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 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT01943604
Eligibility Criteria:
Inclusion Criteria:
* Children 8-10 years of age will be recruited from Houston, Texas
* Low socio-economic (SES) children and middle income children (defined as those who receive "free" and "reduced fee" lunches from the respective schools within the district)
Exclusion Criteria:
* Children with weights below the 10th percentile and above the 90th percentile will be excluded
* Children will be examined by a trained nurse to rule out color blindness
* Children with a history of neurological, neurodevelopmental, developmental learning disabilities, sensory impairments, mood disorders, attention deficit hyperactivity disorder, acute or chronic medical conditions, reported lactose intolerance, veganism, asthma, tree nut and/or peanut allergy, anemia, pubescent, on prescription medications or a Tanner stage greater than 2 will be excluded from the study
* Subjects who are unwilling to consume Nutella or have dietary restrictions that would prevent them from consuming the prepared meals will not be included
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
10 Years
Study:
NCT01943604
Study Brief:
Protocol Section:
NCT01943604