Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT01341769
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01341769
Study Brief:
Protocol Section:
NCT01341769