Diet and WB-EMS Effects in Obesity (DEMO-OB)

May 11, 2026 updated by: Murat Açık, Firat University

Effects of Energy-Restricted Diet and Whole-Body Electromyostimulation (WB-EMS) on Myokine-Adipokine Interaction, Appetite Regulation, and Body Composition in Obese Individuals: A Randomized Controlled Trial

Obesity is a major global health problem associated with metabolic dysfunction, altered adipokine signaling, and impaired appetite regulation. Conventional weight loss strategies such as calorie restriction often result in compensatory physiological adaptations, including increased appetite and loss of lean body mass, which may limit long-term effectiveness.

Whole-body electromyostimulation (WB-EMS) is an emerging, time-efficient intervention that induces simultaneous muscle activation and may improve metabolic health. However, the underlying molecular mechanisms, particularly the interaction between myokines and adipokines, remain insufficiently understood.

This randomized controlled trial aims to investigate the effects of an energy-restricted diet combined with WB-EMS on myokine-adipokine interaction, appetite regulation, and body composition in obese individuals. Participants will be randomly assigned to either a diet-only group or a diet plus WB-EMS group for 8 weeks.

Primary outcomes include changes in serum irisin levels. Secondary outcomes include myostatin, leptin, adiponectin, FGF-21, ghrelin, GLP-1, body composition parameters, and eating behavior. The findings of this study are expected to provide novel insights into the physiological and molecular effects of WB-EMS as a complementary strategy in obesity management.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 65 years
  • Body mass index (BMI) ≥ 30 kg/m²
  • Sedentary lifestyle (less than 2 hours of structured exercise per week)
  • Willingness to participate and provide written informed consent

Exclusion Criteria:

  • Presence of pacemaker or implantable cardioverter-defibrillator
  • Known cardiovascular disease or severe chronic illness
  • Pregnancy or breastfeeding
  • Uncontrolled diabetes or severe metabolic disorders
  • Active malignancy or cancer treatment
  • Severe renal or hepatic failure
  • Acute infection or inflammatory disease
  • Orthopedic conditions limiting physical activity
  • Use of medications affecting body composition or appetite (e.g., corticosteroids, weight-loss drugs)
  • Regular resistance training within the last 3 months
  • Substance abuse, including alcohol or drug dependency
  • Psychiatric or cognitive conditions affecting adherence to the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diet Only
Participants receive an individualized energy-restricted diet program.
Behavioral: Energy-Restricted Diet
A personalized diet with approximately 750 kcal/day energy deficit.
Experimental: Diet + WB-EMS
Participants receive an energy-restricted diet combined with whole-body electromyostimulation (WB-EMS).
Behavioral: Energy-Restricted Diet
A personalized diet with approximately 750 kcal/day energy deficit.
Device: Whole-Body Electromyostimulation (WB-EMS)
Whole-body electromyostimulation applied 2-3 times per week for 8 weeks under supervision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum irisin levels
Time Frame: Baseline to 8 weeks
Assessment of change in circulating irisin levels measured by ELISA.
Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum myostatin levels
Time Frame: Baseline to 8 weeks
Assessment of change in circulating myostatin levels measured by ELISA.
Baseline to 8 weeks
Change in serum leptin levels
Time Frame: Baseline to 8 weeks
Assessment of change in circulating leptin levels.
Baseline to 8 weeks
Change in serum adiponectin levels
Time Frame: Baseline to 8 weeks
Assessment of change in circulating adiponectin levels.
Baseline to 8 weeks
Change in serum FGF-21 levels
Time Frame: Baseline to 8 weeks
Assessment of change in circulating fibroblast growth factor-21 levels.
Baseline to 8 weeks
Change in serum ghrelin levels
Time Frame: Baseline to 8 weeks
Assessment of change in circulating ghrelin levels.
Baseline to 8 weeks
Change in serum GLP-1 levels
Time Frame: Baseline to 8 weeks
Assessment of change in circulating GLP-1 levels.
Baseline to 8 weeks
Change in fat mass
Time Frame: Baseline to 8 weeks
Assessment of change in total body fat mass measured by bioelectrical impedance analysis (BIA).
Baseline to 8 weeks
Change in fat-free mass
Time Frame: Baseline to 8 weeks
Assessment of change in fat-free mass measured by bioelectrical impedance analysis (BIA).
Baseline to 8 weeks
Change in body fat percentage
Time Frame: Baseline to 8 weeks
Assessment of change in body fat percentage measured by bioelectrical impedance analysis (BIA).
Baseline to 8 weeks
Change in eating behavior scores
Time Frame: Baseline to 8 weeks
Assessment of eating behavior using the Three-Factor Eating Questionnaire-Revised 21 (TFEQ-R21). The questionnaire evaluates cognitive restraint, uncontrolled eating, and emotional eating behaviors. Scores range from 21 to 84, with higher scores indicating more problematic eating behaviors.
Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 20, 2027

Study Completion (Estimated)

June 20, 2027

Study Registration Dates

First Submitted

April 26, 2026

First Submitted That Met QC Criteria

April 26, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FU_MGBeydagi_EMS_B_2026/05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy, ethical, and data protection considerations. The dataset contains sensitive clinical and biochemical information, and sharing is restricted to ensure participant confidentiality in accordance with institutional policies and applicable regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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