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A diverse high-fibre plant-based dietary intervention improves gut microbiome composition, gut symptoms, energy and hunger in healthy adults: a randomised controlled trial

Diets low in diverse fibre-rich plant foods are a major factor in the rise of chronic diseases globally. The BIOME study ([NCT06231706][1]) was a 6-week, parallel design randomised controlled trial in 399 healthy adults in the UK, investigating a simple dietary intervention containing 30+ whole-food ingredients high in plant polyphenolic compounds, fibre and micronutrients. Participants were randomised to the primary intervention (prebiotic blend; 30g/d) or control (bread croutons; 28g/d; isocaloric functional equivalent) or a daily probiotic ( L. rhamnosu s). The primary outcome was change in ‘favourable’ and ‘unfavourable’ microbiome species compared to control, secondary outcomes included changes in blood metabolites, gut symptoms, stool output, anthropometric measures, subjective hunger, sleep, energy and mood. A crossover test meal challenge sub-study was conducted in 34 participants, investigating postprandial glucose responses, subjective hunger, satiety and mood. In the 349 male and female participants (mean age 50yrs) included in the analysis (intention-to-treat), self-reported adherence was high (> 98% for all treatments). Following the prebiotic blend, significant improvements were seen in the change and ranking of ‘favourable’ and ‘unfavourable’ species as well as beta diversity (weighted-UniFrac measure), but not in the control or probiotic group. There were significantly greater improvements in self reported indigestion, constipation, heartburn, flatulence and energy, following the prebiotic vs control, and hunger following the prebiotic vs probiotic. Addition of the prebiotic to a high carbohydrate test meal challenge resulted in significant improvements in subjective hunger, fullness, and energy (3h incremental area under the curve). No other significant differences between groups were observed. This prebiotic blend is a simple dietary strategy that benefits gut microbiome composition, gut symptoms and self-reported energy and hunger. ![Figure][2]</img> ### Competing Interest Statement T.D.S. and J.W. are co-founders of Zoe Ltd.. S.E.B., F.As., N.S. are consultants to ZOE Ltd., A.C.C., H.B., F.Am., M.W., A.A., H.A.S., A.P., W.J.B., K.M.B., J.C.P., A.R.L., C.J., C.C., N.K., I.L., F.G., and R.D., are or have been employees of ZOE Ltd. H.B., F.Am., A.A., M.W., H.A.S., A.P., W.J.B., K.M.B., J.C.P., A.R.L., I.L., F.G., F.As., J.W., N.S., S.E.B., and T.D.S. receive options with ZOE Ltd. ### Clinical Trial NCT06231706 ### Funding Statement This research was funded by ZOE limited. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Kings College London Research Ethics Committee (REC) of King's College London gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT06231706&atom=%2Fmedrxiv%2Fearly%2F2024%2F07%2F03%2F2024.07.02.24309816.atom [2]: pending:yes

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