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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

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NIAID Data Ecosystem2026-05-10 收录
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https://figshare.com/articles/dataset/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/31986754
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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. 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. 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. 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. Some people experience what is often described as “brain fog,” which may include forgetfulness, difficulty concentrating, mental fatigue, and reduced clarity of thinking. These symptoms can occur after illness, injury, chemotherapy, or chronic health conditions. Although many individuals seek nutritional approaches to improve these symptoms, scientific evidence remains limited. This study explored whether a combination of dietary supplements (a multi-ingredient formula, probiotics, and omega-3 fatty acids) was associated with changes in self-reported cognitive symptoms over an 8-week period. Thirty-nine adults who reported symptoms consistent with brain fog participated in the study. All participants received the supplement combination, and there was no comparison or placebo group. Over the 8 weeks, participants showed improvements in cognitive screening scores and reported feeling better in areas such as focus, memory, and energy. However, because the study did not include a placebo group and participants knew they were taking supplements, it is not possible to determine whether the improvements were caused by the supplements. Repeated testing may also have contributed to better scores over time. The supplements were generally well tolerated, and most participants completed the study. These findings suggest that further research may be worthwhile. Larger, well-designed studies that include comparison groups are needed to determine whether this supplement combination is truly effective for individuals experiencing symptoms often described as brain fog. This study evaluated an 8-week, open-label, single-arm intervention in adults reporting symptoms consistent with “brain fog,” including reduced concentration, memory difficulties, and mental fatigue. Participants received a multi-component dietary supplementation approach consisting of a novel dietary supplement formulation combined with probiotics and omega-3 fatty acids. Cognitive performance was assessed using repeated Montreal Cognitive Assessment (MOCA) testing, alongside investigator-developed self-reported measures of concentration, recall, focus, energy level, and overall brain health. Statistically significant improvements over time were observed in both exploratory cognitive screening scores and self-reported well-being measures. The intervention was generally well tolerated, and study completion rates were high (39 of 40 participants completed the 8-week period). Due to the absence of a placebo-controlled comparison group, improvements cannot be definitively attributed to the intervention. Natural symptom fluctuation, regression to the mean, expectancy effects, and practice effects related to repeated testing may have contributed to the observed changes. The findings should be considered exploratory and hypothesis-generating rather than confirmatory evidence of efficacy. Larger, randomized, placebo-controlled studies with well-characterized formulations, objective adherence monitoring, validated outcome measures, and biomarker-based endpoints are needed to establish efficacy and clarify underlying mechanisms. This study evaluated an 8-week, open-label, single-arm intervention in adults reporting symptoms consistent with “brain fog,” including reduced concentration, memory difficulties, and mental fatigue. Participants received a multi-component dietary supplementation approach consisting of a novel dietary supplement formulation combined with probiotics and omega-3 fatty acids. Cognitive performance was assessed using repeated Montreal Cognitive Assessment (MOCA) testing, alongside investigator-developed self-reported measures of concentration, recall, focus, energy level, and overall brain health. Statistically significant improvements over time were observed in both exploratory cognitive screening scores and self-reported well-being measures. The intervention was generally well tolerated, and study completion rates were high (39 of 40 participants completed the 8-week period). Due to the absence of a placebo-controlled comparison group, improvements cannot be definitively attributed to the intervention. Natural symptom fluctuation, regression to the mean, expectancy effects, and practice effects related to repeated testing may have contributed to the observed changes. The findings should be considered exploratory and hypothesis-generating rather than confirmatory evidence of efficacy. Larger, randomized, placebo-controlled studies with well-characterized formulations, objective adherence monitoring, validated outcome measures, and biomarker-based endpoints are needed to establish efficacy and clarify underlying mechanisms.
创建时间:
2026-04-11
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