Effects of Sabroxy® Supplementation on Insulin Resistance and Cognitive Function in Adults With Mild Cognitive Impairment and Insulin Resistance: A Randomized, Double-Blind, Placebo-Controlled Study

Not Applicable

Not yet recruiting

• Conditions: Insulin Resistance; Mild Cognitive Impairment; Metabolic Dysfunction; Cognitive Decline; Neurodegenerative Disorders

• Registration Number: NCT07220694
• Lead Sponsor: SF Research Institute, Inc.

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

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-22
• Study First Submitted QC: 2025-10-22
• Last Update Submitted: 2025-10-22
• Study First Posted: 2025-10-24
• Last Update Posted: 2025-10-24
• Study Start: 2025-11-17
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Insulin Resistance as Assessed by HOMA-IR	Baseline 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.

Secondary Outcome Measures

Name	Time	Method
Change in Cognitive Function Scores (Immediate Word Recall Test)	Baseline and Week 8	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.
Change in Serum Brain-Derived Neurotrophic Factor (BDNF)	Baseline and Week 8	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.
Change in Working Memory Performance (Numeric Working Memory Test)	Baseline and Week 8	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.
Change in Self-Perceived Cognitive Failures (Cognitive Failures Questionnaire-CFQ)	Baseline and Week 8	Participants' self-reported everyday cognitive lapses will be evaluated using the Cognitive Failures Questionnaire (CFQ). The change in CFQ score from baseline to Week 8 will indicate improvement in cognitive function.
Change in Inflammatory Biomarker (High-Sensitivity C-Reactive Protein, hs-CRP)	Baseline and Week 8	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.
Change in Oxidative Stress Biomarkers (MDA, SOD, GPx)	Baseline and Week 8	Oxidative stress and antioxidant enzyme activity will be measured using malondialdehyde (MDA), superoxide dismutase (SOD), and glutathione peroxidase (GPx) assays.
Change in Serum Phosphorylated Tau/Amyloid Beta Ratio (p-Tau/Aβ)	Baseline and Week 8	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.
Change in Montreal Cognitive Assessment (MoCA) Total Score	Baseline and Week 8	Global cognitive function will be measured using the MoCA. Change in total score from baseline to Week 8 will be analyzed to assess overall cognitive improvement.

Trial Locations

Locations (1)

San Francisco Research Institute; 🇺🇸 San Francisco, California, United States