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WB-EMS and Diet Effects on Body Composition, Cardiometabolic Markers, and Myokines in Obese Women

26 de junio de 2026 actualizado por: Murat Açık, Firat University

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

This randomized controlled trial investigated 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 either a diet-only group or a diet plus WB-EMS group. WB-EMS sessions were conducted twice weekly (20-25 minutes per session) over 8 weeks. The primary outcomes included BMI, body fat percentage, lean body mass, fasting blood glucose, insulin, HOMA-IR, HbA1c, lipid profile, CRP, and serum irisin and betatrophin concentrations. The study aimed to evaluate whether WB-EMS adds metabolic and myokine-related benefits beyond those achieved by dietary restriction alone in obese women.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

44

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.
Conductual: Hypocaloric Diet
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.
Experimental: 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.
Conductual: Hypocaloric Diet
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.
Dispositivo: Whole-Body Electromyostimulation (WB-EMS)
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Body Weight
Periodo de tiempo: 8 weeks (baseline to post-intervention)
Changes in body weight (kg) measured by multifrequency bioelectrical impedance analyser (InBody 270) from baseline to post-intervention (8 weeks).
8 weeks (baseline to post-intervention)
Body Mass Index (BMI)
Periodo de tiempo: 8 weeks (baseline to post-intervention)
Changes in body mass index (BMI, kg/m²) measured by multifrequency bioelectrical impedance analyser (InBody 270) from baseline to post-intervention (8 weeks).
8 weeks (baseline to post-intervention)
Body Fat Percentage
Periodo de tiempo: 8 weeks (baseline to post-intervention)
Changes in body fat percentage (%) measured by multifrequency bioelectrical impedance analyser (InBody 270) from baseline to post-intervention (8 weeks).
8 weeks (baseline to post-intervention)
Fat Mass
Periodo de tiempo: 8 weeks (baseline to post-intervention)
Changes in fat mass (kg) measured by multifrequency bioelectrical impedance analyser (InBody 270) from baseline to post-intervention (8 weeks).
8 weeks (baseline to post-intervention)
Fat-Free Mass (Lean Body Mass)
Periodo de tiempo: 8 weeks (baseline to post-intervention)
Changes in fat-free mass / lean body mass (kg) measured by multifrequency bioelectrical impedance analyser (InBody 270) from baseline to post-intervention (8 weeks).
8 weeks (baseline to post-intervention)
Waist Circumference
Periodo de tiempo: 8 weeks (baseline to post-intervention)
Changes in waist circumference (cm) measured by standard anthropometric tape from baseline to post-intervention (8 weeks).
8 weeks (baseline to post-intervention)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Fasting Blood Glucose (FBG)
Periodo de tiempo: 8 weeks (baseline to post-intervention)
Changes in fasting blood glucose (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks).
8 weeks (baseline to post-intervention)
Serum Insulin
Periodo de tiempo: 8 weeks (baseline to post-intervention)
Changes in serum insulin (µIU/mL) measured by immunoassay platform from baseline to post-intervention (8 weeks).
8 weeks (baseline to post-intervention)
HOMA-IR (Insulin Resistance)
Periodo de tiempo: 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).
8 weeks (baseline to post-intervention)
Glycated Haemoglobin (HbA1c)
Periodo de tiempo: 8 weeks (baseline to post-intervention)
Changes in HbA1c (%) measured by immunoassay platform from baseline to post-intervention (8 weeks).
8 weeks (baseline to post-intervention)
Total Cholesterol (TC)
Periodo de tiempo: 8 weeks (baseline to post-intervention)
Changes in total cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks).
8 weeks (baseline to post-intervention)
Triglycerides (TG)
Periodo de tiempo: 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).
8 weeks (baseline to post-intervention)
LDL Cholesterol (LDL-C)
Periodo de tiempo: 8 weeks (baseline to post-intervention)
Changes in LDL cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks).
8 weeks (baseline to post-intervention)
HDL Cholesterol (HDL-C)
Periodo de tiempo: 8 weeks (baseline to post-intervention)
Changes in HDL cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks).
8 weeks (baseline to post-intervention)
C-Reactive Protein (CRP)
Periodo de tiempo: 8 weeks (baseline to post-intervention)
Changes in serum C-reactive protein (mg/L) measured by high-sensitivity immunoassay from baseline to post-intervention (8 weeks).
8 weeks (baseline to post-intervention)
Serum Irisin
Periodo de tiempo: 8 weeks (baseline to post-intervention)
Changes in serum irisin levels (ng/mL) measured by ELISA from baseline to post-intervention (8 weeks).
8 weeks (baseline to post-intervention)
Serum Betatrophin (ANGPTL8)
Periodo de tiempo: 8 weeks (baseline to post-intervention)
Changes in serum betatrophin (ANGPTL8) levels (ng/mL) measured by ELISA from baseline to post-intervention (8 weeks).
8 weeks (baseline to post-intervention)
Systolic Blood Pressure
Periodo de tiempo: 8 weeks (baseline to post-intervention)
Changes in systolic blood pressure (mmHg) measured by sphygmomanometer after 10 minutes of rest from baseline to post-intervention (8 weeks).
8 weeks (baseline to post-intervention)
Diastolic Blood Pressure
Periodo de tiempo: 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).
8 weeks (baseline to post-intervention)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Firat University

Colaboradores

Dicle University

Investigadores

  • Director de estudio: Fazilet Erman, Dr, Firat University
  • Director de estudio: Feray Cagiran Yilmaz, Dr, Dicle University
  • Director de estudio: Esra Das, Msc, Firat University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de mayo de 2025

Finalización primaria (Actual)

1 de marzo de 2026

Finalización del estudio (Actual)

1 de marzo de 2026

Fechas de registro del estudio

Enviado por primera vez

17 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de junio de 2026

Publicado por primera vez (Actual)

30 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • FU_MAcik_WB-EMS_2025
  • 30456 (Otro identificador: Firat Univ. Non-Interventional Research Ethics Comm.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be publicly shared due to institutional privacy policies.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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