Actively Recruiting
Effects of Sabroxy® Supplementation on Insulin Resistance and Cognitive Function in Adults With Mild Cognitive Impairment and Insulin Resistance
Led by SF Research Institute, Inc. · Updated on 2026-01-28
140
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
S
SF Research Institute, Inc.
Lead Sponsor
S
Sabinsa Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 cognitive function in adults with mild cognitive impairment and insulin resistance. A total of 120 participants (men and women, aged 40-80 years) who are non-smokers, with fasting glucose levels between 100-135 mg/dL, HOMA-IR value ≥ 2.0 to \< 4.0, and a Montreal Cognitive Assessment (MoCA) score below 26, will be enrolled. Eligible participants will be randomized (1:1) to receive either Sabroxy® (250 mg with 5 mg BioPerine®) or placebo, administered orally once daily for 8 weeks. The primary endpoint is the change in insulin resistance from baseline to Week 8, assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). The secondary endpoints include changes in: Cognitive performance, assessed using the Immediate Word Recall, Numeric Working Memory, Cognitive Failures Questionnaire (CFQ), and Montreal Cognitive Assessment (MoCA). Biomarkers of metabolic and neuronal function, including Brain-Derived Neurotrophic Factor (BDNF), high-sensitivity C-reactive protein (hs-CRP), fasting insulin, fasting glucose, and phosphorylated tau/amyloid beta (p-Tau/Aβ) ratio. Safety will be assessed through adverse event monitoring, vital signs, and routine clinical laboratory tests. The study will be conducted at a single site, San Francisco Research Institute (USA), in compliance with the Declaration of Helsinki, ICH-GCP guidelines, and 21 CFR Part 312 (where applicable). This study seeks to generate clinical evidence supporting the potential of Sabroxy® supplementation to improve glucose tolerance, reduce inflammation, and enhance cognitive function in individuals with early metabolic and neurocognitive dysfunctions.
CONDITIONS
Official Title
Effects of Sabroxy® Supplementation on Insulin Resistance and Cognitive Function in Adults With Mild Cognitive Impairment and Insulin Resistance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 40 to 80 years, divided into two age groups: 40-60 and 61-80
- In good general health
- Screening HOMA-IR value between 2.0 and less than 4.0
- Screening fasting glucose between 100 and 135 mg/dL
- Montreal Cognitive Assessment (MoCA) score below 26
You will not qualify if you...
- Known allergies to any ingredients in the study product
- Medical disorders that may interfere with the study, such as malabsorption, chronic gastrointestinal diseases, severe depression, or recent cardiovascular events within 3 months
- Regular use of medications or supplements affecting glucose tolerance
- Breastfeeding, pregnant, or planning pregnancy during the study
- Having a pregnant partner or partner planning pregnancy or unwilling/unable to use contraception
- History of skin cancer within the past 5 years
- History of immunosuppression or immune deficiency disorders, organ transplant, or use of immunosuppressive medications or chemotherapy
- Use of systemic or topical corticosteroids within the past 4 weeks
- Uncontrolled conditions such as asthma, diabetes, epilepsy, hypertension, or thyroid disorders
- Starting a long-term medication within the last 2 months
- Planned surgeries or invasive medical procedures during the study
- Participation in another clinical trial at the same or other research facilities
- Participation in a clinical trial involving the same body system within 12 weeks prior to screening
- Medications for chronic diseases that do not affect study product metabolism may be allowed upon investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
San Francisco Research Institute
San Francisco, California, United States, 94132
Actively Recruiting
Research Team
D
Dr. John Ademola
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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