- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Elâzığ, Turquia (Türkiye)
- Firat University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Body Weight
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fasting Blood Glucose (FBG)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Fazilet Erman, Dr, Firat University
- Diretor de estudo: Feray Cagiran Yilmaz, Dr, Dicle University
- Diretor de estudo: Esra Das, Msc, Firat University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FU_MAcik_WB-EMS_2025
- 30456 (Outro identificador: Firat Univ. Non-Interventional Research Ethics Comm.)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .