- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Elâzığ, Tyrkia (Türkiye)
- Firat University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv 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.
|
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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Body Weight
Tidsramme: 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)
|
|
Body Mass Index (BMI)
Tidsramme: 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)
|
|
Body Fat Percentage
Tidsramme: 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).
|
8 weeks (baseline to post-intervention)
|
|
Fat Mass
Tidsramme: 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)
Tidsramme: 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)
|
|
Waist Circumference
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fasting Blood Glucose (FBG)
Tidsramme: 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).
|
8 weeks (baseline to post-intervention)
|
|
Serum Insulin
Tidsramme: 8 weeks (baseline to post-intervention)
|
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)
Tidsramme: 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).
|
8 weeks (baseline to post-intervention)
|
|
Glycated Haemoglobin (HbA1c)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 8 weeks (baseline to post-intervention)
|
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)
Tidsramme: 8 weeks (baseline to post-intervention)
|
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)
Tidsramme: 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).
|
8 weeks (baseline to post-intervention)
|
|
C-Reactive Protein (CRP)
Tidsramme: 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).
|
8 weeks (baseline to post-intervention)
|
|
Serum Irisin
Tidsramme: 8 weeks (baseline to post-intervention)
|
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)
Tidsramme: 8 weeks (baseline to post-intervention)
|
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
Tidsramme: 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)
|
|
Diastolic Blood Pressure
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Fazilet Erman, Dr, Firat University
- Studieleder: Feray Cagiran Yilmaz, Dr, Dicle University
- Studieleder: Esra Das, Msc, Firat University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FU_MAcik_WB-EMS_2025
- 30456 (Annen identifikator: Firat Univ. Non-Interventional Research Ethics Comm.)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .