Study Focus 1:Glycaemic Index Clinical Trial
Official title:
A Study to Determine the Effects of Added Ingredients on Glycaemic and Insulinemic Responses to a Snack Food
| Verified date | January 2019 |
| Source | Mondelez International, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | July 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| 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 - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Reading Scientific Services Limited | Reading | Berkshire |
| Lead Sponsor | Collaborator |
|---|---|
| Mondelez International, Inc. | Reading Scientific Services Ltd. |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Glycaemic index of experimental test foods compared to that of control test food using venous plasma. | 0-120 minutes | ||
| Secondary | Glycaemic index of experimental test foods compared to that of control test food using capillary blood | 0-120 minutes | ||
| Secondary | Determine and compare glycaemic responses to experimental test foods and control test food using venous plasma and capillary blood | 0-180 minutes | ||
| Secondary | Measure insulin in venous plasma | 0-180 minutes | ||
| Secondary | Measure C-peptide in venous plasma | 0-180 minutes |