Originally published on Chain Drug Reviews, October 7, 2024. Answered by Dr. Gary Kay, principal investigator for the original FOCUSfactor clinical study. Download the PDF article here.
Chain Drug Reviews’ Question and Answer Forum
The FOCUSfactor brand has been providing high-quality brain health nutrition for 25 years. FOCUSfactor Original formula was clinically tested by Cognitive Research Corp. and shown to improve memory, concentration and focus.
Q: What are some characteristics of a well-designed clinical study for a supplement?
A: A well-designed clinical study is conducted with the rigor and with the same processes and standards used in clinical drug trials conducted for submission to the Food and Drug Administration. Some of the characteristics of a well-designed study include establishing a randomized, double-blinded, placebo-controlled, fully powered, parallel group study with pre-defined study endpoints and a detailed statistical analysis plan.
Q: What were the key findings of the FOCUSfactor clinical study? And what are the practical implications of your findings for consumers and health care professionals?
A: Based upon standardized, validated neurocognitive testing, using globally accepted measures of memory and other cognitive functions, FOCUSfactor has been clinically shown to improve memory, concentration and focus. The magnitude of the effect of FOCUSfactor might best be expressed in terms of the effects of normal aging on memory. Subjects who received FOCUSfactor in a clinical trial showed an improvement in recall comparable to a 20-year age difference. They performed more like 30-year-olds than like 50-year-olds on memory testing.
Q: What makes the FOCUSfactor clinical study different from other supplement studies?
A: The FOCUSfactor clinical study followed the rigorous processes and standards required for clinical drug submissions. In the FOCUSfactor study and in pharmaceutical trials, the primary endpoint of the study is pre-specified and the database is locked before any analysis or unblinding occurs. Academic studies, which is where most nutraceutical studies are conducted, don’t generally follow these standards and processes. Additionally, the FOCUSfactor study was conducted on the entire 52-ingredient formulation, whereas academic studies typically investigate one or two ingredients.
Q: Can you briefly explain the use of the RAVLT and CogScreen tests in the FOCUSfactor trial?
A: The Rey Auditory Verbal Learning Test (RAVLT) was selected for the FOCUSfactor clinical study because it is one of the most commonly used neuropsychological tests of verbal memory, recognized globally for its exceptionally high reliability and validity. CogScreen is a computer-administered cognitive test battery relied upon by the FAA to evaluate the neurocognitive functioning of pilots and has been used in pharmaceutical studies submitted to the FDA to establish the safety of drugs.
Q: What were the most surprising findings from the study, and how do they compare to previous research in this area?
A: We were surprised by the magnitude of cognitive improvement observed following six weeks of treatment. We had previous experience with some of the individual components of FOCUSfactor, but had not previously investigated the combination of multivitamins and nutritional factors present in FOCUSfactor.
