Gil-Lespinard Mercedes, Bambarén Capurro Carlos, Montserrat Mónica, Virgili-Casas Núria, Zamora-Ros Raul
Unit of Nutrition and Cancer, Cancer Epidemiology Research Programme, Catalan Institute of Oncology (ICO), Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.
Endocrinology and Nutrition Service, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
Contemp Clin Trials Commun. 2022 Nov 8;30:101034. doi: 10.1016/j.conctc.2022.101034. eCollection 2022 Dec.
Morbid obesity (body mass index ≥40 kg/m) 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.
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 supplement 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 biomarkers, metabolic pathways, and gut microbiota diversity. Anthropometric parameters, dietary, physical activity 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 participants will be obtained before the start of the study.
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.
病态肥胖（体重指数≥40kg/m²）代表着严重的健康风险，意味着需要采取紧急治疗措施。（多）酚类物质可能在该疾病的管理中发挥重要作用，调节参与能量代谢和肥胖的生理及分子途径。这项双盲、安慰剂对照、随机试验的目的是确定补充（多）酚类物质并结合饮食干预是否能改善病态肥胖参与者的人体测量和心脏代谢参数。
将从西班牙贝尔维特奇大学医院招募40名病态肥胖的成年人，他们均为减肥手术候选人，并按性别分层随机分配至干预组（每天服用1200mg富含（多）酚类物质的补充剂+低热量饮食）或对照组（安慰剂+低热量饮食），为期12周。主要结局指标是体重。次要结局指标包括：通过标准化方法和生物电阻抗分析测量的其他人体测量指标和身体成分、心脏代谢和炎症生物标志物、代谢途径以及肠道微生物群多样性。将在基线、6周和12周时收集人体测量参数、饮食、身体活动和生活方式问卷、血压以及血液和尿液样本。将在基线和12周时收集粪便样本。在研究开始前将获得参与者的知情同意。
本研究预计将提供关于（多）酚类物质组合对多种公认的肥胖和心脏代谢标志物影响的证据，并通过代谢组学分析揭示可能的潜在机制。肠道微生物群多样性将被视为一个潜在的未来终点。该研究将有助于制定未来预防或治疗肥胖及相关病症的策略。
