Clermont Auvergne, INRAE, UNH, Clermont-Ferrand, France.
Platform of Clinical Investigation Department, University Hospital Clermont-Ferrand, INSERM CIC 1405, Clermont-Ferrand, France.
BMJ Open. 2021 Nov 30;11(11):e053321. doi: 10.1136/bmjopen-2021-053321.
Although epidemiological studies associate the consumption of sugary beverages with adverse health effects, human experimental studies have demonstrated substantially different metabolic responses when 100% fruit juices are compared with artificial beverages. Fruit juices do not just provide sugars and associated calories, but they are also rich in bioactive compounds. Flavanones are bioactives specifically and abundantly found in citrus foods, with hesperidin as the major representative in sweet oranges. Flavanone intake has been associated with a lower incidence of mortality from cardiovascular disease (CVD). However, clinical evidence are too scarce to confirm the vasculoprotective effects of 100% orange juice (OJ) presumably mediated by flavanones and thereby do not allow firm conclusions to be drawn about their efficacy.
The HESPER-HEALTH study aims to assess the efficacy of OJ in improving vascular function and the contribution of hesperidin to these effects. This double-blind, randomised, controlled, crossover study will be carried out in 42 volunteers predisposed to CVD, based on age and on overweight. It includes three 6-week periods of consumption of 330 mL/d of OJ versus control drinks with and without hesperidin at a dose in agreement with a daily OJ serving (approx. 200-215 mg). The primary outcome is endothelial function, assessed by flow mediated dilation, with measurements performed at fasting and postprandially in response to a challenge meal. The secondary outcomes include bioavailability and metabolism of flavanones, changes in other markers of vascular function, systemic biomarkers of cardiovascular risk, endothelial dysfunction and inflammation, vitamin C and carotenoids status, anthropometry and body composition, gut microbiota composition, nutrigenomic response and in oxylipin profiling.
This ongoing study was approved by the Ethics committee Sud-Est III, Bron, France on 17 November 2020. The trial is registered on ClinicalTrials.gov. The results will be disseminated in peer-reviewed journals.
NCT04731987; Pre-results.
尽管流行病学研究表明，饮用含糖饮料与健康不良后果有关，但人类实验研究表明，当将 100%纯果汁与人工饮料进行比较时，代谢反应会有很大的不同。果汁不仅提供糖和相关卡路里，而且还富含生物活性化合物。类黄酮是柑橘类食物中特有的大量存在的生物活性物质，其中橙皮苷是甜橙中的主要代表。类黄酮的摄入与心血管疾病（CVD）死亡率降低有关。然而，临床证据还太少，无法证实 100%橙汁（OJ）的血管保护作用可能是通过类黄酮介导的，因此无法就其疗效得出明确的结论。
HESPER-HEALTH 研究旨在评估 OJ 改善血管功能的功效，以及橙皮苷对此类效果的贡献。这是一项双盲、随机、对照、交叉研究，将在 42 名易患 CVD 的志愿者中进行，入选标准为年龄和超重。它包括三个 6 周的周期，每天饮用 330 毫升/d 的 OJ 或对照饮料，同时摄入或不摄入与每日 OJ 剂量一致的橙皮苷（约 200-215 毫克）。主要结局是通过血流介导的扩张来评估内皮功能，在空腹和餐后进行测量，以响应挑战餐。次要结局包括类黄酮的生物利用度和代谢、其他血管功能标志物的变化、心血管风险的系统生物标志物、内皮功能障碍和炎症、维生素 C 和类胡萝卜素状态、人体测量和身体成分、肠道微生物群组成、营养基因组反应和氧化脂质谱。
这项正在进行的研究于 2020 年 11 月 17 日获得法国 Sud-Est III 伦理委员会的批准。该试验在 ClinicalTrials.gov 上注册。结果将在同行评议的期刊上发表。
NCT04731987；预结果。
