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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Muharrem Gökhan Beydağı, PhD
- Numéro de téléphone: +905323581105
- E-mail: mgbeydagi@firat.edu.tr
Sauvegarde des contacts de l'étude
- Nom: Murat Acik, PhD
- Numéro de téléphone: +90 544 111 81 24
- E-mail: macik@firat.edu.tr
Lieux d'étude
-
-
-
Diyarbakır, Turquie (Türkiye)
- Dicle University
-
Contact:
- Feray Cagiran Yilmaz, assistant professor
- E-mail: feraycagiran@hotmail.com
-
Elâzığ, Turquie (Türkiye)
- Firat University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Diet Only
Participants receive an individualized energy-restricted diet program.
|
A personalized diet with approximately 750 kcal/day energy deficit.
|
|
Expérimental: Diet + WB-EMS
Participants receive an energy-restricted diet combined with whole-body electromyostimulation (WB-EMS).
|
A personalized diet with approximately 750 kcal/day energy deficit.
Whole-body electromyostimulation applied 2-3 times per week for 8 weeks under supervision.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in serum irisin levels
Délai: Baseline to 8 weeks
|
Assessment of change in circulating irisin levels measured by ELISA.
|
Baseline to 8 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in serum myostatin levels
Délai: Baseline to 8 weeks
|
Assessment of change in circulating myostatin levels measured by ELISA.
|
Baseline to 8 weeks
|
|
Change in serum leptin levels
Délai: Baseline to 8 weeks
|
Assessment of change in circulating leptin levels.
|
Baseline to 8 weeks
|
|
Change in serum adiponectin levels
Délai: Baseline to 8 weeks
|
Assessment of change in circulating adiponectin levels.
|
Baseline to 8 weeks
|
|
Change in serum FGF-21 levels
Délai: Baseline to 8 weeks
|
Assessment of change in circulating fibroblast growth factor-21 levels.
|
Baseline to 8 weeks
|
|
Change in serum ghrelin levels
Délai: Baseline to 8 weeks
|
Assessment of change in circulating ghrelin levels.
|
Baseline to 8 weeks
|
|
Change in serum GLP-1 levels
Délai: Baseline to 8 weeks
|
Assessment of change in circulating GLP-1 levels.
|
Baseline to 8 weeks
|
|
Change in fat mass
Délai: Baseline to 8 weeks
|
Assessment of change in total body fat mass measured by bioelectrical impedance analysis (BIA).
|
Baseline to 8 weeks
|
|
Change in fat-free mass
Délai: Baseline to 8 weeks
|
Assessment of change in fat-free mass measured by bioelectrical impedance analysis (BIA).
|
Baseline to 8 weeks
|
|
Change in body fat percentage
Délai: Baseline to 8 weeks
|
Assessment of change in body fat percentage measured by bioelectrical impedance analysis (BIA).
|
Baseline to 8 weeks
|
|
Change in eating behavior scores
Délai: Baseline to 8 weeks
|
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.
|
Baseline to 8 weeks
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FU_MGBeydagi_EMS_B_2026/05
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .