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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Muharrem Gökhan Beydağı, PhD
- Telefonnummer: +905323581105
- E-post: mgbeydagi@firat.edu.tr
Studer Kontakt Backup
- Navn: Murat Acik, PhD
- Telefonnummer: +90 544 111 81 24
- E-post: macik@firat.edu.tr
Studiesteder
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Diyarbakır, Tyrkia (Türkiye)
- Dicle University
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Ta kontakt med:
- Feray Cagiran Yilmaz, assistant professor
- E-post: feraycagiran@hotmail.com
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Elâzığ, Tyrkia (Türkiye)
- Firat University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in serum irisin levels
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in serum myostatin levels
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FU_MGBeydagi_EMS_B_2026/05
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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