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Sabroxy® Supplementation for Insulin Resistance and Cognitive Function in Mild Cognitive Impairment

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Study Aim

This study aims to evaluate whether Sabroxy supplementation can improve insulin resistance and cognitive function in individuals with mild cognitive impairment.

What is being tested

Sabroxy®

+ Placebo

Dietary SupplementOther
Who is being recruted

Mental Disorders+8

+ Cognition Disorders

+ Hyperinsulinism

From 40 to 80 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: January 2026
See protocol details

Summary

Principal SponsorSF Research Institute, Inc.
Study ContactDr. John Ademola
Last updated: January 29, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 29, 2026

Actual date on which the first participant was enrolled.

This study is focused on evaluating how a dietary supplement called Sabroxy® may help people who have mild cognitive impairment (MCI) and insulin resistance. MCI can often occur with conditions like insulin resistance and inflammation, which are known to increase the risk of brain-related diseases. Sabroxy® is derived from the bark of the Oroxylum indicum tree and is traditionally used in Ayurvedic medicine. It has shown promise in previous studies for its potential to support brain health and regulate blood sugar levels. This research is important because it seeks to find a natural way to improve both brain function and blood sugar control in people dealing with these early signs of metabolic and cognitive decline. Participants in the study are randomly assigned to receive either Sabroxy® or a placebo, which is a harmless pill with no active ingredients, once daily for eight weeks. The main goal is to see if Sabroxy® can reduce insulin resistance, a measure of how well the body uses glucose. Additionally, the study checks for improvements in memory and thinking skills using various tests, and looks at changes in certain chemicals in the blood that are linked to brain health and inflammation. The trial takes place at the San Francisco Research Institute and includes safety checks like monitoring side effects and regular health assessments. These measures help ensure the study is conducted safely and provide reliable data on Sabroxy®'s effectiveness.

Official TitleAn 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
NCT07220694
Principal SponsorSF Research Institute, Inc.
Study ContactDr. John Ademola
Last updated: January 29, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

140 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersCognition DisordersHyperinsulinismInsulin ResistanceMetabolic DiseasesNervous System DiseasesNutritional and Metabolic DiseasesNeurodegenerative DiseasesNeurocognitive DisordersGlucose Metabolism DisordersCognitive Dysfunction

Criteria

7 inclusion criteria required to participate
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
Screening HOMA-IR value ≥ 2.0 to < 4.0
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13 exclusion criteria prevent from participating
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.).
Breastfeeding, pregnant, or planning to become pregnant during the study, according to the subject's self-report.
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.
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.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Subjects are to take two capsules with water in the am.

Group II

Placebo
Subjects are to take two capsules with water in the am.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

San Francisco Research Institute

San Francisco, United StatesOpen San Francisco Research Institute in Google Maps
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One Study Center