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一项为期12周的单中心、随机、双盲、安慰剂对照、平行设计临床试验,旨在评估SKO-001在减少体脂方面的疗效和安全性。

A 12-Week, Single-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Design Clinical Trial for the Evaluation of the Efficacy and Safety of SKO-001 in Reducing Body Fat.

作者信息

Shin Seon Mi, Park Jeong-Su, Kim Sang Back, Cho Young Hee, Seo Hee, Lee Hak Sung

机构信息

Department of Internal Medicine, College of Korean Medicine, Semyung University, Semyeong-ro 65, Jecheon-si 27136, Republic of Korea.

Department of Preventive Medicine, College of Korean Medicine, Semyung University, Semyeong-ro 65, Jecheon-si 27136, Republic of Korea.

出版信息

Nutrients. 2024 Apr 11;16(8):1137. doi: 10.3390/nu16081137.

DOI:10.3390/nu16081137
PMID:38674828
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11053414/
Abstract

There is growing evidence linking gut microbiota to overall health, including obesity risk and associated diseases. SKO-001, a probiotic strain isolated from , has been reported to reduce obesity by controlling the gut microbiome. In this double-blind, randomised clinical trial, we aimed to evaluate the efficacy and safety of SKO-001 in reducing body fat. We included 100 participants randomised into SKO-001 or placebo groups (1:1) for 12 weeks. Dual-energy X-ray absorptiometry was used to objectively evaluate body fat reduction. Body fat percentage ( = 0.016), body fat mass ( = 0.02), low-density lipoprotein-cholesterol levels ( = 0.025), and adiponectin levels ( = 0.023) were lower in the SKO-001 group than in the placebo group after 12 weeks of SKO-001 consumption. In the SKO-001 group, the subcutaneous fat area ( = 0.003), total cholesterol levels ( = 0.003), and leptin levels ( = 0.014) significantly decreased after 12 weeks of SKO-001 consumption compared with baseline values. Additionally, SKO-001 did not cause any severe adverse reactions. In conclusion, SKO-001 is safe and effective for reducing body fat and has the potential for further clinical testing in humans.

摘要

越来越多的证据表明肠道微生物群与整体健康相关,包括肥胖风险及相关疾病。SKO-001是一种从……分离出的益生菌菌株,据报道它可通过控制肠道微生物群来减轻肥胖。在这项双盲随机临床试验中,我们旨在评估SKO-001在减少体脂方面的疗效和安全性。我们纳入了100名参与者,将他们随机分为SKO-001组或安慰剂组(1:1),为期12周。采用双能X线吸收法客观评估体脂减少情况。服用SKO-001 12周后,SKO-001组的体脂百分比(P = 0.016)、体脂量(P = 0.02)、低密度脂蛋白胆固醇水平(P = 0.025)和脂联素水平(P = 0.023)均低于安慰剂组。在SKO-001组中,服用SKO-001 12周后,皮下脂肪面积(P = 0.003)、总胆固醇水平(P = 0.003)和瘦素水平(P = 0.014)与基线值相比显著降低。此外,SKO-001未引起任何严重不良反应。总之,SKO-001在减少体脂方面安全有效,具有在人体中进一步进行临床试验的潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d03/11053414/66e663a933ee/nutrients-16-01137-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d03/11053414/9b77f39fa711/nutrients-16-01137-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d03/11053414/ed2c1c401224/nutrients-16-01137-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d03/11053414/534f69bcbb83/nutrients-16-01137-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d03/11053414/66e663a933ee/nutrients-16-01137-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d03/11053414/9b77f39fa711/nutrients-16-01137-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d03/11053414/ed2c1c401224/nutrients-16-01137-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d03/11053414/534f69bcbb83/nutrients-16-01137-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d03/11053414/66e663a933ee/nutrients-16-01137-g004.jpg

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