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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT06137066
Eligibility Criteria:
Inclusion Criteria:
* Males and females 18-45 years
* BMI between 18.5-30 kg/m2
* No history of smoking or cardiovascular and metabolic diseases (stroke, hypertension, type II diabetes) or other diseases that could impact the study outcomes
* Weight stable (within ±2kg for 6 months)
* Generally healthy as assessed by medical and physical activity questionnaires
* No oral contraceptive use except for triphasic contraceptives
Exclusion Criteria:
* Any concurrent medical, psychiatric, or orthopedic condition that, subject to investigators' discernment, would negatively affect the subject's ability to comply with the study requirements
* Any history of cardiovascular, neurological, respiratory, skeletal muscle or metabolic disease
* Using medication to manage blood glucose or lipid metabolism
* Bleeding disorders or antiplatelet/ anticoagulation therapy
* Currently using (or use within the last 3 months) monophasic or biphasic oral contraceptives
* Currently supplementing with GCE, ALA, or dihydroberberine
* Any known allergies to green coffee extract, alpha-lipoic acid, dihydroberberine or berberine, or supplementing within the last 3 months
* Currently pregnant or lactating
* Have irregular menstrual cycles (\<21 days or \>35 days)
* Any form of cancer currently or in the last 5 years
* Are recreational smokers of any form (tobacco or cannabis)
* Use of corticosteroids, testosterone replacement therapy, or any anabolic steroid
* Not willing to consume the 24-hour control diet prior to metabolic trials
* Any current Illness which could interfere with the study (e.g., prolonged diarrhea, regurgitation, etc.)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06137066
Study Brief:
Protocol Section:
NCT06137066