The Effects of Saffron (Crocus sativus L) Supplementation on Cardiovascular Risk Factors, Liver Steatosis, and Fibrosis in Patients With Non-alcoholic Fatty Liver Disease: A Randomised, Double-Blind, Placebo-Controlled Study

IF 2.2 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Journal of Herbal Medicine Pub Date : 2024-03-30 DOI:10.1016/j.hermed.2024.100877
Reyhane Sadat Mirnasrollahi Parsa , Naheed Aryaeian , Marjan Mokhtare , Farnaz Kavianipour , Leila Janani , Shahram Agah , Nariman Moradi
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Abstract

Introduction

This study was designed to investigate the effects of Saffron supplementation on liver FibroScan test, liver enzymes, lipid profile, total and direct bilirubin, glycemic profile, and blood pressure in non-alcoholic fatty liver disease (NAFLD) patients. The researchers hypothesised that supplementation with Saffron could further improve the efficacy of lifestyle modifications in managing NAFLD.

Methods

This randomised, double-blind, placebo-controlled trial was conducted on 76 NAFLD patients, whose age range was from 18 to 65. All of them were given a specified weight loss diet and a physical activity programme. They were randomly assigned into two groups to intake 100 mg of a Saffron-coated tablet (n = 38) or a placebo tablet (n = 38) for 12 weeks. Liver FibroScan test, liver enzymes (as primary outcome), lipid profile, total and direct bilirubin, fasting blood sugar (FBS), insulin, insulin resistance (homoeostasis model assessment-insulin resistance), insulin sensitivity (quantitative insulin sensitivity check index), blood pressure, dietary intake, and physical activity were measured at baseline and also after 12 weeks. Both the participants and the dietitians were blindly assigned to the groups. Statistical analysis was carried out using SPSS software version 22.

Results

Finally, 36 patients completed the study, and 38 patients were included in the intention-to-treat analysis. Accordingly, Saffron supplementation reduced steatosis score (P > 0.001), steatosis percent (P > 0.001), steatosis stage (P > 0.001), total cholesterol (P = 0.001), triacylglycerol (P > 0.001), low-density lipoprotein (P = 0.005), and FBS (P = 0.009) more than placebo. There was no significant difference in liver fibrosis, aminotransferase (−1.33 IU/L, 95% CI = −5.10, 2.43, P = 0.482), aminotransferase (−0.20 IU/L, 95% CI = −2.94, 2.52, P = 0.880), γ-glutamyltransferase, insulin, homoeostasis model assessment-insulin resistance, and quantitative insulin sensitivity check indexes, total and direct bilirubin, and blood pressure between the two groups (P > 0.05).

Conclusions

Overall, the 12-week consumption of 100 mg Saffron, along with lifestyle modification, compared with placebo, had insignificant reducing effects on liver steatosis score, steatosis percent, steatosis stage, total cholesterol, triacylglycerol, low-density lipoprotein, and FBS among NAFLD patients. Saffron may exert considerable beneficial consequences that need further assessment in future clinical trials.

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补充藏红花(Crocus Sativus L)对非酒精性脂肪肝患者心血管风险因素、肝脏脂肪变性和纤维化的影响:一项随机、双盲、安慰剂对照研究
引言本研究旨在探讨补充藏红花对非酒精性脂肪肝(NAFLD)患者肝纤维扫描、肝酶、血脂、总胆红素和直接胆红素、血糖和血压的影响。研究人员假设,补充藏红花可进一步提高生活方式调整在控制非酒精性脂肪肝方面的疗效。方法这项随机、双盲、安慰剂对照试验的对象是 76 名非酒精性脂肪肝患者,他们的年龄在 18 岁至 65 岁之间。所有患者都接受了指定的减肥饮食和体育锻炼计划。他们被随机分为两组,分别服用 100 毫克藏红花包衣片(38 人)或安慰剂片(38 人),为期 12 周。在基线和 12 周后,对肝纤维扫描测试、肝酶(作为主要结果)、血脂概况、总胆红素和直接胆红素、空腹血糖(FBS)、胰岛素、胰岛素抵抗(胰岛素抵抗同源模型评估)、胰岛素敏感性(胰岛素敏感性定量检查指数)、血压、饮食摄入量和体力活动进行了测量。参与者和营养师均被盲法分配到各组。结果最终有 36 名患者完成了研究,38 名患者被纳入意向治疗分析。与安慰剂相比,补充藏红花可降低脂肪变性评分(P > 0.001)、脂肪变性百分比(P > 0.001)、脂肪变性阶段(P > 0.001)、总胆固醇(P = 0.001)、三酰甘油(P > 0.001)、低密度脂蛋白(P = 0.005)和 FBS(P = 0.009)。肝纤维化、转氨酶(-1.33 IU/L,95% CI = -5.10,2.43,P = 0.482)、转氨酶(-0.20 IU/L,95% CI = -2.94,2.52,P = 0.880)、γ-谷氨酰转移酶、胰岛素、稳态模型评估-胰岛素抵抗和胰岛素敏感性定量检查指标、总胆红素和直接胆红素以及血压在两组之间的差异(P > 0.05)。总之,与安慰剂相比,在非酒精性脂肪肝患者中,服用 12 周 100 毫克藏红花并同时改变生活方式,对肝脏脂肪变性评分、脂肪变性百分比、脂肪变性分期、总胆固醇、三酰甘油、低密度脂蛋白和 FBS 的降低效果不显著。藏红花可能具有相当大的益处,需要在未来的临床试验中进一步评估。
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来源期刊
Journal of Herbal Medicine
Journal of Herbal Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
3.90
自引率
0.00%
发文量
94
期刊介绍: The Journal of Herbal Medicine, the official journal of the National Institute of Medical Herbalists, is a peer reviewed journal which aims to serve its readers as an authoritative resource on the profession and practice of herbal medicine. The content areas of the journal reflect the interests of Medical Herbalists and other health professionals interested in the clinical and professional application of botanical medicines. The objective is to strengthen the research and educational base of herbal medicine with research papers in the form of case studies, original research articles and reviews, monographs, clinical trials and relevant in vitro studies. It also publishes policy statements, opinion pieces, book reviews, conference proceedings and profession related information such as pharmacovigilance reports providing an information source for not only the Herbal Practitioner but any Health professional with an interest in phytotherapy.
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