NCT07220694

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: SF Research Institute, Inc. · Network
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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 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.

Conditions

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

Interventions

Type	Name	Description
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 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.
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) 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.

Timeline

• Start date: 2026-01-29
• Primary completion: 2026-03-28
• Completion: 2026-04-29
• First posted: 2025-10-24
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States