Status:
ENROLLING_BY_INVITATION
Effects of Sabroxy® Supplementation on Insulin Resistance and Cognitive Function in Adults With Mild Cognitive Impairment and Insulin Resistance
Lead Sponsor:
SF Research Institute, Inc.
Collaborating Sponsors:
Sabinsa Corporation
Conditions:
Insulin Resistance
Mild Cognitive Impairment
Eligibility:
All Genders
35-80 years
Phase:
NA
Brief Summary
This randomized, double-blind, placebo-controlled, 8-week clinical trial is designed to evaluate the effects of Sabroxy®, a standardized extract of Oroxylum indicum bark, on insulin resistance and cog...
Detailed Description
Mild cognitive impairment (MCI) often occurs alongside metabolic disturbances such as insulin resistance and chronic inflammation, which are recognized contributors to neurodegenerative risk. Sabroxy®...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
November 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 25 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT07220694
Start Date
November 27 2025
End Date
December 25 2025
Last Update
November 25 2025
Active Locations (1)
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1
San Francisco Research Institute
San Francisco, California, United States, 94132