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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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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:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Body Weight
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Fasting Blood Glucose (FBG)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 8 weeks (baseline to post-intervention)
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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)
Tijdsspanne: 8 weeks (baseline to post-intervention)
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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)
Tijdsspanne: 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)
Tijdsspanne: 8 weeks (baseline to post-intervention)
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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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 8 weeks (baseline to post-intervention)
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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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Fazilet Erman, Dr, Firat University
- Studie directeur: Feray Cagiran Yilmaz, Dr, Dicle University
- Studie directeur: Esra Das, Msc, Firat University
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- FU_MAcik_WB-EMS_2025
- 30456 (Andere identificatie: Firat Univ. Non-Interventional Research Ethics Comm.)
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