Blood Glucose and Insulin Responses to Snack Food Products

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Determine the Effects of Added Ingredients on Glycaemic and Insulinemic Responses to a Snack Food

Conditions
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Study Focus 1:Glycaemic Index, Study Focus 2:Glycaemic Response, Study Focus 3:Insulinemic Response

Intervention / Treatment
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* Other: Dietary Intervention
* Other: Dietary Intervention
* Other: Dietary Intervention
* Other: Dietary Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Test Food<br>Snack base | Other: Dietary Intervention<br> <br> |
| Experimental: Experimental Test Food 1<br>Snack Base containing ingredient 1 | Other: Dietary Intervention<br> <br> |
| Experimental: Experimental Test Food 2<br>Snack base containing ingredient 2 | Other: Dietary Intervention<br> <br> |
| Experimental: Experimental Test Food 3<br>Snack base containing ingredients 1 and 2 | Other: Dietary Intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic index of experimental test foods compared to that of control test food using venous plasma. |  | 0-120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 insulin in venous plasma |  | 0-180 minutes | 
| Measure C-peptide in venous plasma |  | 0-180 minutes |