- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Elâzığ, Turkey (Türkiye)
- Firat University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Weight
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fasting Blood Glucose (FBG)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Fazilet Erman, Dr, Firat University
- Study Director: Feray Cagiran Yilmaz, Dr, Dicle University
- Study Director: Esra Das, Msc, Firat University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FU_MAcik_WB-EMS_2025
- 30456 (Other Identifier: Firat Univ. Non-Interventional Research Ethics Comm.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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