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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT07220694
Eligibility Criteria:
Inclusion Criteria:
* Female or male, adults grouped by age as follows :
3 groups of 40 patients each (20 active and 20 placebo)- (age groups - GROUP 1 = aged 35 - 50, GROUP 2 = aged 51-65 and Group 3 = aged 66-80 years.
* In good general health
* Screening fasting glucose 100 to 135 mg/dL
* Screening MoCA less than 26
Exclusion Criteria:
* • Having been diagnosed with known allergies to any ingredients in the study product.
* Relevant history or presence of any medical disorder potentially interfering with this study (e.g., malabsorption, chronic gastro-intestinal diseases, severe depression, cardiovascular disease occurrence within the last 3 months, etc.),
* Regular intake of medications or supplements known to affect glucose tolerance
* Diabetes of any kind
* Breastfeeding, pregnant, or planning to become pregnant during the study according to subject self-report.
* Having a pregnant partner or a partner who is planning to become pregnant during the study period or is unwilling or unable to use an acceptable method of contraception.
* Having a history of skin cancer within the past 5 years.
* Having a history of immunosuppression/immune deficiency disorders (including HIV infection, it has been AIDS, multiple sclerosis, Crohn's disease, rheumatoid arthritis), organ transplant (heart, kidney, etc.), or currently using oral or systemic immunosuppressive medications and biologics (e.g., azathioprine, belimumab, Cimzia®, Cosentyx®, cyclophosphamide, cyclosporine, Enbrel®, Humira®, Imuran®, Kineret®, mycophenolate mofetil, methotrexate, Orencia®, prednisone, Remicade®, Rituxan®, Siliq™, Simponi®, Stelara®, Taltz®) and/or undergoing radiation or chemotherapy as determined by study documentation.
* Currently using or having regularly used corticosteroids (systemic or topical, not nasal or ocular) within the past 4 weeks (including but not limited to betamethasone, clobetasol, desoximetasone, diflorasone, fluocinonide, halcinonide, and halobetasol).
* Having a disease such as asthma, diabetes, epilepsy, hypertension, hyperthyroidism, or hypothyroidism that is not controlled by diet or medication. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc.
* Having started a long-term medication within the last 2 months.
* Having planned surgeries or invasive medical procedures during the study. Noninvasive medical procedures or surgeries will be reviewed for their impact on the study outcome and acceptability by the Investigator or designee.
* Currently participating in any other clinical trial at SFRI or another research facility or doctor's office.
* Having participated in any clinical trial involving the test area within 2 weeks before study enrollment at SFRI or another research facility or doctor's office.
Note - Medications for treatment of chronic diseases that do not affect the metabolism of the study product will be permitted and will be judged individually regarding interference with the study by an investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT07220694
Study Brief:
Protocol Section:
NCT07220694