Obesity & OverweightDEMO-OBNCT07562724
Diet and WB-EMS Effects in Obesity
A study testing Energy-Restricted Diet and Whole-Body Electromyostimulation (WB-EMS) in people with Obesity & Overweight and Metabolic Disorders, run by Firat University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity & Overweight, Metabolic Disorders, Electrotherapy
- What is being tested?
- Energy-Restricted Diet and Whole-Body Electromyostimulation (WB-EMS)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 20 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Dicle University
Diyarbakır
Feray Cagiran Yilmaz, assistant professor, feraycagiran@hotmail.com
Firat University
Elâzığ
About this study
Official 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
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.
Read more
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
- Being tested
- Energy-Restricted Diet, Whole-Body Electromyostimulation (WB-EMS)
- Medical subject headings
- Obesity, Overweight, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy-Restricted DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Diet Only | Active comparator | Participants receive an individualized energy-restricted diet program. Receives: Behavioral: Energy-Restricted Diet |
| Diet + WB-EMS | Experimental | Participants receive an energy-restricted diet combined with whole-body electromyostimulation (WB-EMS). Receives: Behavioral: Energy-Restricted Diet; Device: Whole-Body Electromyostimulation (WB-EMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum irisin levels
Assessment of change in circulating irisin levels measured by ELISA.
Measured: Baseline to 8 weeks
Secondary outcomes (10)
Change in serum myostatin levels
Assessment of change in circulating myostatin levels measured by ELISA.
Measured: Baseline to 8 weeks
Change in serum leptin levels
Assessment of change in circulating leptin levels.
Measured: Baseline to 8 weeks
Change in serum adiponectin levels
Assessment of change in circulating adiponectin levels.
Measured: Baseline to 8 weeks
Change in serum FGF-21 levels
Assessment of change in circulating fibroblast growth factor-21 levels.
Measured: Baseline to 8 weeks
Change in serum ghrelin levels
Assessment of change in circulating ghrelin levels.
Measured: Baseline to 8 weeks
Change in serum GLP-1 levels
Assessment of change in circulating GLP-1 levels.
Measured: Baseline to 8 weeks
Change in fat mass
Assessment of change in total body fat mass measured by bioelectrical impedance analysis (BIA).
Measured: Baseline to 8 weeks
Change in fat-free mass
Assessment of change in fat-free mass measured by bioelectrical impedance analysis (BIA).
Measured: Baseline to 8 weeks
Change in body fat percentage
Assessment of change in body fat percentage measured by bioelectrical impedance analysis (BIA).
Measured: Baseline to 8 weeks
Change in eating behavior scores
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.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Açık, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562724
- Sponsor's protocol ID
- FU_MGBeydagi_EMS_B_2026/05
- Acronym
- DEMO-OB
- Status last verified
- May 2026
- First submitted
- 26 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07562724
- Acronym / sponsor ID
- DEMO-OB / FU_MGBeydagi_EMS_B_2026/05
- Conditions
- Obesity & Overweight, Metabolic Disorders, Electrotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diet Only | Active comparator | Behavioral: Energy-Restricted DietParticipants receive an individualized energy-restricted diet program. |
| Diet + WB-EMS | Experimental | Behavioral: Energy-Restricted Diet, Device: Whole-Body Electromyostimulation (WB-EMS)Participants receive an energy-restricted diet combined with whole-body electromyostimulation (WB-EMS). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy-Restricted DietA personalized diet with approximately 750 kcal/day energy deficit. | Behavioural | Diet + WB-EMS, Diet Only |
| Whole-Body Electromyostimulation (WB-EMS)Whole-body electromyostimulation applied 2-3 times per week for 8 weeks under supervision. | Device | Diet + WB-EMS |
Primary outcome
Change in serum irisin levels
Time frame: Baseline to 8 weeks
Assessment of change in circulating irisin levels measured by ELISA.
10 secondary outcomes
Change in serum myostatin levels
Time frame: Baseline to 8 weeks
Change in serum leptin levels
Time frame: Baseline to 8 weeks
Change in serum adiponectin levels
Time frame: Baseline to 8 weeks
Change in serum FGF-21 levels
Time frame: Baseline to 8 weeks
Change in serum ghrelin levels
Time frame: Baseline to 8 weeks
Change in serum GLP-1 levels
Time frame: Baseline to 8 weeks
Change in fat mass
Time frame: Baseline to 8 weeks
Change in fat-free mass
Time frame: Baseline to 8 weeks
Change in body fat percentage
Time frame: Baseline to 8 weeks
Change in eating behavior scores
Time frame: Baseline to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Obesity & Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy-Restricted Diet and Whole-Body Electromyostimulation (WB-EMS) in people with Obesity & Overweight and Metabolic Disorders, run by Firat University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Murat Acik, PhD (+90 544 111 81 24, macik@firat.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum irisin levels (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.