Evaluation of a multi-component dietary supplement combined with probiotic and omega-3 in individuals with self-reported symptoms of brain fog: an 8-week exploratory study
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.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 39 participants or records.
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