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| ID | Type | Description | Link |
|---|---|---|---|
| 30456 | Other Identifier | Firat Univ. Non-Interventional Research Ethics Comm. |
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| Name | Class |
|---|---|
| Dicle University | OTHER |
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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.
This study was a randomized controlled trial (RCT) designed to investigate 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 one of two groups: (1) Diet-only group (control): received a hypocaloric diet prescription without exercise training; (2) WB-EMS + Diet group (intervention): received the same hypocaloric diet plus WB-EMS training sessions conducted twice weekly (20-25 minutes per session) over 8 weeks.
Body composition assessments included body weight, BMI, body fat percentage, fat mass, fat-free mass, and waist circumference, measured using multifrequency bioelectrical impedance analysis (InBody 270). Cardiometabolic markers assessed included fasting blood glucose, serum insulin, HOMA-IR, HbA1c, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, blood pressure, and C-reactive protein (CRP). Serum irisin and betatrophin concentrations were measured at baseline and post-intervention using ELISA.
The primary aim was to evaluate whether WB-EMS combined with dietary restriction provides additional metabolic and myokine-related benefits beyond those achieved by dietary restriction alone in obese women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypocaloric Diet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Blood Glucose (FBG) | Changes in fasting blood glucose (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks). | 8 weeks (baseline to post-intervention) |
| Serum Insulin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fazilet Erman, Dr | Firat University | Study Director |
| Feray Cagiran Yilmaz, Dr | Dicle University | Study Director |
| Esra Das, Msc | Firat University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Firat University | Elâzığ | Turkey (Türkiye) |
Individual participant data will not be publicly shared due to institutional privacy policies.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Whole-Body Electromyostimulation (WB-EMS) | Device | 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. |
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Changes in serum insulin (µIU/mL) measured by immunoassay platform from baseline to post-intervention (8 weeks).
| 8 weeks (baseline to post-intervention) |
| HOMA-IR (Insulin Resistance) | Changes in HOMA-IR (calculated as fasting insulin x fasting glucose / 405) from baseline to post-intervention (8 weeks). | 8 weeks (baseline to post-intervention) |
| Glycated Haemoglobin (HbA1c) | Changes in HbA1c (%) measured by immunoassay platform from baseline to post-intervention (8 weeks). | 8 weeks (baseline to post-intervention) |
| Total Cholesterol (TC) | Changes in total cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks). | 8 weeks (baseline to post-intervention) |
| Triglycerides (TG) | Changes in serum triglycerides (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks). | 8 weeks (baseline to post-intervention) |
| LDL Cholesterol (LDL-C) | Changes in LDL cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks). | 8 weeks (baseline to post-intervention) |
| HDL Cholesterol (HDL-C) | Changes in HDL cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks). | 8 weeks (baseline to post-intervention) |
| C-Reactive Protein (CRP) | Changes in serum C-reactive protein (mg/L) measured by high-sensitivity immunoassay from baseline to post-intervention (8 weeks). | 8 weeks (baseline to post-intervention) |
| Serum Irisin | Changes in serum irisin levels (ng/mL) measured by ELISA from baseline to post-intervention (8 weeks). | 8 weeks (baseline to post-intervention) |
| Serum Betatrophin (ANGPTL8) | Changes in serum betatrophin (ANGPTL8) levels (ng/mL) measured by ELISA from baseline to post-intervention (8 weeks). | 8 weeks (baseline to post-intervention) |
| Systolic Blood Pressure | Changes in systolic blood pressure (mmHg) measured by sphygmomanometer after 10 minutes of rest from baseline to post-intervention (8 weeks). | 8 weeks (baseline to post-intervention) |
| Diastolic Blood Pressure | Changes in diastolic blood pressure (mmHg) measured by sphygmomanometer after 10 minutes of rest from baseline to post-intervention (8 weeks). | 8 weeks (baseline to post-intervention) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |