Sophie Hiel1, Marco A Gianfrancesco2, Julie Rodriguez1, Daphnée Portheault3, Quentin Leyrolle1, Laure B Bindels1, Carolina Gomes da Silveira Cauduro3, Maria D G H Mulders4, Giorgia Zamariola5, Anne-Sophie Azzi6, Gaetan Kalala7, Barbara D Pachikian8, Camille Amadieu1, Audrey M Neyrinck1, Audrey Loumaye9, Patrice D Cani10, Nicolas Lanthier11, Pierre Trefois12, Olivier Klein4, Olivier Luminet5, Jérôme Bindelle7, Nicolas Paquot2, Miriam Cnop13, Jean-Paul Thissen9, Nathalie M Delzenne14. 1. Metabolism and Nutrition Research Group, Louvain Drug Research Institute, UCLouvain, Université catholique de Louvain, Brussels, Belgium. 2. Laboratory of Diabetology, Nutrition and Metabolic disease, Liège, Université de Liège, Belgium. 3. ULB Center for Diabetes Research, Université Libre de Bruxelles, Belgium. 4. Center for Social and Cultural Psychology, Université libre de Bruxelles, Belgium. 5. Research Institute for Psychological Sciences, UCLouvain, Université catholique de Louvain, Louvain-La-Neuve, Belgium. 6. Division of Endocrinology, Erasmus Hospital, Université Libre de Bruxelles, Brussels, Belgium. 7. Gembloux Agro-Bio Tech, Université de Liège, Gembloux, Belgium. 8. Centre d'Investigation Clinique en Nutrition, UCLouvain, Université catholique de Louvain, Louvain-La-Neuve, Belgium. 9. Pole of Endocrinology, Diabetes and Nutrition, Institut de Recherche Expérimentale et clinique, UCLouvain, Université catholique de Louvain, Brussels, Belgium. 10. Metabolism and Nutrition Research Group, Louvain Drug Research Institute, UCLouvain, Université catholique de Louvain, Brussels, Belgium; WELBIO- Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium. 11. Laboratory of Hepatogastroenterology, Institut de recherche expérimentale et clinique, UCLouvain, Université catholique de Louvain, Brussels, Belgium. 12. Medical Imaging Department, Cliniques Universitaires St-Luc, Brussels, Belgium. 13. ULB Center for Diabetes Research, Université Libre de Bruxelles, Belgium; Division of Endocrinology, Erasmus Hospital, Université Libre de Bruxelles, Brussels, Belgium. 14. Metabolism and Nutrition Research Group, Louvain Drug Research Institute, UCLouvain, Université catholique de Louvain, Brussels, Belgium. Electronic address: nathalie.delzenne@uclouvain.be.
Abstract
BACKGROUND: The gut microbiota is altered in obesity and is strongly influenced by nutrients and xenobiotics. We have tested the impact of native inulin as prebiotic present in vegetables and added as a supplement on gut microbiota-related outcomes in obese patients. Metformin treatment was analyzed as a potential modulator of the response. METHODS: A randomized, single-blinded, multicentric, placebo-controlled trial was conducted in 150 obese patients who received16 g/d native inulin versus maltodextrin, coupled to dietary advice to consume inulin-rich versus -poor vegetables for 3 months, respectively, in addition to dietary caloric restriction. Anthropometry, diagnostic imaging (abdominal CT-scan, fibroscan), food-behavior questionnaires, serum biology and fecal microbiome (primary outcome; 16S rDNA sequencing) were analyzed before and after the intervention. RESULTS: Both placebo and prebiotic interventions lowered energy intake, BMI, systolic blood pressure, and serum γ-GT. The prebiotic induced greater weight loss and additionally decreased diastolic blood pressure, AST and insulinemia. Metformin treatment compromised most of the gut microbiota changes and metabolic improvements linked to prebiotic intervention. The prebiotic modulated specific bacteria, associated with the improvement of anthropometry (i.e. a decrease in Desulfovibrio and Clostridium sensu stricto). A large increase in Bifidobacterium appears as a signature of inulin intake rather than a driver of prebiotic-linked biological outcomes. CONCLUSIONS:Inulin-enriched diet is able to promote weight loss in obese patients, the treatment efficiency being related to gut microbiota characteristics. This treatment is more efficacious in patients who did not receivemetformin as anti-diabetic drugs prior the intervention, supporting that both drug treatment and microbiota might be taken into account in personalized nutrition interventions. Registered under ClinicalTrials.gov Identifier no NCT03852069.
RCT Entities:
BACKGROUND: The gut microbiota is altered in obesity and is strongly influenced by nutrients and xenobiotics. We have tested the impact of native inulin as prebiotic present in vegetables and added as a supplement on gut microbiota-related outcomes in obesepatients. Metformin treatment was analyzed as a potential modulator of the response. METHODS: A randomized, single-blinded, multicentric, placebo-controlled trial was conducted in 150 obesepatients who received 16 g/d native inulin versus maltodextrin, coupled to dietary advice to consume inulin-rich versus -poor vegetables for 3 months, respectively, in addition to dietary caloric restriction. Anthropometry, diagnostic imaging (abdominal CT-scan, fibroscan), food-behavior questionnaires, serum biology and fecal microbiome (primary outcome; 16S rDNA sequencing) were analyzed before and after the intervention. RESULTS: Both placebo and prebiotic interventions lowered energy intake, BMI, systolic blood pressure, and serum γ-GT. The prebiotic induced greater weight loss and additionally decreased diastolic blood pressure, AST and insulinemia. Metformin treatment compromised most of the gut microbiota changes and metabolic improvements linked to prebiotic intervention. The prebiotic modulated specific bacteria, associated with the improvement of anthropometry (i.e. a decrease in Desulfovibrio and Clostridium sensu stricto). A large increase in Bifidobacterium appears as a signature of inulin intake rather than a driver of prebiotic-linked biological outcomes. CONCLUSIONS: Inulin-enriched diet is able to promote weight loss in obesepatients, the treatment efficiency being related to gut microbiota characteristics. This treatment is more efficacious in patients who did not receive metformin as anti-diabetic drugs prior the intervention, supporting that both drug treatment and microbiota might be taken into account in personalized nutrition interventions. Registered under ClinicalTrials.gov Identifier no NCT03852069.
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