The effects of alpha-lipoic acid transdermal patch for local subcutaneous fat reduction: A randomized, placebo-controlled, clinical trial in overweight volunteers

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-11-24 DOI:10.1016/j.conctc.2024.101402
Kanidta Sooklert , Sasin Thamakaison , Siwaporn Nilyai , Sarocha Cherdchom , Rojrit Rojanathanes , Amornpun Sereemaspun
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Abstract

Background

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.

Methods

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.

Results

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.

Conclusion

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.
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α-硫辛酸透皮贴片对减少局部皮下脂肪的效果:针对超重志愿者的随机安慰剂对照临床试验
背景防治肥胖症具有挑战性,因为通过传统途径给药时,抗肥胖化合物会失去疗效或产生严重的副作用。因此,我们需要新的、有效的、可在家中长期安全使用的治疗途径。这项双盲、安慰剂对照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片在减少皮下脂肪堆积方面的疗效。他们被随机分配在手臂上贴上柠檬酸钙纳米胶囊 ALA 透皮贴或安慰剂。研究人员在基线和两周随访时记录了参与者的体重、身高、血脂(胆固醇、甘油三酯、低密度脂蛋白和高密度脂蛋白)、臂围、肱三头肌皮肤褶皱和皮下脂肪厚度。结论本研究报告了柠檬酸钙纳米胶囊 ALA 透皮贴片成功减少皮下脂肪的情况。这种透皮贴片可作为一种安全有效的家庭肥胖症防治方案。
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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