Effect of Lythrum salicaria Extract on Body Fat Reduction: A Protocol for a Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

• 영문명: 체지방 감소에 대한 털부처꽃 추출물의 효과: 무작위배정, 이중눈가림, 대조군 비교 인체적용시험 프로토콜
• 발행기관: 한방비만학회
• 저자명: 박혜진 허인 박예진 안효진 신수 차윤엽
• 간행물 정보: 『대한한방비만학회지』제24권 제1호, 87~93쪽, 전체 7쪽
• 주제분류: 의약학 > 한의학
• 파일형태: PDF
• 발행일자: 2024.06.30

국문 초록

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.

목차

Introduction

Materials and Methods

Discussion

References

키워드

Lythrum salicaria Body fat reduction Randomized controlled trial Obesity