- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07675382
WB-EMS and Diet Effects on Body Composition, Cardiometabolic Markers, and Myokines in Obese Women
Effects of an Eight-Week Whole-Body Electromyostimulation and Diet Program on Body Composition, Cardiometabolic Markers, and the Myokines Irisin and Betatrophin in Women With Obesity: A Randomized Controlled Trial
연구 개요
상세 설명
This study was a randomized controlled trial (RCT) designed to investigate the effects of an 8-week whole-body electromyostimulation (WB-EMS) combined with a hypocaloric diet on body composition, cardiometabolic markers, and serum levels of the myokines irisin and betatrophin (ANGPTL8) in women with obesity.
Participants were randomly assigned to one of two groups: (1) Diet-only group (control): received a hypocaloric diet prescription without exercise training; (2) WB-EMS + Diet group (intervention): received the same hypocaloric diet plus WB-EMS training sessions conducted twice weekly (20-25 minutes per session) over 8 weeks.
Body composition assessments included body weight, BMI, body fat percentage, fat mass, fat-free mass, and waist circumference, measured using multifrequency bioelectrical impedance analysis (InBody 270). Cardiometabolic markers assessed included fasting blood glucose, serum insulin, HOMA-IR, HbA1c, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, blood pressure, and C-reactive protein (CRP). Serum irisin and betatrophin concentrations were measured at baseline and post-intervention using ELISA.
The primary aim was to evaluate whether WB-EMS combined with dietary restriction provides additional metabolic and myokine-related benefits beyond those achieved by dietary restriction alone in obese women.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Elâzığ, 터키 (Türkiye)
- Firat University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adult women aged 18-65 years
- BMI >= 30 kg/m2 (obesity)
- Sedentary lifestyle (no regular physical activity for the past 6 months)
- Willingness to participate and provide written informed consent
Exclusion Criteria:
- Pregnancy or breastfeeding
- Cardiovascular disease, neurological disorders, or implanted pacemaker/defibrillator
- Active cancer or ongoing chemotherapy/radiotherapy
- Use of medications affecting body weight or metabolic parameters
- Prior WB-EMS training experience
- Skin conditions contraindicating electrode use
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Diet Only
Participants received an 8-week individualized hypocaloric diet program only.
The diet was prescribed based on the Mifflin-St.
Jeor equation with a 500 kcal/day deficit.
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An individualized hypocaloric diet with a 500 kcal/day deficit calculated using the Mifflin-St.
Jeor equation, prescribed to both study arms for 8 weeks.
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실험적: Diet + WB-EMS
Participants received an 8-week individualized hypocaloric diet program combined with whole-body electromyostimulation (WB-EMS) training.
The diet was prescribed based on the Mifflin-St.
Jeor equation with a 500 kcal/day deficit.
WB-EMS sessions were performed twice per week for 20 minutes using a full-body electrostimulation suit.
|
An individualized hypocaloric diet with a 500 kcal/day deficit calculated using the Mifflin-St.
Jeor equation, prescribed to both study arms for 8 weeks.
WB-EMS training was performed twice per week for 8 weeks, with 20-minute sessions using a full-body electrostimulation suit.
Stimulation parameters: frequency 85 Hz, pulse width 350 µs, intermittent mode (4 s on / 4 s off), with simultaneous dynamic exercises.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Body Weight
기간: 8 weeks (baseline to post-intervention)
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Changes in body weight (kg) measured by multifrequency bioelectrical impedance analyser (InBody 270) from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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Body Mass Index (BMI)
기간: 8 weeks (baseline to post-intervention)
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Changes in body mass index (BMI, kg/m²) measured by multifrequency bioelectrical impedance analyser (InBody 270) from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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Body Fat Percentage
기간: 8 weeks (baseline to post-intervention)
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Changes in body fat percentage (%) measured by multifrequency bioelectrical impedance analyser (InBody 270) from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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Fat Mass
기간: 8 weeks (baseline to post-intervention)
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Changes in fat mass (kg) measured by multifrequency bioelectrical impedance analyser (InBody 270) from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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Fat-Free Mass (Lean Body Mass)
기간: 8 weeks (baseline to post-intervention)
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Changes in fat-free mass / lean body mass (kg) measured by multifrequency bioelectrical impedance analyser (InBody 270) from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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Waist Circumference
기간: 8 weeks (baseline to post-intervention)
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Changes in waist circumference (cm) measured by standard anthropometric tape from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fasting Blood Glucose (FBG)
기간: 8 weeks (baseline to post-intervention)
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Changes in fasting blood glucose (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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Serum Insulin
기간: 8 weeks (baseline to post-intervention)
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Changes in serum insulin (µIU/mL) measured by immunoassay platform from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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HOMA-IR (Insulin Resistance)
기간: 8 weeks (baseline to post-intervention)
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Changes in HOMA-IR (calculated as fasting insulin x fasting glucose / 405) from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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Glycated Haemoglobin (HbA1c)
기간: 8 weeks (baseline to post-intervention)
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Changes in HbA1c (%) measured by immunoassay platform from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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Total Cholesterol (TC)
기간: 8 weeks (baseline to post-intervention)
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Changes in total cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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Triglycerides (TG)
기간: 8 weeks (baseline to post-intervention)
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Changes in serum triglycerides (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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LDL Cholesterol (LDL-C)
기간: 8 weeks (baseline to post-intervention)
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Changes in LDL cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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HDL Cholesterol (HDL-C)
기간: 8 weeks (baseline to post-intervention)
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Changes in HDL cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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C-Reactive Protein (CRP)
기간: 8 weeks (baseline to post-intervention)
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Changes in serum C-reactive protein (mg/L) measured by high-sensitivity immunoassay from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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Serum Irisin
기간: 8 weeks (baseline to post-intervention)
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Changes in serum irisin levels (ng/mL) measured by ELISA from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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Serum Betatrophin (ANGPTL8)
기간: 8 weeks (baseline to post-intervention)
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Changes in serum betatrophin (ANGPTL8) levels (ng/mL) measured by ELISA from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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Systolic Blood Pressure
기간: 8 weeks (baseline to post-intervention)
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Changes in systolic blood pressure (mmHg) measured by sphygmomanometer after 10 minutes of rest from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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Diastolic Blood Pressure
기간: 8 weeks (baseline to post-intervention)
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Changes in diastolic blood pressure (mmHg) measured by sphygmomanometer after 10 minutes of rest from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
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공동 작업자 및 조사자
스폰서
협력자
수사관
- 연구 책임자: Fazilet Erman, Dr, Firat University
- 연구 책임자: Feray Cagiran Yilmaz, Dr, Dicle University
- 연구 책임자: Esra Das, Msc, Firat University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- FU_MAcik_WB-EMS_2025
- 30456 (기타 식별자: Firat Univ. Non-Interventional Research Ethics Comm.)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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