Blood Glucose and Insulin Responses to Snack Food Products
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Control Test Food Snack base |
Other: Dietary Intervention
|
| Experimental: Experimental Test Food 1 Snack Base containing ingredient 1 |
Other: Dietary Intervention
|
| Experimental: Experimental Test Food 2 Snack base containing ingredient 2 |
Other: Dietary Intervention
|
| Experimental: Experimental Test Food 3 Snack base containing ingredients 1 and 2 |
Other: Dietary Intervention
|
Outcome Measures
Primary Outcome Measures
- Glycaemic index of experimental test foods compared to that of control test food using venous plasma. [0-120 minutes]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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:
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Females who are lactating or may be pregnant or if of childbearing potential, are not taking adequate contraceptive precautions
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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.
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Concurrent participation in any other safety study
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History of diabetes, hepatitis, AIDS, anaemia or a heart condition
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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
- 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Reading Scientific Services Limited | Reading | Berkshire | United Kingdom | RG6 6BZ |
Sponsors and Collaborators
- Mondelēz International, Inc.
- Reading Scientific Services Ltd.
Investigators
- Study Director: Valerie Hart, SCS, Dip, MICR, Reading Scientific Services Limited
- Principal Investigator: Dr. Suzana Louth, Reading Scientific Services Limited
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P10-08857 version 01