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

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Study AimThis 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 Supplement
Other
Who is being recruted

Insulin Resistance
+1

+ Mild Cognitive Impairment
+ Cognitive Decline
From 35 to 80 Years
+22 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: November 2025

See protocol details

Summary

Principal SponsorSF Research Institute, Inc.
Study ContactDr. John Ademola
Last updated: October 28, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 17, 2025Actual 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 
Principal SponsorSF Research Institute, Inc.
Study ContactDr. John Ademola
Last updated: October 28, 2025
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
120 patients to be enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 35 to 80 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Insulin Resistance
Mild Cognitive Impairment
Cognitive Decline
Neurodegenerative Disorders
Criteria
8 inclusion criteria required to participate
GROUP 1 = aged 35 - 50
Group 3 = aged 66-80 years
GROUP 2 = aged 51-65
Female or male, adults grouped by age as follows :

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14 exclusion criteria prevent from participating
Breastfeeding, pregnant, or planning to become pregnant during the study according to subject self-report.
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).

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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
Study Objectives
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 Objectives
Primary Objectives

Insulin resistance will be evaluated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting glucose and fasting insulin levels. The objective is to determine the mean change in HOMA-IR from baseline to Week 8 between the Sabroxy® and placebo groups.
Secondary Objectives

Cognitive performance will be assessed using the Immediate Word Recall test to evaluate short-term memory and verbal learning. The mean change in recall score from baseline to Week 8 will be compared between groups.

Numeric Working Memory test will assess attention, working memory capacity, and processing speed. The change in mean score from baseline to Week 8 will be evaluated between Sabroxy® and placebo groups.

Participants' self-reported everyday cognitive lapses will be evaluated using the Cognitive Failures Questionnaire (CFQ), a 25-item self-assessment scale that measures the frequency of attention, perception, memory, and action failures in daily life. Each item is scored on a 5-point Likert scale (0 = never, 4 = very often), yielding a total score range of 0 to 100, with higher scores indicating greater perceived cognitive failures (worse performance). The change in CFQ total score from baseline to Week 8 will be analyzed to assess improvement in self-perceived cognitive function.

Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a 30-point screening tool designed to detect mild cognitive impairment. The total score ranges from 0 to 30, with higher scores indicating better global cognitive performance. The change in MoCA total score from baseline to Week 8 will be analyzed to evaluate overall cognitive improvement following intervention.

Serum BDNF levels will be quantified to assess neuroplasticity response. Mean change in BDNF concentration from baseline to Week 8 will be compared between study groups.

Systemic inflammation will be assessed through serum hs-CRP concentration. Mean change from baseline to Week 8 will be compared between Sabroxy® and placebo groups.

Oxidative stress will be assessed by measuring malondialdehyde (MDA) levels in serum using a validated spectrophotometric assay. MDA is a biomarker of lipid peroxidation, and its concentration will be expressed in micromoles per liter (µmol/L). The change in MDA concentration from baseline to Week 8 will be analyzed to evaluate the effect of Sabroxy® supplementation on oxidative stress.

The ratio of phosphorylated tau to amyloid beta will be evaluated as a neurodegeneration-related biomarker. Mean change from baseline to Week 8 will be compared between groups.

Antioxidant enzyme activity will be evaluated by measuring superoxide dismutase (SOD) activity in serum using a validated spectrophotometric method. SOD activity will be expressed in units per milliliter (U/mL), where higher activity indicates greater antioxidant defense. The change in SOD activity from baseline to Week 8 will be analyzed to assess improvements in antioxidant status.

Antioxidant defense will also be evaluated through glutathione peroxidase (GPx) enzyme activity in serum, measured via a validated spectrophotometric assay. GPx activity will be expressed in units per milliliter (U/mL), with higher values indicating stronger antioxidant protection. The change in GPx activity from baseline to Week 8 will be analyzed to determine the impact of Sabroxy® on enzymatic antioxidant function.

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
Suspended
San Francisco Research InstituteSan Francisco, United StatesSee the location
Recruiting soonOne Study Center