Sooklert Kanidta, Thamakaison Sasin, Nilyai Siwaporn, Cherdchom Sarocha, Rojanathanes Rojrit, Sereemaspun Amornpun
Center of Excellence in Nanomedicine, Department of Anatomy, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Department of Computer Science, School of Engineering, Stanford University, California, USA.
Contemp Clin Trials Commun. 2024 Nov 24;42:101402. doi: 10.1016/j.conctc.2024.101402. eCollection 2024 Dec.
Combating obesity is challenging, as anti-obesity compounds lose effectiveness or cause severe side effects when delivered via conventional routes. Thus, there is a need for new, effective treatment routes that are home-based and safe for long-term use. This double-blind, placebo-controlled clinical trial aimed to investigate the efficacy of a biocellulose transdermal patch containing α-lipoic acid (ALA), an anti-obesity compound, in reducing subcutaneous fat accumulation.
One hundred and sixteen overweight participants (average age 37.96 ± 7.80 years) were recruited for the study. They were randomly assigned to apply either the calcium citrate nanoparticle-encapsulated ALA transdermal patch or a placebo on their arm. The participants' body weight, height, blood lipid profile (cholesterol, triglyceride, low-density lipoprotein, and high-density lipoprotein), arm circumference, triceps skin fold, and subcutaneous fat thickness were recorded at baseline and at the 2-week follow-up.
The mean arm circumference did not show any significant difference from baseline, whereas the triceps skinfold and subcutaneous fat thickness showed a significant reduction. The 2-week treatment did not significantly alter the plasma LDL, HDL, and triglyceride levels of the participants, but it significantly reduced the total cholesterol level.
This study reports the successful reduction of subcutaneous fat of the calcium citrate nanoparticle-encapsulated ALA transdermal patches. The transdermal patches could be used as a safe and effective home-based solution for combating obesity.
对抗肥胖具有挑战性,因为抗肥胖化合物通过传统途径给药时会失去效力或引起严重的副作用。因此,需要新的、有效的治疗途径,这些途径以家庭为基础且长期使用安全。这项双盲、安慰剂对照的临床试验旨在研究含有抗肥胖化合物α-硫辛酸(ALA)的生物纤维素透皮贴剂在减少皮下脂肪堆积方面的疗效。
招募了116名超重参与者(平均年龄37.96±7.80岁)参与该研究。他们被随机分配在手臂上使用包裹柠檬酸钙纳米颗粒的ALA透皮贴剂或安慰剂。在基线和2周随访时记录参与者的体重、身高、血脂谱(胆固醇、甘油三酯、低密度脂蛋白和高密度脂蛋白)、手臂周长、三头肌皮褶厚度和皮下脂肪厚度。
平均手臂周长与基线相比没有显示出任何显著差异,而三头肌皮褶厚度和皮下脂肪厚度显示出显著降低。为期2周的治疗没有显著改变参与者的血浆低密度脂蛋白、高密度脂蛋白和甘油三酯水平,但显著降低了总胆固醇水平。
本研究报告了包裹柠檬酸钙纳米颗粒的ALA透皮贴剂成功减少了皮下脂肪。透皮贴剂可作为一种安全有效的以家庭为基础的抗肥胖解决方案。