Diet and WB-EMS Effects in Obesity

NCT07562724 | Not Yet Recruiting

• 1 other identifier: FU_MGBeydagi_EMS_B_2026/05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Obesity & Overweight; Metabolic Disorders; Electrotherapy

Outcome Measures

Primary Outcomes (1)

• Change in serum irisin levels

  Assessment of change in circulating irisin levels measured by ELISA.

  Baseline to 8 weeks

Secondary Outcomes (8)

• Change in serum myostatin levels

  Baseline to 8 weeks

• Change in serum leptin levels

  Baseline to 8 weeks

• Change in serum adiponectin levels

  Baseline to 8 weeks

• Change in serum FGF-21 levels

  Baseline to 8 weeks

• Change in serum ghrelin levels

  Baseline to 8 weeks

Study Arms (2)

Diet Only

ACTIVE COMPARATOR

Participants receive an individualized energy-restricted diet program.

Behavioral: Energy-Restricted Diet

Diet + WB-EMS

EXPERIMENTAL

Participants receive an energy-restricted diet combined with whole-body electromyostimulation (WB-EMS).

Behavioral: Energy-Restricted Diet; Device: Whole-Body Electromyostimulation (WB-EMS)

Interventions

Energy-Restricted Diet BEHAVIORAL

A personalized diet with approximately 750 kcal/day energy deficit.

Diet + WB-EMS; Diet Only

Whole-Body Electromyostimulation (WB-EMS) DEVICE

Whole-body electromyostimulation applied 2-3 times per week for 8 weeks under supervision.

Diet + WB-EMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Firat University: lead

Study Sites (2)

Dicle University

Diyarbakır, Turkey (Türkiye)

Location

Firat University

Elâzığ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity; Overweight; Metabolic Diseases

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Murat Acik, PhD

CONTACT

+90 544 111 81 24; macik@firat.edu.tr

Muharrem Gökhan Beydağı, PhD

CONTACT

+905323581105; mgbeydagi@firat.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Model Details: Participants will be randomly assigned in a 1:1 ratio to either an energy-restricted diet group or an energy-restricted diet plus whole-body electromyostimulation (WB-EMS) group. The study will follow a parallel-group design with two intervention arms over an 8-week period.

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): June 20, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)