title: Effects of acupuncture on serum metabolic parameters in premenopausal obese women: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Complex metabolic changes cause obesity, making weight loss difficult. For this reason, understanding metabolism is important, and considering the shortcomings of conventional treatment options for obesity, acupuncture is a possible option. However, evidence supporting its efficacy on metabolic parameters in obese patients is lacking. The aim of this study is to investigate the effects of acupuncture on serum metabolic parameters in premenopausal obese women.
  
  
  METHODS
  This ongoing study is a randomized, patient-assessor blind, two-arm parallel non-penetrating sham-controlled clinical trial. Eligible participants, premenopausal adult women (19 years of age or older) with a clinical diagnosis of obesity (body mass index of 25 kg/m(2) or more) blinded to the treatment received, will be randomly allocated blindly into the real acupuncture treatment group (manual acupuncture plus electroacupuncture, n = 60) or the sham acupuncture control group (sham acupuncture plus placebo acupuncture without electrical stimulation, n = 60) and receive treatment two times a week for a total of 12 sessions over 6 weeks. The primary outcome measure is the serum cholesterol and triglyceride (TG) levels at baseline and endpoint. The secondary outcomes are body weight, body fat mass, muscle mass, waist and hip circumference, other serum metabolic profiles, International Physical Activity Questionnaire (IPAQ), Social Readjustment Rating Scale (SRRS), Stress Response Inventory (SRI), Fatigue Severity Scale (FSS), the Korean version of the Beck Depression Inventory (BDI), and urine metabolites. Adverse events will be assessed at every visit.
  
  
  CONCLUSIONS
  The results of this trial (which will be available in 2015) will provide important clinical evidence for the effect of acupuncture on serum metabolites and demonstrate how acupuncture can be helpful for the treatment of obesity.
  
  
  BACKGROUND
  Trial registration registered via US National Institutes of Health Clinical Trials registry (ClinicalTrials.gov) on 11 November 2014, identifier: NCT02066090 .
authors.affiliation: Department of Korean Rehabilitation Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. garson83@hanmail.net.
authors.forename: Koh-Woon
authors.initials: KW
authors.lastname: Kim
authors.affiliation: Institute of Pharmaceutical Science and Technology and College of Pharmacy, Hanyang University, Ansan-si, Gyeonggi-do, 426-791, Republic of Korea. yoohh@ehanyang.ac.kr.
authors.forename: Hye Hyun
authors.initials: HH
authors.lastname: Yoo
authors.affiliation: Department of Korean Rehabilitation Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. vetkong95@hanmail.net.
authors.forename: Jae-Heung
authors.initials: JH
authors.lastname: Cho
authors.affiliation: Department of Korean Rehabilitation Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. ehanabi@hanmail.net.
authors.forename: Yo-Chan
authors.initials: YC
authors.lastname: Yang
authors.affiliation: Department of Korean Rehabilitation Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. nereid1226@naver.com.
authors.forename: Je-In
authors.initials: JI
authors.lastname: Kim
authors.affiliation: Studies of Translational Acupuncture Research, Acupuncture and Meridian Science Research Center, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. cl2300@hanmail.net.
authors.forename: Song-Yi
authors.initials: SY
authors.lastname: Kim
authors.affiliation: Studies of Translational Acupuncture Research, Acupuncture and Meridian Science Research Center, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. serius2000@hanmail.net.
authors.forename: Ji-Yeun
authors.initials: JY
authors.lastname: Park
authors.affiliation: Studies of Translational Acupuncture Research, Acupuncture and Meridian Science Research Center, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. acufind@khu.ac.kr.|Department of Acupoint and Meridian, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. acufind@khu.ac.kr.
authors.forename: Hi-Joon
authors.initials: HJ
authors.lastname: Park
authors.affiliation: Department of Korean Rehabilitation Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. mysong@khu.ac.kr.
authors.forename: Mi-Yeon
authors.initials: MY
authors.lastname: Song
mesh_terms: D015670:Acupuncture Therapy / Q000009:adverse effects; D050154:Adiposity; D000328:Adult; D000367:Age Factors; D000886:Anthropometry; D015415:Biomarkers / Q000097:blood; D015992:Body Mass Index; D002784:Cholesterol / Q000097:blood*; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D055432:Metabolomics / Q000379:methods; D009765:Obesity / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D017697:Premenopause / Q000097:blood*; D056910:Republic of Korea; D012107:Research Design; D012737:Sex Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood*; D055815:Young Adult
chemical_list: D015415:Biomarkers; D014280:Triglycerides; D002784:Cholesterol