随机双盲安慰剂对照临床试验:补充纳米姜黄素对超重或肥胖冠状动脉慢流现象患者心绞痛状况以及传统和新型心血管风险因素的影响。

IF 1.9 Q3 NUTRITION & DIETETICS
Mahsa Rezaei, Mitra Soltani, Elham Alipoor, Seyed Mahdi Rezayat, Ali Vasheghani-Farahani, Mehdi Yaseri, Ata Firouzi, Mohammad Javad Hosseinzadeh-Attar
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引用次数: 0

摘要

背景:冠状动脉慢血流现象(CSFP)患者经常发生心血管事件,生活质量低下。本试验评估了含有姜黄素的纳米姜黄素补充剂作为多功能营养保健品对超重或肥胖 CSFP 患者心绞痛状况以及一些传统和新型心血管风险因素的影响:在这项双盲、随机、安慰剂对照临床试验中,42名超重或肥胖的CSFP患者每天服用80毫克纳米姜黄素或安慰剂,为期12周。干预前后评估了西雅图心绞痛问卷(SAQ)(作为心绞痛状态的临床测量指标)、循环内皮素、腺苷、同型半胱氨酸、血脂概况以及内脏脂肪指数(VAI)和腰部甘油三酯指数(WTI)的新评分。在适当的情况下使用了独立样本 t 检验、曼-惠特尼检验、协方差分析、卡方检验和费雪精确检验:结果:与安慰剂组相比,纳米姜黄素组的所有 SAQ 领域(包括身体限制、心绞痛稳定性、心绞痛频率-严重性、治疗满意度、疾病感知和生活质量)均有显著改善。干预后,血清内皮素、阿糖腺苷和同型半胱氨酸未见明显变化。只有纳米姜黄素组的甘油三酯、甘油三酯/高密度脂蛋白胆固醇比率、WTI和VAI值有明显改善:连续 12 周每天补充 80 毫克纳米姜黄素(含姜黄素)可明显改善 CSFP 患者的临床重要疾病特异性健康状况。与基线值相比,一些传统和新型心血管风险因素仅有明显改善,这需要进一步研究:本研究获得了德黑兰医科大学伦理委员会(IR.TUMS.VCR.REC.1398.794)的批准。研究方案已于 2019 年 6 月 19 日在伊朗临床试验注册中心(IRCT20131125015536N8)注册,注册编号为 IRCT20131125015536N8。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Effect of nano-curcumin supplementation on angina status, and traditional and novel cardiovascular risk factors in overweight or obese patients with coronary slow flow phenomenon: a randomized double-blind placebo-controlled clinical trial.

Background: Cardiovascular events and poor quality of life are frequently observed in patients with coronary slow flow phenomenon (CSFP). This trial evaluated the effect of nano-curcumin supplement containing curcuminoids, as multifunctional nutraceuticals, on angina status, and some traditional and novel cardiovascular risk factors in overweight or obese patients with CSFP.

Methods: In this double-blind, randomized, placebo-controlled clinical trial, 42 overweight or obese patients with CSFP received either 80 mg/day of nano-curcumin or placebo for 12 weeks. Seattle angina questionnaire (SAQ) as a clinical measure of angina status, circulating endocan, adropin, homocysteine, lipid profile, and the novel scores of visceral adiposity index (VAI) and waist-triglyceride index (WTI) were assessed before and after the intervention. The independent samples t-test, Mann-Whitney test, analysis of covariance, Chi-square, and Fisher's exact tests were used where appropriate.

Results: All domains of SAQ including physical limitation, angina stability, angina frequency-severity, treatment satisfaction, and disease perception and quality of life improved significantly in the nano-curcumin compared with the placebo group. No significant changes were observed in serum endocan, adropin, and homocysteine following the intervention. Triglycerides, triglyceride/high-density lipoprotein cholesterol ratio, WTI and VAI values improved significantly only within the nano-curcumin group.

Conclusions: Supplementation with 80 mg/day nano-curcumin (containing curcuminoids) for 12 weeks significantly improved clinically important disease-specific aspects of health in patients with CSFP. Some traditional and novel cardiovascular risk factors improved significantly only compared with the baseline values, which need further investigation.

Trial registration: This study was approved by the Ethics Committee of Tehran University of Medical Sciences (IR.TUMS.VCR.REC.1398.794). The study protocol was registered at Iranian Registry of Clinical Trials by IRCT20131125015536N8 registration ID at 19.06.2019.

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来源期刊
BMC Nutrition
BMC Nutrition Medicine-Public Health, Environmental and Occupational Health
CiteScore
2.80
自引率
0.00%
发文量
131
审稿时长
15 weeks
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