- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07675382
WB-EMS and Diet Effects on Body Composition, Cardiometabolic Markers, and Myokines in Obese Women
Effects of an Eight-Week Whole-Body Electromyostimulation and Diet Program on Body Composition, Cardiometabolic Markers, and the Myokines Irisin and Betatrophin in Women With Obesity: A Randomized Controlled Trial
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
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Elâzığ, Turcja (Türkiye)
- Firat University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Adult women aged 18-65 years
- BMI >= 30 kg/m2 (obesity)
- Sedentary lifestyle (no regular physical activity for the past 6 months)
- Willingness to participate and provide written informed consent
Exclusion Criteria:
- Pregnancy or breastfeeding
- Cardiovascular disease, neurological disorders, or implanted pacemaker/defibrillator
- Active cancer or ongoing chemotherapy/radiotherapy
- Use of medications affecting body weight or metabolic parameters
- Prior WB-EMS training experience
- Skin conditions contraindicating electrode use
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: Diet Only
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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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.
|
|
Eksperymentalny: Diet + WB-EMS
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.
|
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.
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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Body Weight
Ramy czasowe: 8 weeks (baseline to post-intervention)
|
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)
|
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Body Mass Index (BMI)
Ramy czasowe: 8 weeks (baseline to post-intervention)
|
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)
|
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Body Fat Percentage
Ramy czasowe: 8 weeks (baseline to post-intervention)
|
Changes in body fat percentage (%) measured by multifrequency bioelectrical impedance analyser (InBody 270) from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
|
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Fat Mass
Ramy czasowe: 8 weeks (baseline to post-intervention)
|
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)
Ramy czasowe: 8 weeks (baseline to post-intervention)
|
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)
|
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Waist Circumference
Ramy czasowe: 8 weeks (baseline to post-intervention)
|
Changes in waist circumference (cm) measured by standard anthropometric tape from baseline to post-intervention (8 weeks).
|
8 weeks (baseline to post-intervention)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Fasting Blood Glucose (FBG)
Ramy czasowe: 8 weeks (baseline to post-intervention)
|
Changes in fasting blood glucose (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
|
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Serum Insulin
Ramy czasowe: 8 weeks (baseline to post-intervention)
|
Changes in serum insulin (µIU/mL) measured by immunoassay platform from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
|
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HOMA-IR (Insulin Resistance)
Ramy czasowe: 8 weeks (baseline to post-intervention)
|
Changes in HOMA-IR (calculated as fasting insulin x fasting glucose / 405) from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
|
|
Glycated Haemoglobin (HbA1c)
Ramy czasowe: 8 weeks (baseline to post-intervention)
|
Changes in HbA1c (%) measured by immunoassay platform from baseline to post-intervention (8 weeks).
|
8 weeks (baseline to post-intervention)
|
|
Total Cholesterol (TC)
Ramy czasowe: 8 weeks (baseline to post-intervention)
|
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)
Ramy czasowe: 8 weeks (baseline to post-intervention)
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Changes in serum triglycerides (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
|
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LDL Cholesterol (LDL-C)
Ramy czasowe: 8 weeks (baseline to post-intervention)
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Changes in LDL cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
|
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HDL Cholesterol (HDL-C)
Ramy czasowe: 8 weeks (baseline to post-intervention)
|
Changes in HDL cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
|
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C-Reactive Protein (CRP)
Ramy czasowe: 8 weeks (baseline to post-intervention)
|
Changes in serum C-reactive protein (mg/L) measured by high-sensitivity immunoassay from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
|
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Serum Irisin
Ramy czasowe: 8 weeks (baseline to post-intervention)
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Changes in serum irisin levels (ng/mL) measured by ELISA from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
|
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Serum Betatrophin (ANGPTL8)
Ramy czasowe: 8 weeks (baseline to post-intervention)
|
Changes in serum betatrophin (ANGPTL8) levels (ng/mL) measured by ELISA from baseline to post-intervention (8 weeks).
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8 weeks (baseline to post-intervention)
|
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Systolic Blood Pressure
Ramy czasowe: 8 weeks (baseline to post-intervention)
|
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)
|
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Diastolic Blood Pressure
Ramy czasowe: 8 weeks (baseline to post-intervention)
|
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)
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Dyrektor Studium: Fazilet Erman, Dr, Firat University
- Dyrektor Studium: Feray Cagiran Yilmaz, Dr, Dicle University
- Dyrektor Studium: Esra Das, Msc, Firat University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- FU_MAcik_WB-EMS_2025
- 30456 (Inny identyfikator: Firat Univ. Non-Interventional Research Ethics Comm.)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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