Abstract
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.