Sabroxy® for lowering insulin resistance and improving memory in adults with mild cognitive impairment

An 8-week Study Evaluating the Effects of a Dietary Supplement (Sabroxy®) on Insulin Resistance and Cognitive Function in Subjects With Mild Cognitive Impairment and Insulin Resistance

This 8-week, double-blind, placebo-controlled test will see if taking Sabroxy® once daily lowers insulin resistance and improves thinking and memory in adults aged 40–80 with mild cognitive impairment and elevated fasting glucose or HOMA-IR.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: SF Research Institute, Inc. (network)
• Drugs / interventions: belimumab, chemotherapy, radiation, methotrexate, cyclophosphamide, prednisone
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT07220694 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled trial will enroll 120 non-smoking adults (age 40–80) with mild cognitive impairment (MoCA < 26) and insulin resistance (fasting glucose 100–135 mg/dL, HOMA-IR ≥ 2.0 to < 4.0). Participants are randomized 1:1 to receive Sabroxy® (250 mg with 5 mg BioPerine®) or matching placebo once daily for 8 weeks. The primary outcome is change in insulin resistance measured by HOMA-IR from baseline to Week 8, with secondary outcomes including tests of memory and working memory, MoCA, inflammatory and neuronal biomarkers (hs-CRP, BDNF, p-Tau/Aβ ratio), and safety monitoring. All procedures are conducted at the San Francisco Research Institute under standard ethical and regulatory guidelines.

Who should consider this trial

Good fit: Adults aged 40–80 who are non-smokers, in generally good health, have MoCA < 26, fasting glucose 100–135 mg/dL and a HOMA-IR between 2.0 and <4.0, and who are not taking medications or supplements that affect glucose tolerance are ideal candidates.

Not a fit: People with normal glucose regulation or HOMA-IR outside the specified range, those taking glucose-altering medications or supplements, pregnant or breastfeeding individuals, or those with significant unstable medical conditions are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, Sabroxy® could provide a well-tolerated oral supplement that reduces insulin resistance and may modestly improve cognitive performance in adults with MCI and metabolic dysregulation.

How similar studies have performed: Preclinical studies of Oroxylum indicum extracts show antioxidant, neuroprotective, and glucose-regulatory effects, but clinical evidence for Sabroxy® in humans with MCI and insulin resistance is limited and this application is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Female or male, adults grouped by age as follows 2 groups of 70 patients each (35 active and 35 placebo )

   * GROUP 1 = aged 40 - 60, and
   * GROUP 2 = aged 61 - 80
2. In good general health
3. Screening HOMA-IR value ≥ 2.0 to \< 4.0
4. Screening fasting glucose 100 to 135 mg/dL
5. Screening MoCA less than 26

Exclusion Criteria:

1. Having been diagnosed with known allergies to any ingredients in the study product.
2. Relevant history or presence of any medical disorder potentially interfering with this study (e.g., malabsorption, chronic gastrointestinal diseases, severe depression, cardiovascular disease occurrence within the last 3 months, etc.),
3. Regular intake of medications or supplements known to affect glucose tolerance
4. Breastfeeding, pregnant, or planning to become pregnant during the study, according to the subject's self-report.
5. 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.
6. Having a history of skin cancer within the past 5 years.
7. 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.
8. 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).
9. 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.
10. Having started a long-term medication within the last 2 months.
11. Having planned surgeries or invasive medical procedures during the study. Non-invasive medical procedures or surgeries will be reviewed for their impact on the study outcome and acceptability by the Investigator or designee.
12. Currently participating in any other clinical trial at SFRI or another research facility or doctor's office.
13. Having participated in any other clinical trial that evaluates or applies interventions to the same body system, organ, or condition being studied in this trial within 12 weeks prior to the screening visit at SFRI or another research facility or doctor's office.
14. 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.

Where this trial is running

San Francisco, California

• San Francisco Research Institute — San Francisco, California, United States (RECRUITING)

Study contacts

• Study coordinator: Dr. John Ademola

Conditions: Insulin Resistance, Mild Cognitive Impairment, Cognitive Decline, Neurodegenerative Disorders, BioPerine, Insulin Sensitivity, Cognitive Function, Memory Performance