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 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT04735835
Eligibility Criteria:
Inclusion Criteria:
* Enrolled in the commercial ZOE testing program
* Any sex
* Minimum 18 years of age (minimum 19 years of age in Alabama and Nebraska due to state laws)
* Body mass index (BMI) of greater than or equal to 16.5 kg/m2.
* Living in the continental US states, other than in New York (excluded from the ZOE testing product also as they are unable to access the dried blood spot service provided by Quest), or living in the UK
* Able and willing to comply with the study protocol and provide informed consent.
* Under care for chronic medical conditions (including eating disorders, type 1 diabetes, type 2 diabetes), and confirm they have checked with their primary care physician that this study is safe for them (US cohort only)
Exclusion Criteria:
* Cannot safely eat the pre-made test meals which contain standard US ingredients, e.g. due to allergy or recent gastrointestinal surgery, or are unwilling to consume these foods.
* Are pregnant.
* Have had a heart attack (myocardial infarction), stroke/transient ischemic attack (TIA), or major surgery in the last two months.
* Are unable to read and write in English, as the ZOE app is only available in English.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04735835
Study Brief:
Protocol Section:
NCT04735835