Diet and WB-EMS Effects in Obesity (DEMO-OB)
Effects of Energy-Restricted Diet and Whole-Body Electromyostimulation (WB-EMS) on Myokine-Adipokine Interaction, Appetite Regulation, and Body Composition in Obese Individuals: A Randomized Controlled Trial
Obesity is a major global health problem associated with metabolic dysfunction, altered adipokine signaling, and impaired appetite regulation. Conventional weight loss strategies such as calorie restriction often result in compensatory physiological adaptations, including increased appetite and loss of lean body mass, which may limit long-term effectiveness.
Whole-body electromyostimulation (WB-EMS) is an emerging, time-efficient intervention that induces simultaneous muscle activation and may improve metabolic health. However, the underlying molecular mechanisms, particularly the interaction between myokines and adipokines, remain insufficiently understood.
This randomized controlled trial aims to investigate the effects of an energy-restricted diet combined with WB-EMS on myokine-adipokine interaction, appetite regulation, and body composition in obese individuals. Participants will be randomly assigned to either a diet-only group or a diet plus WB-EMS group for 8 weeks.
Primary outcomes include changes in serum irisin levels. Secondary outcomes include myostatin, leptin, adiponectin, FGF-21, ghrelin, GLP-1, body composition parameters, and eating behavior. The findings of this study are expected to provide novel insights into the physiological and molecular effects of WB-EMS as a complementary strategy in obesity management.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Muharrem Gökhan Beydağı, PhD
- 전화번호: +905323581105
- 이메일: mgbeydagi@firat.edu.tr
연구 연락처 백업
- 이름: Murat Acik, PhD
- 전화번호: +90 544 111 81 24
- 이메일: macik@firat.edu.tr
연구 장소
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Diyarbakır, 터키 (Türkiye)
- Dicle University
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연락하다:
- Feray Cagiran Yilmaz, assistant professor
- 이메일: feraycagiran@hotmail.com
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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:
- Age between 18 and 65 years
- Body mass index (BMI) ≥ 30 kg/m²
- Sedentary lifestyle (less than 2 hours of structured exercise per week)
- Willingness to participate and provide written informed consent
Exclusion Criteria:
- Presence of pacemaker or implantable cardioverter-defibrillator
- Known cardiovascular disease or severe chronic illness
- Pregnancy or breastfeeding
- Uncontrolled diabetes or severe metabolic disorders
- Active malignancy or cancer treatment
- Severe renal or hepatic failure
- Acute infection or inflammatory disease
- Orthopedic conditions limiting physical activity
- Use of medications affecting body composition or appetite (e.g., corticosteroids, weight-loss drugs)
- Regular resistance training within the last 3 months
- Substance abuse, including alcohol or drug dependency
- Psychiatric or cognitive conditions affecting adherence to the study protocol
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Diet Only
Participants receive an individualized energy-restricted diet program.
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A personalized diet with approximately 750 kcal/day energy deficit.
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실험적: Diet + WB-EMS
Participants receive an energy-restricted diet combined with whole-body electromyostimulation (WB-EMS).
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A personalized diet with approximately 750 kcal/day energy deficit.
Whole-body electromyostimulation applied 2-3 times per week for 8 weeks under supervision.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in serum irisin levels
기간: Baseline to 8 weeks
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Assessment of change in circulating irisin levels measured by ELISA.
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Baseline to 8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in serum myostatin levels
기간: Baseline to 8 weeks
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Assessment of change in circulating myostatin levels measured by ELISA.
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Baseline to 8 weeks
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Change in serum leptin levels
기간: Baseline to 8 weeks
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Assessment of change in circulating leptin levels.
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Baseline to 8 weeks
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Change in serum adiponectin levels
기간: Baseline to 8 weeks
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Assessment of change in circulating adiponectin levels.
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Baseline to 8 weeks
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Change in serum FGF-21 levels
기간: Baseline to 8 weeks
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Assessment of change in circulating fibroblast growth factor-21 levels.
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Baseline to 8 weeks
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Change in serum ghrelin levels
기간: Baseline to 8 weeks
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Assessment of change in circulating ghrelin levels.
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Baseline to 8 weeks
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Change in serum GLP-1 levels
기간: Baseline to 8 weeks
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Assessment of change in circulating GLP-1 levels.
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Baseline to 8 weeks
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Change in fat mass
기간: Baseline to 8 weeks
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Assessment of change in total body fat mass measured by bioelectrical impedance analysis (BIA).
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Baseline to 8 weeks
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Change in fat-free mass
기간: Baseline to 8 weeks
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Assessment of change in fat-free mass measured by bioelectrical impedance analysis (BIA).
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Baseline to 8 weeks
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Change in body fat percentage
기간: Baseline to 8 weeks
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Assessment of change in body fat percentage measured by bioelectrical impedance analysis (BIA).
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Baseline to 8 weeks
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Change in eating behavior scores
기간: Baseline to 8 weeks
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Assessment of eating behavior using the Three-Factor Eating Questionnaire-Revised 21 (TFEQ-R21).
The questionnaire evaluates cognitive restraint, uncontrolled eating, and emotional eating behaviors.
Scores range from 21 to 84, with higher scores indicating more problematic eating behaviors.
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Baseline to 8 weeks
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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_MGBeydagi_EMS_B_2026/05
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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