Emamat Hadi, Zahedmehr Ali, Asadian Sanaz, Tangestani Hadith, Nasrollahzadeh Javad
Department of Clinical Nutrition & Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, P.O. 19395-4741, Iran.
Cardiovascular Intervention Research Center, Shahid Rajaei Cardiovascular, Medical & Research Center, Iran University of Medical Sciences, Tehran, Iran.
Trials. 2020 Nov 27;21(1):986. doi: 10.1186/s13063-020-04918-7.
Cardiovascular diseases (CVDs) remain the leading causes of morbidity and mortality in the world. Hypertension is an important and prevalent cardiovascular risk factor. The present study will be conducted to investigate the effect of barberry as a cardio-protective fruit on the blood pressure in patients with hypertension and other CVD risk factors. Furthermore, plasma concentrations of lipids and inflammatory biomarkers will be evaluated.
METHODS/DESIGN: This is an 8-week, prospective, single-blinded, parallel assigned, randomized controlled clinical trial (RCT) in which eligible men and women with hypertension and other cardiovascular risk factors will be randomized to either placebo powder (PP; containing 9 g maltodextrin, 1 g citric acid, 1 g milled sucrose and edible red color (n = 37)) or barberry powder (BP; containing 10 g milled dried barberry and 1 g of milled sucrose (n = 37)) groups. At baseline and after 8 weeks of intervention, plasma lipids and inflammatory markers, 24-h urinary nitrite/nitrate and sodium excretion, and 24-h ambulatory blood pressure monitoring (ABPM) will be measured. Anthropometric measures and dietary assessment will be performed as well. Data analysis will be done using SPSS version-21 software.
The interest in natural and functional food products has increased globally. This RCT will add to the growing literature for the potential antihypertensive, lipid-lowering, and anti-inflammatory effects of barberry in humans.
ClinicalTrials.gov (NCT number) NCT04084847 . Registered on 10 December 2019.
心血管疾病（CVDs）仍然是全球发病和死亡的主要原因。高血压是一种重要且普遍的心血管危险因素。本研究旨在调查作为具有心脏保护作用的果实的醋栗对高血压及其他心血管疾病危险因素患者血压的影响。此外，还将评估血脂和炎症生物标志物的血浆浓度。
方法/设计：这是一项为期8周的前瞻性、单盲、平行分组、随机对照临床试验（RCT），符合条件的患有高血压及其他心血管疾病危险因素的男性和女性将被随机分为安慰剂粉末组（PP；含9克麦芽糊精、1克柠檬酸、1克磨碎的蔗糖和食用红色素（n = 37））或醋栗粉末组（BP；含10克磨碎的干醋栗和1克磨碎的蔗糖（n = 37））。在基线和干预8周后，将测量血脂和炎症标志物、24小时尿亚硝酸盐/硝酸盐和钠排泄量，以及24小时动态血压监测（ABPM）。还将进行人体测量和饮食评估。数据分析将使用SPSS 21版软件进行。
全球对天然和功能性食品的兴趣有所增加。这项RCT将为醋栗对人类潜在的降压、降脂和抗炎作用的不断增加的文献增添内容。
ClinicalTrials.gov（NCT编号）NCT04084847。于2019年12月10日注册。
