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

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

Overview

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.

Interventions

• Dietary supplement 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 Corpora
• Other 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) condit

Primary outcome measures

• Change in Insulin Resistance as Assessed by HOMA-IR [Time frame: Prescreening -14 days and Week 8]

Secondary outcome measures (10)

• 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]

Eligibility criteria

Inclusion criteria

• 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

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 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• San Francisco Research Institute — San Francisco

Identifiers

NCT: NCT07220694 · SB20251021- A

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗