NCT07675382

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

June 17, 2026

Last Update Submit

June 26, 2026

Conditions

Keywords

Whole-body electromyostimulationIrisinBetatrophin

Outcome Measures

Primary Outcomes (6)

  • Body Weight

    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)

    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

    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

    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)

    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

    Changes in waist circumference (cm) measured by standard anthropometric tape from baseline to post-intervention (8 weeks).

    8 weeks (baseline to post-intervention)

Secondary Outcomes (13)

  • Fasting Blood Glucose (FBG)

    8 weeks (baseline to post-intervention)

  • Serum Insulin

    8 weeks (baseline to post-intervention)

  • HOMA-IR (Insulin Resistance)

    8 weeks (baseline to post-intervention)

  • Glycated Haemoglobin (HbA1c)

    8 weeks (baseline to post-intervention)

  • Total Cholesterol (TC)

    8 weeks (baseline to post-intervention)

  • +8 more secondary outcomes

Study Arms (2)

Diet Only

ACTIVE COMPARATOR

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.

Behavioral: Hypocaloric Diet

Diet + WB-EMS

EXPERIMENTAL

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.

Behavioral: Hypocaloric DietDevice: Whole-Body Electromyostimulation (WB-EMS)

Interventions

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.

Diet + WB-EMSDiet Only

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.

Diet + WB-EMS

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Firat University

Elâzığ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fazilet Erman, Dr

    Firat University

    STUDY DIRECTOR
  • Feray Cagiran Yilmaz, Dr

    Dicle University

    STUDY DIRECTOR
  • Esra Das, Msc

    Firat University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 30, 2026

Study Start

May 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

June 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations