Aims
This study used an open-label design, comprising a one-arm eight-weeks-long study, and aimed to evaluate patient satisfaction and the efficacy of a novel dietary supplement composition combined with probiotic and omega-3 to support brain health improvement in 39 participants with confirmed or suspected brain fog caused by trauma, disease, exposure to chemotherapeutics, or similar events.
Methods
The primary measure was the change from baseline in survey scores of the Montreal Cognitive Assessment. The secondary outcome was the change from baseline in test scores of the self-reported survey.
Results
The results indicated significant improvements across all domains over time (p < 0.0001), with the most substantial changes occurring by Week 8. Repeated-measures analysis of variance showed a significant time effect (F [2.811, 105.4] = 43.09, p < 0.0001), suggesting that cognitive scores progressively improved across the weeks.
Conclusions
This exploratory research indicates that the trial kit was feasible, well tolerated, and associated with improvements in exploratory cognitive measures and perceived well-being over an eight-week period, although practice and placebo effects cannot be ruled out. The findings are hypothesis-generating and support further evaluations in randomized, placebo-controlled studies using well-characterized interventions, objective adherence measures, and biomarker-based outcomes.