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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Muharrem Gökhan Beydağı, PhD
- Telefoonnummer: +905323581105
- E-mail: mgbeydagi@firat.edu.tr
Studie Contact Back-up
- Naam: Murat Acik, PhD
- Telefoonnummer: +90 544 111 81 24
- E-mail: macik@firat.edu.tr
Studie Locaties
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Diyarbakır, Turkije (Türkiye)
- Dicle University
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Contact:
- Feray Cagiran Yilmaz, assistant professor
- E-mail: feraycagiran@hotmail.com
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Elâzığ, Turkije (Türkiye)
- Firat University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in serum irisin levels
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in serum myostatin levels
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- FU_MGBeydagi_EMS_B_2026/05
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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