A Randomized Double-Blind Placebo-Controlled Trial of a Purported Dietary Supplement Cognitive Enhancer in Healthy Teenage Subjects

Introduction: The prevalence of using dietary supplements among teenagers is rising. In particular, the use of nutritional supplements to improve cognitive performance is becoming more commonplace. Given the prevalence of use, it is important to empirically assess the effects of nutritional supplements on cognitive performance. The current study sought to test the effects of an existing cognition supplement, Brain Doctors’ Formula® (BDF) Mega Brain Boost® (MBB), across different cognitive domains in a healthy teenage population. Methods: We carried out a 6-week randomized, placebo-controlled, double-blind study. The study lasted approximately 42 days (6 weeks) for each participant. Study visits included screening and baseline testing, week 3 interim and week 6 end of study visit. Cognition outcomes were measured by the National Institutes of Health (NIH) Toolbox Cognitive Battery of Testing (Dimensional Change, Flanker, and Pattern Comparison) and a Symmetry Span Task at baseline, interim, and final visits. Another efficacy outcome was the self-assessment of mind wandering, which was captured in a study daily diary from baseline to the end of study visit. There were two study groups, including one MBB group and one placebo group. Twenty-four participants were screened and randomized to include 12 participants in each group. Results: The change from baseline to interim (Week 3) and from baseline to the final visit (Week 6) did not show a significant between-group difference on any measure of cognition (all p-values >0.05) except one. There was a significant between-group difference with a large effect size at Week 3 showing that the MBB group performed significantly better than the placebo group on the Dimensional Change Card Sort Task. Conclusions: This study suggests that MBB potentially improves executive cognitive processes (as assessed by the Dimensional Change Card Sort Task) in healthy teenagers. However, this effect was only significant at the interim visit. Therefore, it is uncertain if there are any lasting beneficial effects. Further research should be conducted in a larger group of participants and focus on broader measures of executive function.