锡兰肉桂提取物对成年人血脂、血糖水平的影响及其安全性：一项随机、双盲、对照试验。

Effects of Cinnamomum zeylanicum (Ceylon cinnamon) extract on lipid profile, glucose levels and its safety in adults: A randomized, double-blind, controlled trial.

作者信息

Muthukuda Dimuthu, de Silva Chamini Kanatiwela, Ajanthan Saumiyah, Wijesinghe Namal, Dahanayaka Anuradha, Pathmeswaran Arunasalam

机构信息

Sri Jayawardenepura General Hospital, Nugegoda, Sri Lanka.

RemediumOne, Colombo, Sri Lanka.

出版信息

PLoS One. 2025 Jan 24;20(1):e0317904. doi: 10.1371/journal.pone.0317904. eCollection 2025.

DOI:10.1371/journal.pone.0317904

PMID:39854533

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11759401/

Abstract

BACKGROUND

Cinnamon has been studied as a possible way to control blood glucose and serum cholesterol levels. However, there are no well-conducted randomized controlled trials that can accurately measure the lipid and glucose-lowering effects of Cinnamomum zeylanicum (C. zeylanicum) extract. This study primarily aimed to evaluate the effect of a standardized C. zeylanicum extract on serum low-density lipoprotein cholesterol (LDL-C) levels and secondarily on other lipid parameters (high-density lipoprotein cholesterol (HDL-C), total cholesterol and triglycerides), glucose levels, anthropometric measures, blood pressure, and safety outcomes in individuals with an LDL level between 100-190mg/dL.

MATERIALS AND METHODS

This was a randomized, double-blinded, placebo-controlled clinical trial. Participants were allocated to either C. zeylanicum extract or placebo group (1:1 allocation ratio). They were advised to take two capsules per day (1000 mg/day, a dose based on prior clinical studies suggesting potential efficacy and safety). Reduction in LDL-C at 12 weeks (from the baseline value) was compared between the two groups using ANCOVA. A complete-case analysis was adhered to in analyzing the outcome data.

RESULTS

The mean age (SD) of the 150 participants was 50.4 (10.52) years, and 66% were females. Among the 127 participants assessed at 12 weeks, those in the C. zeylanicum extract arm had a lower LDL-C value than the placebo arm but the difference was not significant (the baseline adjusted mean difference was 6.05mg/dL; 95% CI: -2.43 to 14.52; p = 0.161). However, participants in the C. zeylanicum extract group showed significantly greater reductions in fasting blood sugar (FBS) levels (the baseline adjusted mean difference was 8.59mg/dL; 95% CI: 0.59 to 16.59; p = 0.036). There was a significant interaction effect between the supplement and participants' glycemic status, with individuals with type 2 diabetes mellitus (T2DM) who received C. zeylanicum extract experiencing a notable reduction in FBS levels (standardized coefficient: -63, 95% CI: -102 to -25; p = 0.002).

CONCLUSIONS

C. zeylanicum extract did not have significantly reduce LDL-C but demonstrated a significant FBS-lowering effect, particularly in individuals with T2DM, with a favorable safety profile.

TRIALS REGISTRATION

The trial was registered with the Sri Lanka Clinical Trials Registry: SLCTR/2021/011.

摘要

背景

肉桂已被研究作为控制血糖和血清胆固醇水平的一种可能方法。然而，尚无进行良好的随机对照试验能够准确测量锡兰肉桂（C. zeylanicum）提取物的降脂和降糖作用。本研究主要旨在评估标准化的C. zeylanicum提取物对血清低密度脂蛋白胆固醇（LDL-C）水平的影响，其次评估对其他血脂参数（高密度脂蛋白胆固醇（HDL-C）、总胆固醇和甘油三酯）、血糖水平、人体测量指标、血压以及LDL水平在100 - 190mg/dL之间个体的安全性结局的影响。

材料与方法

这是一项随机、双盲、安慰剂对照的临床试验。参与者被分配到C. zeylanicum提取物组或安慰剂组（分配比例为1:1）。建议他们每天服用两粒胶囊（1000mg/天，该剂量基于先前临床研究提示的潜在疗效和安全性）。使用协方差分析比较两组在12周时（相对于基线值）LDL-C的降低情况。在分析结局数据时采用完全病例分析。

结果

150名参与者的平均年龄（标准差）为50.4（10.52）岁，66%为女性。在12周时评估的127名参与者中，C. zeylanicum提取物组的LDL-C值低于安慰剂组，但差异不显著（基线调整后的平均差异为6.05mg/dL；95%置信区间：-2.43至14.52；p = 0.161）。然而，C. zeylanicum提取物组的参与者空腹血糖（FBS）水平显著降低更多（基线调整后的平均差异为8.59mg/dL；95%置信区间：0.59至16.59；p = 0.036）。补充剂与参与者的血糖状态之间存在显著的交互作用，接受C. zeylanicum提取物的2型糖尿病（T2DM）个体的FBS水平显著降低（标准化系数：-63，95%置信区间：-102至-25；p = 0.002）。