Clinical trial NCT01341769: Blood Glucose and Insulin Responses to Snack Food Products
Official title: A Study to Determine the Effects of Added Ingredients on Glycaemic and Insulinemic Responses to a Snack Food
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Study Focus 1:Glycaemic Index
Study Focus 2:Glycaemic Response
Study Focus 3:Insulinemic Response
Lead sponsor: Mondelēz International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Reading Scientific Services Ltd.
First posted: 2011-04-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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:

* 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

Primary outcomes:
measure: Glycaemic index of experimental test foods compared to that of control test food using venous plasma.
timeFrame: 0-120 minutes
Secondary outcomes:
measure: Glycaemic index of experimental test foods compared to that of control test food using capillary blood
timeFrame: 0-120 minutes
measure: Determine and compare glycaemic responses to experimental test foods and control test food using venous plasma and capillary blood
timeFrame: 0-180 minutes
measure: Measure insulin in venous plasma
timeFrame: 0-180 minutes
measure: Measure C-peptide in venous plasma
timeFrame: 0-180 minutes
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Reading Scientific Services Limited
state: Berkshire
Study officials:
affiliation: Reading Scientific Services Limited
name: Valerie Hart, SCS, Dip, MICR
role: STUDY_DIRECTOR
affiliation: Reading Scientific Services Limited
name: Dr. Suzana Louth
role: PRINCIPAL_INVESTIGATOR
References: