculated for the entire 120 minutes after consumption of each test food product. The results show the differential treatment-related effect on the time-concentration curve (iAUC) for the entire 120 minutes post consumption of each test food product.	0-120 minutes	No