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NCT Number: NCT07562724

Diet and WB-EMS Effects in Obesity

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dicle University, Diyarbakır, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Energy-Restricted Diet

Behavioral

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

Whole-Body Electromyostimulation (WB-EMS)

Device

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

Primary outcomes

  1. Change in serum irisin levels

    Time frame: Baseline to 8 weeks

    Assessment of change in circulating irisin levels measured by ELISA.

Secondary outcomes

  1. Change in serum myostatin levels

    Time frame: Baseline to 8 weeks

    Assessment of change in circulating myostatin levels measured by ELISA.

  2. Change in serum leptin levels

    Time frame: Baseline to 8 weeks

    Assessment of change in circulating leptin levels.

  3. Change in serum adiponectin levels

    Time frame: Baseline to 8 weeks

    Assessment of change in circulating adiponectin levels.

  4. Change in serum FGF-21 levels

    Time frame: Baseline to 8 weeks

    Assessment of change in circulating fibroblast growth factor-21 levels.

  5. Change in serum ghrelin levels

    Time frame: Baseline to 8 weeks

    Assessment of change in circulating ghrelin levels.

  6. Change in serum GLP-1 levels

    Time frame: Baseline to 8 weeks

    Assessment of change in circulating GLP-1 levels.

  7. Change in fat mass

    Time frame: Baseline to 8 weeks

    Assessment of change in total body fat mass measured by bioelectrical impedance analysis (BIA).

  8. Change in fat-free mass

    Time frame: Baseline to 8 weeks

    Assessment of change in fat-free mass measured by bioelectrical impedance analysis (BIA).

  9. Change in body fat percentage

    Time frame: Baseline to 8 weeks

    Assessment of change in body fat percentage measured by bioelectrical impedance analysis (BIA).

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Muharrem Gökhan Beydağı, PhD

CONTACT

[email protected]

+905323581105

Murat Acik, PhD

CONTACT

[email protected]

+90 544 111 81 24

Sponsors and collaborators

Lead sponsor

Firat University

Other

Registry information

Official study title

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

Acronym: DEMO-OB

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 1, 2026
Registry last updated
May 14, 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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