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COMPLETED
NCT07675382
NA

NMES Plus Hypocaloric Diet: Body Composition, Cardiometabolic Markers, Irisin and Betatrophin in Women With Obesity

Sponsor: Firat University

View on ClinicalTrials.gov

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.

Official title: Effects of Neuromuscular Electrical Stimulation Combined With a Hypocaloric Diet on Body Composition, Cardiometabolic Markers, Irisin and Betatrophin in Women With Obesity: A Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2025-02-02

Completion Date

2025-08-24

Last Updated

2026-10-09

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Hypocaloric 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.

DEVICE

Neuromuscular 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).

Locations (1)

Dicle University, Department of Nutrition and Dietetics

Diyarbakır, Turkey (Türkiye)