ObesityNCT07675382
NMES Plus Hypocaloric Diet: Body Composition, Cardiometabolic Markers, Irisin and Betatrophin in Women With Obesity
A study testing Hypocaloric Diet and Neuromuscular Electrical Stimulation (NMES) in people with Obesity, run by Firat University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Hypocaloric Diet and Neuromuscular Electrical Stimulation (NMES)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2025to 24 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dicle University, Department of Nutrition and Dietetics
Diyarbakır
About this study
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
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Hypocaloric Diet, Neuromuscular Electrical Stimulation (NMES)
- Keywords
- Neuromuscular electrical stimulation, Irisin, Betatrophin, ANGPTL8, Hypocaloric diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypocaloric DietBehavioural
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.
Neuromuscular Electrical Stimulation (NMES)Device
Also called Electrical muscle stimulation
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).
| Study group | Role | What they receive |
|---|---|---|
| Diet Only | Active comparator | Individualized hypocaloric diet for six weeks (total energy expenditure estimated with the Mifflin-St Jeor equation multiplied by a physical activity coefficient of 1.3, minus 500 kcal/day; additional 5-10% restriction at a weight-loss plateau), with weekly online follow-up by a dietitian. Receives: Behavioral: Hypocaloric Diet |
| Diet + NMES | Experimental | The same individualized hypocaloric diet for six weeks plus localized neuromuscular electrical stimulation (NMES) of the abdominal and gluteal muscles, twice weekly (12 sessions of 20-25 minutes). Receives: Behavioral: Hypocaloric Diet; Device: Neuromuscular Electrical Stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Irisin Concentration
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.
Measured: Baseline and end of week 6
Change in Serum Betatrophin (ANGPTL8) Concentration
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.
Measured: Baseline and end of week 6
Secondary outcomes (15)
Change in Body Weight
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.
Measured: Baseline and end of week 6
Change in Body Mass Index (BMI)
Body mass index (kg/m2); change from baseline to the end of the six-week intervention.
Measured: Baseline and end of week 6
Change in Body Fat Percentage
Body fat percentage (%) measured by multifrequency bioelectrical impedance analysis (InBody 270); change from baseline to the end of the six-week intervention.
Measured: Baseline and end of week 6
Change in Fat Mass
Fat mass (kg) measured by multifrequency bioelectrical impedance analysis (InBody 270); change from baseline to the end of the six-week intervention.
Measured: Baseline and end of week 6
Change in Skeletal Muscle Mass
Skeletal muscle mass (kg) measured by multifrequency bioelectrical impedance analysis (InBody 270); change from baseline to the end of the six-week intervention.
Measured: Baseline and end of week 6
Waist Circumference
Changes in waist circumference (cm) measured by standard anthropometric tape from baseline to the end of the six-week intervention.
Measured: Baseline and end of week 6
Fasting Blood Glucose (FBG)
Changes in fasting blood glucose (mg/dL) measured by standard automated clinical chemistry platform from baseline to the end of the six-week intervention.
Measured: Baseline and end of week 6
Serum Insulin
Changes in serum insulin (µIU/mL) measured by immunoassay platform from baseline to the end of the six-week intervention.
Measured: Baseline and end of week 6
HOMA-IR (Insulin Resistance)
Changes in HOMA-IR (calculated as fasting insulin x fasting glucose / 405) from baseline to the end of the six-week intervention.
Measured: Baseline and end of week 6
Glycated Haemoglobin (HbA1c)
Changes in HbA1c (%) measured by immunoassay platform from baseline to the end of the six-week intervention.
Measured: Baseline and end of week 6
Total Cholesterol (TC)
Changes in total cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to the end of the six-week intervention.
Measured: Baseline and end of week 6
Triglycerides (TG)
Changes in serum triglycerides (mg/dL) measured by standard automated clinical chemistry platform from baseline to the end of the six-week intervention.
Measured: Baseline and end of week 6
LDL Cholesterol (LDL-C)
Changes in LDL cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to the end of the six-week intervention.
Measured: Baseline and end of week 6
HDL Cholesterol (HDL-C)
Changes in HDL cholesterol (mg/dL) measured by standard automated clinical chemistry platform from baseline to the end of the six-week intervention.
Measured: Baseline and end of week 6
C-Reactive Protein (CRP)
Changes in serum C-reactive protein (mg/L) measured by high-sensitivity immunoassay from baseline to the end of the six-week intervention.
Measured: Baseline and end of week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start2 Feb 2025
- Primary completion24 Aug 2025
- Study completion24 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Collaborators
- Dicle University
- Responsible party
- Principal investigator, Murat Açık, Firat University
- Investigators
- Fazilet Erman, Dr, Study director, Firat UniversityFeray Cagiran Yilmaz, Dr, Study director, Dicle UniversityEsra Das, Msc, Study director, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675382
- Sponsor's protocol ID
- FU_MAcik_WB-EMS_2025
- Other IDs
- 2025/01-46
- Status last verified
- Oct 2026
- First submitted
- 17 Jun 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not publicly available because of institutional data-protection provisions and the terms of informed consent; de-identified data are available from the corresponding author upon reasonable request, subject to approval by the relevant ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07675382
- Acronym / sponsor ID
- FU_MAcik_WB-EMS_2025
- Conditions
- Obesity
- Keywords
- Neuromuscular electrical stimulation, Irisin, Betatrophin, ANGPTL8, Hypocaloric diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Collaborators
- Dicle University
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 24 Aug 2025 (actual)
- Study completion
- 24 Aug 2025 (actual)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet Only | Active comparator | Behavioral: Hypocaloric DietIndividualized hypocaloric diet for six weeks (total energy expenditure estimated with the Mifflin-St Jeor equation multiplied by a physical activity coefficient of 1.3, minus 500 kcal/day; additional 5-10% restriction at a weight-loss plateau), with weekly online follow-up by a dietitian. |
| Diet + NMES | Experimental | Behavioral: Hypocaloric Diet, Device: Neuromuscular Electrical Stimulation (NMES)The same individualized hypocaloric diet for six weeks plus localized neuromuscular electrical stimulation (NMES) of the abdominal and gluteal muscles, twice weekly (12 sessions of 20-25 minutes). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypocaloric DietIndividualized 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. | Behavioural | Diet + NMES, Diet Only |
| Neuromuscular Electrical Stimulation (NMES)Also: Electrical muscle stimulationLocalized 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). | Device | Diet + NMES |
Primary outcome
Change in Serum Irisin Concentration
Time frame: 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
Time frame: 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.
15 secondary outcomes
Change in Body Weight
Time frame: Baseline and end of week 6
Change in Body Mass Index (BMI)
Time frame: Baseline and end of week 6
Change in Body Fat Percentage
Time frame: Baseline and end of week 6
Change in Fat Mass
Time frame: Baseline and end of week 6
Change in Skeletal Muscle Mass
Time frame: Baseline and end of week 6
Waist Circumference
Time frame: Baseline and end of week 6
Fasting Blood Glucose (FBG)
Time frame: Baseline and end of week 6
Serum Insulin
Time frame: Baseline and end of week 6
HOMA-IR (Insulin Resistance)
Time frame: Baseline and end of week 6
Glycated Haemoglobin (HbA1c)
Time frame: Baseline and end of week 6
Total Cholesterol (TC)
Time frame: Baseline and end of week 6
Triglycerides (TG)
Time frame: Baseline and end of week 6
LDL Cholesterol (LDL-C)
Time frame: Baseline and end of week 6
HDL Cholesterol (HDL-C)
Time frame: Baseline and end of week 6
C-Reactive Protein (CRP)
Time frame: Baseline and end of week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are not publicly available because of institutional data-protection provisions and the terms of informed consent; de-identified data are available from the corresponding author upon reasonable request, subject to approval by the relevant ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fazilet Erman, Dr study director
Firat University
Feray Cagiran Yilmaz, Dr study director
Dicle University
Esra Das, Msc study director
Firat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypocaloric Diet and Neuromuscular Electrical Stimulation (NMES) in people with Obesity, run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Irisin Concentration (time frame: Baseline and end of week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.