Blood Glucose and Insulin Responses to Snack Food Products

Not Applicable

Withdrawn

• Conditions: Study Focus 1:Glycaemic Index; Study Focus 2:Glycaemic Response; Study Focus 3:Insulinemic Response
• Interventions: Other: Dietary Intervention

• Registration Number: NCT01341769
• Lead Sponsor: Mondelēz International, Inc.

Brief Summary

The purpose of this study is to assess the effects of added food ingredients, when baked into a snack food product, on glycaemic index of the product and glycaemic and insulinemic responses to the product in healthy adults.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-22
• Study First Submitted QC: 2011-04-22
• Study First Posted: 2011-04-26
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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
• Fasting blood glucose (finger-stick) >3.3 and <5.6 mmol/L (Visit 2)
• Two-hour OGTT glucose (finger-stick) <7.8 mmol/L (Visit 2)
• Willing and able to provide written informed consent

Exclusion Criteria

• Females who are lactating or may be pregnant or if of childbearing potential, are not taking adequate contraceptive precautions
• Any significant concurrent illness
• History of allergy likely to interfere with the study or known sensitivity to the test food or its ingredients
• Have assessed an investigational product for GI in the last 72 hours.
• Concurrent participation in any other safety study
• History of diabetes, hepatitis, AIDS, anaemia or a heart condition
• The use of any medication or dietary supplement which might, in the opinion of the principal investigator 1) make participation in the study dangerous to the subject, or 2) may affect the results.
• Had any type of gastrointestinal surgery, including gastric bypass
• Having consumed anything apart from plain water in the 12 hours prior to each test
• Have been medically diagnosed as having high blood pressure or heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental Test Food 1	Dietary Intervention	Snack Base containing ingredient 1
Experimental Test Food 2	Dietary Intervention	Snack base containing ingredient 2
Experimental Test Food 3	Dietary Intervention	Snack base containing ingredients 1 and 2
Control Test Food	Dietary Intervention	Snack base

Primary Outcome Measures

Name	Time	Method
Glycaemic index of experimental test foods compared to that of control test food using venous plasma.	0-120 minutes

Secondary Outcome Measures

Name	Time	Method
Glycaemic index of experimental test foods compared to that of control test food using capillary blood	0-120 minutes
Determine and compare glycaemic responses to experimental test foods and control test food using venous plasma and capillary blood	0-180 minutes
Measure C-peptide in venous plasma	0-180 minutes
Measure insulin in venous plasma	0-180 minutes

Trial Locations

Locations (1)

Reading Scientific Services Limited; 🇬🇧 Reading, Berkshire, United Kingdom