Feasibility and tolerability of Musa sp. pseudo-stem core powder as a dietary supplement with gut microbiota-modulating potential: a pilot randomised controlled trial.

backgroundThe gut microbiota is increasingly recognised as a therapeutic target for mental disorders, with nutritional supplements providing a direct approach to modulating the gut microbiota. However, existing evidence largely focuses on single nutrients or phytochemicals, highlighting the need for novel multi-component interventions. This pilot study evaluated the feasibility and tolerability of a dietary supplement powder derived from Musa sp. pseudo-stem core that contains a combination of microbiota-modulating nutrients and phytochemicals.

methodsWe recruited 30 healthy adults, aged between 18 and 65 years, from the community to a triple-blinded, 4-week randomised placebo-controlled pilot trial. Participants were randomised to receive either 10 g/day of the Musa sp. pseudo-stem core powder or maltodextrin placebo. Supplement feasibility was defined as consuming at least 80% of the allocated supplement along with habitual diet. Tolerability was defined as no changes in gastrointestinal (GI) symptoms and stool consistency compared with placebo. Exploratory outcomes included psychological symptoms, quality of life, urinary hippurate measured using nuclear magnetic resonance spectroscopy, and stool gut microbiota profiling using 16S rRNA sequencing.

resultsAt the end of the study, 86% of the participants in the supplement group met the 80% consumption threshold, demonstrating intervention feasibility. There were no observed differences in the changes in GI symptoms or stool consistency between the supplement and placebo groups over the period of the study, indicating supplement tolerability. There were no observed differences in the changes in psychological symptoms, quality of life, and urine hippurate levels between groups at week 4. The weighted UniFrac distance showed a structural difference of the gut microbiota community between the supplement and placebo groups at week 4, although no observed differences were found in alpha diversity. Differences in the changes of two bacterial taxa each belonging to the family Anaerovoracaceae and Prevotellaceae were observed in the supplement group compared with the placebo group at week 4.

conclusionOur pilot study showed that Musa sp. pseudo-stem core powder was feasible and well-tolerated as a dietary supplement, with potential for modulating the gut microbiota. Future adequately powered trials are warranted to evaluate its effect on mental health and to elucidate underlying biological mechanisms.

trial registrationThe trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623000454673) on 2 May 2023.