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Please use this identifier to cite or link to this item: https://hdl.handle.net/2445/196614
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
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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.
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GIL LESPINARD, Mercedes, et al. 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. Contemporary Clinical Trials Communications. 2022. Vol. 30, num. 101034. ISSN 2451-8654. [consulted: 9 of August of 2026]. Available at: https://hdl.handle.net/2445/196614