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NCT07220694 · ClinicalTrials.gov registry record · NA
Effects of Sabroxy® Supplementation on Insulin Resistance and Cognitive Function in Adults With Mild Cognitive Impairment and Insulin Resistance
A NA study of Mild Cognitive Impairment and Insulin Resistance, sponsored by SF Research Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT07220694 is a NA study of Mild Cognitive Impairment and Insulin Resistance that is actively recruiting participants, run by SF Research Institute. The registered enrollment target is 140 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07220694, a NA study of Mild Cognitive Impairment and Insulin Resistance, is actively recruiting participants, sponsored by SF Research Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study 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 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 Studied
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Sabroxy®
Study Locations (1)
California
- San Francisco Research Institute - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2026-01-29 |
| Est. Completion | 2026-04-29 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07220694
The ClinicalTrials.gov registry entry for NCT07220694 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (89% lower). The listed sponsor is SF Research Institute, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07220694 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT07220694 about?
NCT07220694 is a clinical study titled "Effects of Sabroxy® Supplementation on Insulin Resistance and Cognitive Function in Adults With Mild Cognitive Impairment and Insulin Resistance". 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 par...
What is the current status of trial NCT07220694?
This trial is currently recruiting. It is a NA study. The enrollment target is 140 participants. The study started on 2026-01-29. Estimated completion is 2026-04-29.
What conditions does trial NCT07220694 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Insulin Resistance, Cognitive Decline, Neurodegenerative Disorders.
What interventions are being tested in trial NCT07220694?
The interventions under investigation include: Placebo (OTHER), Sabroxy® (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07220694?
This trial is sponsored by SF Research Institute, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07220694 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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