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:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT01063894
Eligibility Criteria:
Inclusion Criteria:
* Subject is willing to maintain their habitual diet and physical activity patterns throughout the study period
* Provision of assent by subject
* Subject's guardian provides informed consent to participate in the study and authorization for release of relevant protected health information to the study investigators
Exclusion Criteria:
* Diagnosis of attention deficit disorder, with or without hyperactivity
* A diagnosis of diabetes mellitus
* Acute illness or use of antibiotics within 5 days of visit
* Subject is a non-breakfast eater defined as not regularly eating food prior to 1000 h
* Known sensitivity or allergy to any ingredients of the study product
* Use of any psychotropic medication within 4 weeks
* Subject did not previously participate in an earlier trial with the same study products
* Exposure to investigational agent within 30 days.
* Individual has a condition the Investigator believes would interfere with his or her ability to provide assent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
12 Years
Study:
NCT01063894
Study Brief:
Protocol Section:
NCT01063894