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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT03983733
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* 18-70 years of age (19 year age minimum in Alabama and Nebraska)
* Body mass index (BMI) between 16.5 and 49.9 kg/m2.
* Living in the continental USA.
* Able and willing to comply with the study protocol and provide informed consent.
Exclusion Criteria:
* Refuse or are unable to provide informed consent to participate in the study.
* Have ongoing, active inflammatory disease or condition e.g. Rheumatoid arthritis, systemic lupus erythematosus, polymyalgia and other connective tissue diseases.
* Have had cancer in the last two years, excluding skin cancer.
* Have been diagnosed with Inflammatory Bowel Disease (ulcerative colitis and Crohn's disease) or Celiac disease (gluten allergy), or any other long-term gastrointestinal disorder that would prevent the individual from safely eating normal US food. Irritable Bowel Syndrome is not an exclusion.
* Have had bariatric or other major gastrointestinal surgery.
* Have been medically advised that eating high-fat meals over a period of a few days might be dangerous.
* Currently suffer from severe anemia or jaundice.
* Have taken any of the following medications in the last three months:
immunosuppressants (including oral steroids) or antiretroviral therapies or antibiotics (excluding topical antibiotics). If diagnosed with non-alcoholic fatty liver disease, use of any steatogenic medications (amiodarone or methotrexate) or insulin in the last 3 months
* Have an uncontrolled intercurrent illness (e.g. hepatitis c, influenza)
* Are using proton pump inhibitors ("PPI"s such as omeprazole and pantoprazole), unless they are able to stop two weeks before the start of the study and abstain from use during the study.
* Have type 1 diabetes.
* Have type 2 diabetes and are taking insulin or sulfonyurea medications (such as Diamicron (Gliclazide), Diamicron MR (Gliclazide), Amaryl (Glimepiride), Daonil (Gilbenclamide or Glyburide), Gibenese (Glipizide), Minodiab (Glipizide), Tolbutamide (Tolbutamide)). For clarity, people with type 2 diabetes can participate if they take metformin or gliptins.
* Have type 2 diabetes and a fasting glucose level of \>216mg/dL. These individuals wil be excluded whether or not they are on medication.
* Started antidepressant medication within the last 3 months, or are currently suffering from acute clinically diagnosed depression which is not well controlled.
* Have had a heart attack (myocardial infarction) or stroke in the last 6 months.
* Are pregnant or breastfeeding, have given birth in the last three months, or are planning to be pregnant in the next 3 months.
* Diagnosed with an eating disorder (e.g. anorexia nervosa or bulimia nervosa)
* Are vegan, or unwilling to consume foods that are part of the study.
* Do not have a mobile phone capable of running the Zoe study/results apps, or are unable to use their phone to operate the apps. As a consequence of this exclusion, all participants must be able to read and write in English, as the app is only available in English.
* Are unable to have continuous access to their smartphone or unable to wear the activity tracker on their arm for the duration of the study, e.g. because their work will not allow it.
* Have a known allergy to adhesives like that used to affix the continuous glucose monitor.
* Are unable or unwilling to visit a Quest center to provide fasting blood samples.
* Do not have access to wifi or unlimited mobile data to allow them to download the app for free and upload data during the study.
* Do not have a freezer to store study-related foods required for the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03983733
Study Brief:
Protocol Section:
NCT03983733