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New treatment option for Insulin Resistance
Official title Effects of Sabroxy® Supplementation on Insulin Resistance and Cognitive Function in Adults With Mild Cognitive Impairment and Insulin Resistance
ClinicalTrials.gov ID: NCT07220694
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Having a history of skin cancer within the past 5 years.
See the full eligibility 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
- 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...
- 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 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.