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Effects of a (poly)phenol-rich supplement on anthropometric, biochemical, and inflammatory parameters in participants with morbid obesity: Study protocol for a randomised controlled trial Gil Lespinard, Mercedes Bambarén Capurro, Carlos Montserrat, Mónica Virgili Casas, Núria Zamora-Ros, Raul Obesitat mòrbida Assaigs clínics Marcadors bioquímics Metabolòmica Morbid obesity Clinical trials Biochemical markers Metabolomics Background: Morbid obesity (body mass index >= 40 kg/m2) represents a severe health risk and implies the need of urgent therapeutic action. (Poly)phenols may play a relevant role in the management of this disease modulating physiological and molecular pathways involved in energy metabolism and adiposity. The purpose of this double -blinded, placebo-controlled, randomised trial is to determine if (poly)phenol supplementation, in combination with a dietary intervention, can improve anthropometric and cardiometabolic parameters in participants with morbid obesity. Methods: Adults (n = 40) with morbid obesity, bariatric surgery candidates, will be recruited from the Bellvitge University Hospital, Spain, and randomly assigned (stratified by sex) to intervention (poly)phenol-rich supple-ment 1,200 mg/day + hypocaloric diet) or control group (placebo + hypocaloric diet) for 12 weeks. The primary outcome is body weight. Secondary outcomes are: other anthropometric markers and body composition measured through standardized methods and a bioimpedance analysis, cardiometabolic and inflammatory bio-markers, metabolic pathways, and gut microbiota diversity. Anthropometric parameters, dietary, physical ac-tivity and lifestyle questionnaires, blood pressure, and blood and urine samples will be collected at baseline, 6 weeks, and 12 weeks. Faecal samples will be collected at baseline and at 12 weeks. Informed consent of par-ticipants will be obtained before the start of the study.Discussion:: The present study is expected to provide evidence on the effects of a combination of (poly)phenols on several well-established obesity and cardiometabolic markers, and to unravel possible underlying mechanisms by metabolomic analyses. Gut microbiota diversity will be considered as a potential future endpoint. The study will contribute to future strategies for prevention or treatment of obesity and related conditions. 2023-04-12T11:09:48Z 2023-04-12T11:09:48Z 2022-12-01 2023-04-06T15:00:10Z info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion 2451-8654 https://hdl.handle.net/2445/196614 36387986 eng Reproducció del document publicat a: https://doi.org/10.1016/j.conctc.2022.101034 Contemporary Clinical Trials Communications, 2022, vol. 30, p. 101034 https://doi.org/10.1016/j.conctc.2022.101034 cc by-nc-nd (c) Gil Lespinard, Mercedes et al., 2022 http://creativecommons.org/licenses/by-nc-nd/3.0/es/ info:eu-repo/semantics/openAccess 8 p. application/pdf Elsevier BV Articles publicats en revistes (Nutrició, Ciències de l'Alimentació i Gastronomia)