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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT07166835
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to provide written informed consent (in English)
* Aged 18-35
* Male
* Residing at a low altitude (\<500m)
Exclusion Criteria:
* Diagnosed food allergy or intolerance to the investigational products or control products. (Blackcurrant, food allergen/ pine, tree-derived allergen/ l-theanine tree allergen (camellia sinensis))
* Significant past medical and psychiatric history and ongoing chronic conditions such as, cardiovascular disease, respiratory disease, endocrine disorder (e.g. Diabetes mellites) and neurological and psychiatric conditions including brain injury or are colourblind.
* Significant medication history or current prescription of medication or supplements known to affect cognition such as. Sedatives, stimulants, or herbal supplements high in anthocyanin and polyphenol content.
* A positive result from the pre-screening sickle cell trait blood test.
* An abnormal ECG reading.
* A resting heart rate above 100bmp.
* A blood pressure reading above 140/90mmHg.
* Subjects not willing and/ or not able to comply with the scheduled visits required for the study.
* Not willing to provide blood samples.
* Not classified as low risk based on the ACSM guidelines.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT07166835
Study Brief:
Protocol Section:
NCT07166835