Jeffrey Cheah School of Medicine and Health Sciences, Department of General Practice, Monash University, Sunway Campus, Bandar Sunway, Malaysia.
Department of Medicine, Clinical Research Centre, Melaka General Hospital, Melaka, Malaysia.
Diabetes Obes Metab. 2023 Nov;25(11):3298-3306. doi: 10.1111/dom.15229. Epub 2023 Aug 8.
Evidence from the literature points towards a viable choice of utilizing Labisia pumila to improve the metabolic profile in animal studies. To that end, this prospective study was designed to assess the health impact of the consumption of L. pumila standardized extract (SKF7®) on key parameters of obesity in humans such as body weight (BW), body mass index (BMI), waist circumference (WC) and waist-to-height ratio (WHtR).
A dose-ranging analysis using SKF7® was conducted through a randomized, double-blind, multicentre, placebo-controlled, phase 2 clinical trial involving individuals with obesity (N = 133) between January 2020 and April 2021. The potential percentage of change was assessed in relation to BW, BMI, WC and WHtR.
Average treatment effect estimates (treatment group vs. placebo) show a statistically significant reduction in the percentage of change for BW (mean = -2.915; CI: -4.546, -1.285), BMI (-2.921; CI: -4.551, -1.291), WC (mean = -2.187; CI: -3.784, -0.589) and WHtR (mean = -2.294, CI: -3.908, -0.681) in the group with a total of 750 mg of SKF7® (p < .01). An incremental reduction in WC and WHtR was consistent with the gradual increase in the total daily concentration of SKF7® from 375 to 750 mg. WC and WHtR had higher effect size (f = 0.11 and f = 0.13 respectively) in comparison with BW and BMI.
SKF7® is potentially a novel therapeutic treatment for obesity, reflected by reductions in BW, BMI, WC and WHtR. The use of SKF7® suggests a dose-dependent reduction in abdominal obesity, exemplified by a decline in WC and WHtR.
文献证据表明，利用白背叶（Labisia pumila）来改善动物研究中的代谢特征是一种可行的选择。为此，本前瞻性研究旨在评估食用白背叶标准化提取物（SKF7®）对人体肥胖关键参数的健康影响，如体重（BW）、体重指数（BMI）、腰围（WC）和腰高比（WHtR）。
2020 年 1 月至 2021 年 4 月，采用 SKF7®进行了一项随机、双盲、多中心、安慰剂对照、2 期临床试验，共纳入 133 名肥胖个体，进行了剂量范围分析。评估了 BW、BMI、WC 和 WHtR 的潜在百分比变化。
平均治疗效果估计（治疗组与安慰剂组）显示，BW（平均= -2.915；CI：-4.546，-1.285）、BMI（-2.921；CI：-4.551，-1.291）、WC（平均= -2.187；CI：-3.784，-0.589）和 WHtR（平均= -2.294，CI：-3.908，-0.681）的百分比变化均有统计学意义，表明 SKF7® 总剂量为 750mg 的治疗组与安慰剂组相比（p<.01）。随着 SKF7® 每日总浓度从 375mg 增加到 750mg，WC 和 WHtR 的逐渐减少与 WC 和 WHtR 的一致性一致。与 BW 和 BMI 相比，WC 和 WHtR 的效应量更高（f=0.11 和 f=0.13）。
SKF7® 可能是一种新型肥胖治疗药物，可降低 BW、BMI、WC 和 WHtR。SKF7® 的使用表明，腹部肥胖呈剂量依赖性下降，WC 和 WHtR 下降。
