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 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT05690061
Eligibility Criteria:
Inclusion Criteria:
* Age ≥30 and ≤60 years;
* BMI ≥25 and ≤35 kg/m2;
* Weight stable in last 3 months (Loss or gain \<4%);
* Hemoglobin A1C (HbA1C) ≤6.4%;
* Fasting plasma glucose concentration \<126 mg/dl;
* Subjects must be able to speak and understand English to participate in this study
Exclusion Criteria:
* Use of medications that are known to affect the study outcome measures (e.g., NSAIDs, corticosteroids) or increase the risk of study procedures (e.g., anticoagulants) that cannot be temporarily discontinued for this study;
* Consuming \>14 drinks per week;
* Use of cigarettes (or other tobacco products) in last 3 months;
* COVID vaccine within the last two weeks;
* Engaged in high-level competitive exercise (e.g., triathlon, marathon, powerlifting);
* Any inflammatory diseases(e.g. autoimmune diseases, coeliac disease, glomerulonephritis, hepatitis, inflammatory bowel disease, arthritis);
* Diagnoses of active malignancy, congestive heart failure, diabetes mellitus and/or chronic obstructive pulmonary disease;
* Use of antibiotics in last 60 days;
* Pregnant (or planning to in the next month) or lactating women;
* Soy allergy;
* Subjects who the study PI considers unable to safely complete the study protocol;
* Persons who are not able to grant voluntary informed consent;
* Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits;
* Vegetarian
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT05690061
Study Brief:
Protocol Section:
NCT05690061