RESUMO
AIM: 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). MATERIALS AND METHODS: 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. RESULTS: 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 2 = 0.11 and f 2 = 0.13 respectively) in comparison with BW and BMI. CONCLUSIONS: 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.
