Study Focus 1:Glycaemic Index, Study Focus 2:Glycaemic Response, Study Focus 3:Insulinemic Response
Conditions
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.
Interventions
OTHERDietary Intervention
Sponsors
Reading Scientific Services Ltd.
Mondelēz International, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycaemic index of experimental test foods compared to that of control test food using venous plasma. | 0-120 minutes |
Secondary
| Measure | 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 |
Countries
United Kingdom
Outcome results
None listed