Obesity
Conditions
Keywords
Neuromuscular electrical stimulation, Irisin, Betatrophin, ANGPTL8, Hypocaloric diet
Brief summary
This randomized controlled trial evaluated whether adding localized neuromuscular electrical stimulation (NMES) to an individualized hypocaloric diet changes serum irisin and betatrophin (ANGPTL8) concentrations, body composition and cardiometabolic markers in women with obesity, compared with the diet alone. Forty-four women aged 18-65 years with a body mass index (BMI) of 30 kg/m2 or more were randomly assigned (1:1) to a diet-only group or a diet plus NMES group. NMES was applied to the abdominal and gluteal muscles twice weekly for six weeks (12 sessions of 20-25 minutes). The primary outcomes were the changes in serum irisin and betatrophin; the secondary outcomes were the changes in body weight, BMI, body fat percentage, fat mass, skeletal muscle mass and cardiometabolic markers, assessed at baseline and at the end of week 6.
Detailed description
Design: single-centre, open-label, parallel-group randomized controlled trial with 1:1 allocation. Randomization was stratified by age (18-35 and 36-65 years) and BMI category (30.0-34.9 and \>=35.0 kg/m2), with a separate computer-generated permuted-block sequence (block size four) for each stratum. Laboratory personnel performing the biochemical analyses and the statistician were blinded to group allocation. Dietary intervention (both groups): an individualized hypocaloric diet for six weeks. Resting energy expenditure was calculated with the Mifflin-St Jeor equation and multiplied by a physical activity coefficient of 1.3; 500 kcal/day was subtracted from the estimated total energy expenditure, with an additional 5-10% restriction when weight loss reached a plateau. The diet provided 40-55% of energy from carbohydrate, 15-20% from protein and 25-30% from fat. Meals were self-prepared, and adherence was monitored by a dietitian through weekly online interviews. NMES (diet plus NMES group): Intelect Advanced Combo electrotherapy unit (Chattanooga, DJO Global, Vista, CA, USA); two channels applied simultaneously to the abdominal (rectus abdominis and external oblique) and gluteal (gluteus maximus) muscles with 9 x 12 cm self-adhesive electrodes positioned by motor-point mapping; symmetric biphasic square-wave current with the frequency modulated between 20 and 85 Hz within each session, phase duration set individually within 200-400 microseconds and a duty cycle of 1:2 (5 s on/10 s off); current intensity increased to the maximum tolerable level producing a strong, visible tetanic contraction without pain; twice weekly for six weeks (12 sessions of 20-25 minutes), supervised by a researcher trained to operate the device. Assessments at baseline and at the end of week 6: body weight and body composition (body fat percentage, fat mass, skeletal muscle mass) by multifrequency bioelectrical impedance analysis (InBody 270); height by stadiometer at baseline; fasting blood glucose, insulin, HOMA-IR, HbA1c, total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol and C-reactive protein; serum irisin and betatrophin (ANGPTL8) by ELISA. Adverse events were monitored before each NMES session and at the weekly follow-up interviews.
Interventions
BEHAVIORALHypocaloric Diet
Individualized hypocaloric diet prescribed to both arms for six weeks: resting energy expenditure calculated with the Mifflin-St Jeor equation and multiplied by a physical activity coefficient of 1.3, minus 500 kcal/day, with an additional 5-10% restriction at a weight-loss plateau; 40-55% carbohydrate, 15-20% protein and 25-30% fat; meals self-prepared; adherence monitored through weekly online interviews with a dietitian.
DEVICENeuromuscular Electrical Stimulation (NMES)
Localized two-channel NMES (Intelect Advanced Combo, Chattanooga, DJO Global) applied to the abdominal and gluteal muscles with 9 x 12 cm self-adhesive electrodes positioned by motor-point mapping; symmetric biphasic square-wave current, frequency modulated between 20 and 85 Hz within each session, phase duration 200-400 microseconds set individually, duty cycle 1:2 (5 s on/10 s off), intensity at the maximum tolerable level producing a visible tetanic contraction without pain; twice weekly for six weeks (12 sessions of 20-25 minutes).
Sponsors
Firat University
Dicle University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18-65 years * Obesity according to World Health Organization criteria (BMI \>= 30 kg/m2) * Sedentary lifestyle (less than two hours of regular exercise per week) * Written informed consent * Mild-to-moderate comorbidities (e.g., hypertension managed by diet or monotherapy) were permitted if participation was deemed medically safe by the investigators
Exclusion criteria
* Implantable cardiac device (e.g., pacemaker or implantable cardioverter-defibrillator) * History of cardiovascular disease * Pregnancy or lactation * Advanced or uncontrolled diabetic complications * End-stage renal or hepatic failure * Active malignancy * Acute infection * Severe orthopaedic conditions precluding physical exercise * Regular resistance training (more than 45 minutes per week) within the preceding three months * Body weight change of 5% or more within the preceding three months * Medications known to alter appetite or body composition (e.g., high-dose glucocorticoids, anti-obesity medications) * Excessive alcohol consumption or substance dependence * Severe psychiatric or cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Irisin Concentration | Baseline and end of week 6 | Serum irisin (ng/mL) measured by enzyme-linked immunosorbent assay (ELISA) in fasting venous blood; change from baseline to the end of the six-week intervention. |
| Change in Serum Betatrophin (ANGPTL8) Concentration | Baseline and end of week 6 | Serum betatrophin/ANGPTL8 (ng/L) measured by enzyme-linked immunosorbent assay (ELISA) in fasting venous blood; change from baseline to the end of the six-week intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Baseline and end of week 6 | Body weight (kg) measured with a multifrequency bioelectrical impedance analyser (InBody 270) after an overnight fast; change from baseline to the end of the six-week intervention. |
| Change in Body Mass Index (BMI) | Baseline and end of week 6 | Body mass index (kg/m2); change from baseline to the end of the six-week intervention. |
| Change in Body Fat Percentage | Baseline and end of week 6 | Body fat percentage (%) measured by multifrequency bioelectrical impedance analysis (InBody 270); change from baseline to the end of the six-week intervention. |
| Change in Fat Mass | Baseline and end of week 6 | Fat mass (kg) measured by multifrequency bioelectrical impedance analysis (InBody 270); change from baseline to the end of the six-week intervention. |
| Change in Skeletal Muscle Mass | Baseline and end of week 6 | Skeletal muscle mass (kg) measured by multifrequency bioelectrical impedance analysis (InBody 270); change from baseline to the end of the six-week intervention. |
| Waist Circumference | Baseline and end of week 6 | Changes in waist circumference (cm) measured by standard anthropometric tape from baseline to the end of the six-week intervention. |
| Fasting Blood Glucose (FBG) | Baseline and end of week 6 | Changes in fasting blood glucose (mg/dL) measured by standard automated clinical chemistry platform from baseline to the end of the six-week intervention. |
| Serum Insulin | Baseline and end of week 6 | Changes in serum insulin (µIU/mL) measured by immunoassay platform from baseline to the end of the six-week intervention. |
| HOMA-IR (Insulin Resistance) | Baseline and end of week 6 | Changes in HOMA-IR (calculated as fasting insulin x fasting glucose / 405) from baseline to the end of the six-week intervention. |
| Glycated Haemoglobin (HbA1c) | Baseline and end of week 6 | Changes in HbA1c (%) measured by immunoassay platform from baseline to the end of the six-week intervention. |
| Total Cholesterol (TC) | Baseline and end of week 6 | Changes in total cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to the end of the six-week intervention. |
| Triglycerides (TG) | Baseline and end of week 6 | Changes in serum triglycerides (mg/dL) measured by standard automated clinical chemistry platform from baseline to the end of the six-week intervention. |
| LDL Cholesterol (LDL-C) | Baseline and end of week 6 | Changes in LDL cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to the end of the six-week intervention. |
| HDL Cholesterol (HDL-C) | Baseline and end of week 6 | Changes in HDL cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to the end of the six-week intervention. |
| C-Reactive Protein (CRP) | Baseline and end of week 6 | Changes in serum C-reactive protein (mg/L) measured by high-sensitivity immunoassay from baseline to the end of the six-week intervention. |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORFazilet Erman, Dr
Firat University
STUDY_DIRECTORFeray Cagiran Yilmaz, Dr
Dicle University
STUDY_DIRECTOREsra Das, Msc
Firat University
Outcome results
None listed