- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Elâzığ, Turquie (Türkiye)
- Firat University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Body Weight
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fasting Blood Glucose (FBG)
Délai: 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
Délai: 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)
Délai: 8 weeks (baseline to post-intervention)
|
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)
Délai: 8 weeks (baseline to post-intervention)
|
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)
Délai: 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)
Délai: 8 weeks (baseline to post-intervention)
|
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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 8 weeks (baseline to post-intervention)
|
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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Fazilet Erman, Dr, Firat University
- Directeur d'études: Feray Cagiran Yilmaz, Dr, Dicle University
- Directeur d'études: Esra Das, Msc, Firat University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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_MAcik_WB-EMS_2025
- 30456 (Autre identifiant: Firat Univ. Non-Interventional Research Ethics Comm.)
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