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Completed

NCT Number: NCT07675382

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Firat University

Elâzığ, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypocaloric diet

Behavioral

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.

Whole-Body Electromyostimulation (WB-EMS)

Device

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

Sponsors and collaborators

Lead sponsor

Firat University

Other

Collaborators

  • Dicle University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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