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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT02733120
Eligibility Criteria:
Inclusion Criteria Healthy:
* Healthy male or female according to the investigator's or appointed staff's judgment
* Age 16 years or older
* Ability to walk, sit down and stand up independently
* Ability to lie in supine or elevated position for 4 hours
* Willingness and ability to comply with the protocol
Inclusion criteria subjects with Autism Spectrum Disorder (ASD):
* Healthy high functioning person diagnosed with autism spectrum disorder
* Age 16 years or older
* Ability to walk, sit down and stand up independently
* Ability to lie in supine or elevated position for 4 hours
* Willingness and ability to comply with the protocol
Exclusion Criteria:
* Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy group)
* Failure to give informed consent
* Established diagnosis of Insulin Dependent Diabetes Mellitus
* Metabolic diseases, including hepatic or renal disorders
* Presence of acute illness or metabolically unstable chronic illness
* Presence of fever within the last 3 days
* Pre-planned surgery of procedures that would interfere with the conduct of the study
* Any other condition according to the PI or study physician that would interfere with proper conduct of the study / safety of the patient
* Current alcohol or drug abuse
* Use of protein or amino acid containing nutritional supplements within 5 days prior to the study days
* Use of long-term oral corticosteroids or short course of oral cortico-steroids 4 weeks preceding first test day
* Body Mass Index of \< 18.5 or ≥ 40 kg/m2
* Montreal Cognitive Assessment score of \< 20
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT02733120
Study Brief:
Protocol Section:
NCT02733120