Abstract
BACKGROUND: Functional dyspepsia (FD) is a prevalent gut-brain interaction disorder that adversely affects cognitive function. Current treatment options offer limited efficacy and are often associated with undesirable side effects. Hence, in this study, we evaluated the efficacy of a food-grade, self-emulsifying hydrogel formulation of Ferula asafoetida oleo-gum resin (ASF) in improving dyspepsia symptoms, cognitive function, sleep quality, and gut microbiota in individuals with FD symptoms. METHODS: A randomized, double-blind, placebo-controlled trial was conducted with 62 participants diagnosed with FD symptoms. Subjects received 250 mg/d of ASF or placebo for 14 days. Outcome measures included the Leuven Postprandial Distress Scale, choice reaction time test, Bergen Insomnia Scale (BIS), Bristol Stool Form Scale, and gut microbiome profiling. RESULTS: ASF treatment showed a significant time, treatment, and treatment × time effect for early satiety, bloating, and heart burn (P < .05). Further analysis of Leuven Postprandial Distress Scale data by Mann-Whitney U test provided the influence of ASF on days 1, 3, 7, and 14 which indicated a progressive improvement in the number of positive responders, especially for bloating, early satiety, and postprandial fullness (P < .05). ASF also significantly modulated the gut microbiota by decreasing the Firmicutes-to-Bacteroidetes ratio (71.9%; P < .001), enhancing alpha diversity (P < .05), enriching beneficial genera (e.g., Bacteroides, Prevotella), and reducing harmful taxa (e.g., Escherichia, Clostridia). Further, ASF demonstrated improvements in digestion and reduced constipation as indicated by the Bristol Stool Form Scale, with type 1 stools decreasing from 65% to 18% and type 2 from 35% to 7% by day 14. Neurocognitive assessments showed improved attention and focus (44% reduction in reaction time, P < .001), while BIS results indicated better sleep quality (ΔBIS = 10.89 ± 3.23, P < .001) on day 14. CONCLUSION: ASF demonstrated significant modulation of the microbiome-gut-brain axis, resulting in reduced dyspepsia symptom severity, enhanced cognitive performance, improved sleep quality, and better digestive outcomes. These findings support the potential of ASF as a safe and effective dietary supplement for gut and cognitive health in individuals with FD.