Effects of Sabroxy® Supplementation on Insulin Resistance and Cognitive Function in Adults With Mild Cognitive Impairment and Insulin Resistance

NCT ID: NCT07220694

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-27
• Study Completion Date: 2025-12-25

Brief 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 35-80 years) who are non-smokers, with fasting glucose levels between 100-135 mg/dL 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.

Conditions

Insulin Resistance; Mild Cognitive Impairment; Cognitive Decline; Neurodegenerative Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dietary Supplement (Sabroxy®)

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

Group Type: ACTIVE_COMPARATOR

Sabroxy®

Intervention Type: DIETARY_SUPPLEMENT

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.

Placebo (Inactive capsule)

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Interventions

Sabroxy®

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type: OTHER

Other Intervention Names

Oroxylum indicum bark extract, Sabroxy® 250 mg + BioPerine® 5 mg; Matching Placebo Capsule

Eligibility Criteria

Inclusion Criteria

• Female or male, adults grouped by age as follows :

3 groups of 40 patients each (20 active and 20 placebo)- (age groups - GROUP 1 = aged 35 - 50, GROUP 2 = aged 51-65 and Group 3 = aged 66-80 years.

• In good general health
• Screening fasting glucose 100 to 135 mg/dL
• Screening MoCA less than 26

Exclusion Criteria

• • 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 gastro-intestinal diseases, severe depression, cardiovascular disease occurrence within the last 3 months, etc.),
• Regular intake of medications or supplements known to affect glucose tolerance
• Diabetes of any kind
• Breastfeeding, pregnant, or planning to become pregnant during the study according to subject 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.
• 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. Noninvasive 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 clinical trial involving the test area within 2 weeks before study enrollment 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sabinsa Corporation

INDUSTRY

Sponsor Role: collaborator

SF Research Institute, Inc.

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

San Francisco Research Institute

San Francisco, California, United States

Countries

United States

Other Identifiers

SB20251021- A

Identifier Type: -

Identifier Source: org_study_id