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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT05575258
Eligibility Criteria:
Inclusion Criteria:
* Age ≥35 and ≤60 years
* BMI ≥25 and ≤35kg/m2
* Weight stable in last 3 months (loss or gain \<4%)
* Hemoglobin A1C (HbA1C ≤6.4%)
* Fasting plasma glucose concentration \<126mg/dl
* For the safety of the participant and proper consent of the procedures, subjects must be able to speak and understand English to participate in this study
* Stable medication/supplement use for 3 months prior to 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
* Strict dietary patterns (e.g., vegan, keto)
* Consuming \>14 alcoholic drinks per week
* Use of cigarettes (or other tobacco products) in last 3 months
* Engaged in high level of competitive exercise (e.g., iron man, marathons, powerlifting)
* Diagnoses of active malignancy, congestive heart failure, diabetes mellitus or chronic obstructive pulmonary disease
* Any inflammatory diseases(e.g., autoimmune diseases, coeliac disease, glomerulonephritis, hepatitis, inflammatory. bowel disease, arthritis)
* Use of antibiotics in last 60 days
* Pregnant or planning to become pregnant in the next 5 months
* Lactating women
* 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
* Participants that are pregnant or planning on becoming pregnant in the next 5 months are excluded. The justification is the documented alterations in metabolism that occur during pregnancy, which would impact our metabolomics analysis in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
60 Years
Study:
NCT05575258
Study Brief:
Protocol Section:
NCT05575258