Mena Pedro, Tassotti Michele, Martini Daniela, Rosi Alice, Brighenti Furio, Del Rio Daniele
Human Nutrition Unit, Department of Food and Drugs, University of Parma, Medical School Building C, Via Volturno, 39, 43125, Parma, Italy.
Trials. 2017 Nov 9;18(1):527. doi: 10.1186/s13063-017-2271-2.
Coffee is an important source of bioactive compounds, including caffeine, phenolic compounds (mainly chlorogenic acids), trigonelline, and diterpenes. Several studies have highlighted the preventive effects of coffee consumption on major cardiometabolic diseases, but the impact of coffee dosage on markers of cardiometabolic risk is not well understood. Moreover, the pool of coffee-derived circulating metabolites and the contribution of each metabolite to disease prevention still need to be evaluated in real-life settings. The aim of this study will be to define the bioavailability and beneficial properties of coffee bioactive compounds on the basis of different levels of consumption, by using an innovative experimental design. The contribution of cocoa-based products containing coffee to the pool of circulating metabolites and their putative bioactivity will also be investigated.
A three-arm, crossover, randomized trial will be conducted. Twenty-one volunteers will be randomly assigned to consume three treatments in a random order for 1 month: 1 cup of espresso coffee/day, 3 cups of espresso coffee/day, and 1 cup of espresso coffee plus 2 cocoa-based products containing coffee twice per day. The last day of each treatment, blood and urine samples will be collected at specific time points, up to 24 hours following the consumption of the first product. At the end of each treatment the same protocol will be repeated, switching the allocation group. Besides the bioavailability of the coffee/cocoa bioactive compounds, the effect of the coffee/cocoa consumption on several cardiometabolic risk factors (anthropometric measures, blood pressure, inflammatory markers, trimethylamine N-oxide, nitric oxide, blood lipids, fasting indices of glucose/insulin metabolism, DNA damage, eicosanoids, and nutri-metabolomics) will be investigated.
Results will provide information on the bioavailability of the main groups of phytochemicals in coffee and on their modulation by the level of consumption. Findings will also show the circulating metabolites and their bioactivity when coffee consumption is substituted with the intake of cocoa-based products containing coffee. Finally, the effect of different levels of 1-month coffee consumption on cardiometabolic risk factors will be elucidated, likely providing additional insights on the role of coffee in the protection against chronic diseases.
ClinicalTrials.gov, NCT03166540 . Registered on May 21, 2017.
咖啡是生物活性化合物的重要来源，包括咖啡因、酚类化合物（主要是绿原酸）、胡芦巴碱和二萜类化合物。多项研究强调了饮用咖啡对主要心脏代谢疾病的预防作用，但咖啡摄入量对心脏代谢风险标志物的影响尚不清楚。此外，源自咖啡的循环代谢物库以及每种代谢物对疾病预防的贡献仍需在实际生活环境中进行评估。本研究的目的是通过采用创新的实验设计，根据不同的饮用水平来确定咖啡生物活性化合物的生物利用度和有益特性。还将研究含咖啡的可可制品对循环代谢物库及其假定生物活性的贡献。
将进行一项三臂交叉随机试验。21名志愿者将被随机分配，以随机顺序接受三种治疗，为期1个月：每天1杯浓缩咖啡、每天3杯浓缩咖啡、每天1杯浓缩咖啡加2份含咖啡的可可制品，每天2次。每种治疗的最后一天，在食用第一种产品后的特定时间点（最长24小时）采集血液和尿液样本。每种治疗结束时，将重复相同的方案，更换分配组。除了咖啡/可可生物活性化合物的生物利用度外，还将研究饮用咖啡/可可对多种心脏代谢风险因素（人体测量指标、血压、炎症标志物、氧化三甲胺、一氧化氮、血脂、葡萄糖/胰岛素代谢的空腹指标、DNA损伤、类二十烷酸和营养代谢组学）的影响。
结果将提供关于咖啡中主要植物化学物质组的生物利用度及其受饮用水平调节的信息。研究结果还将显示，当用含咖啡的可可制品替代咖啡饮用时的循环代谢物及其生物活性。最后，将阐明1个月不同水平的咖啡饮用对心脏代谢风险因素的影响，可能会为咖啡在预防慢性病中的作用提供更多见解。
ClinicalTrials.gov，NCT03166540。于2017年5月21日注册。
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