Journal of Korean Medicine for Obesity Research (한방비만학회지)

The Society of Korean Medicine for obesity Research (한방비만학회)
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Effect of Lythrum salicaria Extract on Body Fat Reduction: A Protocol for a Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

체지방 감소에 대한 털부처꽃 추출물의 효과: 무작위배정, 이중눈가림, 대조군 비교 인체적용시험 프로토콜

  • Hye-Jin Park (Pusan National University) ;
  • In Heo (Pusan National University) ;
  • Yea-Jin Park (Department of Rehabilitation Medicine of Korean Medicine and Neuropsychiatry, College of Korean Medicine, Sangji University) ;
  • Hyo-Jin An (Department of Oriental Pharmaceutical Science, College of Pharmacy, Kyung Hee University) ;
  • Su Shin (Research Institute, Bio Port Korea Inc.) ;
  • Yun-Yeop Cha (Department of Rehabilitation Medicine of Korean Medicine and Neuropsychiatry, College of Korean Medicine, Sangji University)
  • 박혜진 (부산대학교) ;
  • 허인 (부산대학교) ;
  • 박예진 (상지대학교 한의과대학 한방재활의학교실) ;
  • 안효진 (경희대학교 약학대학 한약학과) ;
  • 신수 ((주)바이오포트코리아 기업부설연구소) ;
  • 차윤엽 (상지대학교 한의과대학 한방재활의학교실)
  • Received : 2024.05.18
  • Accepted : 2024.06.08
  • Published : 2024.06.30
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Abstract

Objectives: Obesity is a globally prevalent public health issue. Hence, there is a need for the development of safer and more effective anti-obesity drugs. Lythrum salicaria, a traditional medicinal herb used for centuries, has been reported to improve lipid metabolism and fat accumulation. It also has a low toxicity profile. Therefore, its potential as a functional ingredient in health functional foods needs to be evaluated. Methods: In this randomized, double-blind, placebo-controlled clinical trial, 90 participants will be randomly assigned to either the experimental or control group. Each subject will orally receive L. salicaria extract (1,350 mg/day) (500 mg L. salicaria+850 mg lactose as vehicle) or lactose (1,350 mg/day) as a hard capsule formula for 84 days (12 weeks). The primary outcome will be body fat mass (kg), which will be assessed using dual-energy x-ray absorptiometry (DXA) (performed only at visits 2 and 4). Secondary outcomes include body mass index, body weight, waist-to-hip ratio, body fat percentage (%) measured using DXA, lean body mass (kg) measured using DXA (assessed only at visits 2 and 4), lipids (total cholesterol, triglyceride, high-density lipoprotein cholesterol, and calculated low-density lipoprotein cholesterol), free fatty acid, high sensitivity C-reactive protein, adiponectin, and leptin. Conclusions: This protocol will be implemented after approval of Institutional Review Board of Pusan National University Korean Medicine Hospital (approval number: PNUKHIRB-2022-08-002) and registration with the Korean National Clinical Research Information Service (CRIS) (CRIS-KCT0008060). The results of this trial will provide potential of L. salicaria as a new anti-obesity functional food with fat-reducing effects and low toxicity.

Keywords

Acknowledgement

This work was carried out with the support of "Cooperative Research Program for Agriculture Science & Technology Development (Project No. RS-2021-RD009072)" Rural Development Administration, Korea.

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