Insulin ResistanceNCT07220694
Effects of Sabroxy® Supplementation on Insulin Resistance and Cognitive Function in Adults With Mild Cognitive Impairment and Insulin Resistance
A study testing Sabroxy® in people with Insulin Resistance and Mild Cognitive Impairment, run by SF Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Mild Cognitive Impairment, Cognitive Decline
- What is being tested?
- Sabroxy®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2026to 29 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- In good general health
- Screening HOMA-IR value ≥ 2.0 to < 4.0
- Screening fasting glucose 100 to 135 mg/dL
- Screening MoCA less than 26
Who cannot join
- Having been diagnosed with known allergies to any ingredients in the study product.
- 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.),
- Regular intake of medications or supplements known to affect glucose tolerance
- Breastfeeding, pregnant, or planning to become pregnant during the study, according to the subject's self-report.
- 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.
- Having a history of skin cancer within the past 5 years.
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- 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).
- 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.
- Having started a long-term medication within the last 2 months.
- 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.
- Currently participating in any other clinical trial at SFRI or another research facility or doctor's office.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Francisco Research Institute
San Francisco, California, 94132
Khaleeq Rehman, 415-690-9641, khaleeqr.sfinstitute@gmail.com
About this study
Official title: 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 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.
Read more
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.
Read the detailed description
Mild cognitive impairment (MCI) often occurs alongside metabolic disturbances such as insulin resistance and chronic inflammation, which are recognized contributors to neurodegenerative risk. Sabroxy® is a standardized extract of Oroxylum indicum bark, traditionally used in Ayurvedic medicine, and has demonstrated antioxidant, neuroprotective, and glucose-regulatory properties in preclinical studies.
This study aims to evaluate the potential of Sabroxy® supplementation to improve both metabolic and cognitive outcomes in adults with MCI and insulin resistance. The trial follows a randomized, double-blind, placebo-controlled design, with 120 eligible participants randomized in a 1:1 ratio to receive either Sabroxy® (250 mg combined with 5 mg BioPerine®) or placebo once daily for 8 weeks.
The primary objective is to assess the effect of Sabroxy® on insulin resistance as measured by HOMA-IR. Secondary objectives include assessing cognitive function improvements (using Immediate Word Recall, Numeric Working Memory, CFQ, and MoCA tests), as well as evaluating changes in biochemical markers related to neuronal health (BDNF, p-Tau/Aβ ratio) and inflammation (hs-CRP).
Safety assessments include adverse event monitoring, vital signs, and standard clinical laboratory evaluations throughout the study. All study procedures are conducted at the San Francisco Research Institute (USA) in accordance with the Declaration of Helsinki, ICH-GCP guidelines, and 21 CFR Part 312 (where applicable).
The outcomes from this study are expected to contribute evidence on the dual role of Sabroxy® in improving glucose tolerance and supporting cognitive function in individuals exhibiting early metabolic and neurocognitive dysfunctions.
- Conditions
- Insulin Resistance, Mild Cognitive Impairment, Cognitive Decline, Neurodegenerative Disorders
- Being tested
- Sabroxy®, Placebo
- Keywords
- BioPerine, Insulin Sensitivity, Cognitive Function, Memory Performance, Sabroxy
- Medical subject headings
- Insulin Resistance, Cognitive Dysfunction, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sabroxy®Dietary supplement
Also called Oroxylum indicum bark extract, Sabroxy® 250 mg + BioPerine® 5 mg
Sabroxy® is a standardized extract of Oroxylum indicum bark formulated with BioPerine® (black pepper extract) to enhance bioavailability. Each capsule contains 250 mg of Sabroxy® and 5 mg of BioPerine®, administered once daily after breakfast with water for 8 weeks.
Sabroxy® is standardized for bioactive flavonoids such as oroxylin A, baicalein, and chrysin, which are known for their antioxidant, neuroprotective, and anti-inflammatory properties.
The product will be supplied by Sabinsa Corporation (East Windsor, NJ, USA) under Good Manufacturing Practice (GMP) conditions and will be packaged in identical capsules to maintain blinding.
The intervention aims to evaluate the effects of Sabroxy® on insulin resistance, inflammation, and cognitive performance in adults with mild cognitive impairment and insulin resistance.
PlaceboOther
Also called Matching Placebo Capsule
The placebo consists of identical capsules containing inert excipients (microcrystalline cellulose and magnesium stearate) with no active botanical ingredients.
The capsules are identical in appearance, weight, color, and packaging to the Sabroxy® capsules to maintain blinding.
Participants assigned to the placebo group will receive one capsule orally once daily after breakfast with water for 8 weeks.
The placebo will be manufactured and supplied under Good Manufacturing Practice (GMP) conditions by Sabinsa Corporation (East Windsor, NJ, USA).
This control group will enable comparison of Sabroxy®'s efficacy and safety against a non-active formulation to validate clinical outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement (Sabroxy®) | Active comparator | Subjects are to take two capsules with water in the am. Receives: Dietary Supplement: Sabroxy® |
| Placebo (Inactive capsule) | Placebo comparator | Subjects are to take two capsules with water in the am. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin Resistance as Assessed by HOMA-IR
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.
Measured: Prescreening -14 days and Week 8
Secondary outcomes (10)
Change in Cognitive Function Scores (Immediate Word Recall Test)
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.
Measured: Baseline- Day 1 and Week 8
Change in Working Memory Performance (Numeric Working Memory Test)
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.
Measured: Baseline- Day 1 and Week 8
Change in Self-Perceived Cognitive Failures (Cognitive Failures Questionnaire-CFQ)
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.
Measured: Baseline- Day 1 and Week 8
Change in Montreal Cognitive Assessment (MoCA) Total Score
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.
Measured: Prescreening -14 days and Week 8
Change in Serum Brain-Derived Neurotrophic Factor (BDNF)
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.
Measured: Prescreening -14 days and Week 8
Change in Inflammatory Biomarker (High-Sensitivity C-Reactive Protein, hs-CRP)
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.
Measured: Prescreening -14 days and Week 8
Change in Oxidative Stress Biomarkers- Malondialdehyde (MDA) Concentration
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.
Measured: Prescreening -14 days and Week 8
Change in Serum Phosphorylated Tau/Amyloid Beta Ratio (p-Tau/Aβ)
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.
Measured: Prescreening -14 days and Week 8
Change in Superoxide Dismutase (SOD) Activity
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.
Measured: Prescreening -14 days and Week 8
Change in Glutathione Peroxidase (GPx) Activity
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.
Measured: Prescreening -14 days and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start29 Jan 2026 (estimated)
- Primary completion28 Mar 2026 (estimated)
- Study completion29 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SF Research Institute, Inc.
- Sponsor type
- Research network
- Collaborators
- Sabinsa Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220694
- Sponsor's protocol ID
- SB20251021- A
- Status last verified
- Jan 2026
- First submitted
- 22 Oct 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07220694
- Acronym / sponsor ID
- SB20251021- A
- Conditions
- Insulin Resistance, Mild Cognitive Impairment, Cognitive Decline, Neurodegenerative Disorders
- Keywords
- BioPerine, Insulin Sensitivity, Cognitive Function, Memory Performance, Sabroxy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- SF Research Institute, Inc.Research network
- Collaborators
- Sabinsa Corporation
- Study start
- 29 Jan 2026 (estimated)
- Primary completion
- 28 Mar 2026 (estimated)
- Study completion
- 29 Apr 2026 (estimated)
- First posted
- 24 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mild cognitive impairment (MCI) often occurs alongside metabolic disturbances such as insulin resistance and chronic inflammation, which are recognized contributors to neurodegenerative risk. Sabroxy® is a standardized extract of Oroxylum indicum bark, traditionally used in Ayurvedic medicine, and has demonstrated antioxidant, neuroprotective, and glucose-regulatory properties in preclinical studies.
This study aims to evaluate the potential of Sabroxy® supplementation to improve both metabolic and cognitive outcomes in adults with MCI and insulin resistance. The trial follows a randomized, double-blind, placebo-controlled design, with 120 eligible participants randomized in a 1:1 ratio to receive either Sabroxy® (250 mg combined with 5 mg BioPerine®) or placebo once daily for 8 weeks.
The primary objective is to assess the effect of Sabroxy® on insulin resistance as measured by HOMA-IR. Secondary objectives include assessing cognitive function improvements (using Immediate Word Recall, Numeric Working Memory, CFQ, and MoCA tests), as well as evaluating changes in biochemical markers related to neuronal health (BDNF, p-Tau/Aβ ratio) and inflammation (hs-CRP).
Safety assessments include adverse event monitoring, vital signs, and standard clinical laboratory evaluations throughout the study. All study procedures are conducted at the San Francisco Research Institute (USA) in accordance with the Declaration of Helsinki, ICH-GCP guidelines, and 21 CFR Part 312 (where applicable).
The outcomes from this study are expected to contribute evidence on the dual role of Sabroxy® in improving glucose tolerance and supporting cognitive function in individuals exhibiting early metabolic and neurocognitive dysfunctions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement (Sabroxy®) | Active comparator | Dietary Supplement: Sabroxy®Subjects are to take two capsules with water in the am. |
| Placebo (Inactive capsule) | Placebo comparator | Other: PlaceboSubjects are to take two capsules with water in the am. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female or male, adults grouped by age as follows 2 groups of 70 patients each (35 active and 35 placebo )
- In good general health
- Screening HOMA-IR value ≥ 2.0 to < 4.0
- Screening fasting glucose 100 to 135 mg/dL
- Screening MoCA less than 26
Key exclusion criteria (14 listed)
- Having been diagnosed with known allergies to any ingredients in the study product.
- 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.),
- Regular intake of medications or supplements known to affect glucose tolerance
- Breastfeeding, pregnant, or planning to become pregnant during the study, according to the subject's self-report.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sabroxy®Also: Oroxylum indicum bark extract, Sabroxy® 250 mg + BioPerine® 5 mgSabroxy® is a standardized extract of Oroxylum indicum bark formulated with BioPerine® (black pepper extract) to enhance bioavailability. Each capsule contains 250 mg of Sabroxy® and 5 mg of BioPerine®, administered once daily after breakfast with water for 8 weeks. Sabroxy® is standardized for bioactive flavonoids such as oroxylin A, baicalein, and chrysin, which are known for their antioxidant, neuroprotective, and anti-inflammatory properties. The product will be supplied by Sabinsa Corporation (East Windsor, NJ, USA) under Good Manufacturing Practice (GMP) conditions and will be packaged in identical capsules to maintain blinding. The intervention aims to evaluate the effects of Sabroxy® on insulin resistance, inflammation, and cognitive performance in adults with mild cognitive impairment and insulin resistance. | Dietary supplement | Dietary Supplement (Sabroxy®) |
| PlaceboAlso: Matching Placebo CapsuleThe placebo consists of identical capsules containing inert excipients (microcrystalline cellulose and magnesium stearate) with no active botanical ingredients. The capsules are identical in appearance, weight, color, and packaging to the Sabroxy® capsules to maintain blinding. Participants assigned to the placebo group will receive one capsule orally once daily after breakfast with water for 8 weeks. The placebo will be manufactured and supplied under Good Manufacturing Practice (GMP) conditions by Sabinsa Corporation (East Windsor, NJ, USA). This control group will enable comparison of Sabroxy®'s efficacy and safety against a non-active formulation to validate clinical outcomes. | Other | Placebo (Inactive capsule) |
Primary outcome
Change in Insulin Resistance as Assessed by HOMA-IR
Time frame: Prescreening -14 days and Week 8
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.
10 secondary outcomes
Change in Cognitive Function Scores (Immediate Word Recall Test)
Time frame: Baseline- Day 1 and Week 8
Change in Working Memory Performance (Numeric Working Memory Test)
Time frame: Baseline- Day 1 and Week 8
Change in Self-Perceived Cognitive Failures (Cognitive Failures Questionnaire-CFQ)
Time frame: Baseline- Day 1 and Week 8
Change in Montreal Cognitive Assessment (MoCA) Total Score
Time frame: Prescreening -14 days and Week 8
Change in Serum Brain-Derived Neurotrophic Factor (BDNF)
Time frame: Prescreening -14 days and Week 8
Change in Inflammatory Biomarker (High-Sensitivity C-Reactive Protein, hs-CRP)
Time frame: Prescreening -14 days and Week 8
Change in Oxidative Stress Biomarkers- Malondialdehyde (MDA) Concentration
Time frame: Prescreening -14 days and Week 8
Change in Serum Phosphorylated Tau/Amyloid Beta Ratio (p-Tau/Aβ)
Time frame: Prescreening -14 days and Week 8
Change in Superoxide Dismutase (SOD) Activity
Time frame: Prescreening -14 days and Week 8
Change in Glutathione Peroxidase (GPx) Activity
Time frame: Prescreening -14 days and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sabroxy® in people with Insulin Resistance and Mild Cognitive Impairment, run by SF Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. John Ademola (415-845-4638, jademola@sfinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insulin Resistance as Assessed by HOMA-IR (time frame: Prescreening -14 days and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.