Nonalcoholic Fatty LiverNCT07200934
Effect of Adding TENS to Mediterranean Diet on Appetite and Liver Enzymes in Nonalcoholic Fatty Liver Patients
A study testing Transcutaneous electrical stimulation (TENS) and Mediterranean Diet in people with Nonalcoholic Fatty Liver, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to identify the effect of adding TENS to the Mediterranean diet on appetite and liver enzymes in Nonalcoholic fatty liver patients. Read more about this study
- Who is it for?
- Ages 35 to 45 years, men only
- Conditions the study is for
- Nonalcoholic Fatty Liver
- What is being tested?
- Transcutaneous electrical stimulation (TENS) and Mediterranean Diet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2025to 14 Jan 2026
- 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 35 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- The age will range from 35-45 years old.
- BMI (Body Mass Index 30-34.9 kg/m2.)
- With fatty liver infiltration confirmed by abdominal ultrasound
- Elevated of liver enzymes as a primary marker
- All patients are psychologically stable.
Who cannot join
- History of cardiovascular or respiratory disease.
- If any known endocrine diseases e.g. Hypothyroidism (which elevates liver enzymes and effects on appetite)
- Any acute or chronic illness causing elevated liver enzymes other than fatty liver e.g. Hepatitis b, Hepatitis c
- Any neurological illness or impairment can effect on sensation
- Patients associated with infections, mental or malignant conditions.
- Patients who have undergone any gastric surgery e.g. Bariatric surgery
- Taking dietary supplement for weight reduction.
- Patients who participating in any other exercise program.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to identify the effect of adding TENS to the Mediterranean diet on appetite and liver enzymes in Nonalcoholic fatty liver patients.
Read the detailed description
Nonalcoholic fatty liver disease (NAFLD), also termed metabolic dysfunction-associated fatty liver disease, is one of the most common chronic liver diseases worldwide. The development of NAFLD is fueled by a sedentary lifestyle, low frequency of physical activity, unhealthy diet and excessive calorie intake. NAFLD is characterized by fat accumulation in the liver accounting for >5% of hepatic tissue weight (fatty liver), as well as liver inflammation, which is not caused by alcohol abuse.
NAFLD prevalence is on the rise, mainly due to the presence of the obesity epidemic. Nowadays, NAFLD has been suggested to affect approximately 25% of the population worldwide. they have found a greater increase among men than women regarding the prevalence of NAFLD. Moreover, its mortality is projected to approach an increase of 65% to 100% by 2030 in Asian-Pacific regions.
Globally, NAFLD prevalence averages 24.1%, ranging from 13.5% in Africa to 31.8% in the Middle East. Despite limited data on the extent of NAFLD in Egypt, the available data indicate a prevalence of nearly 32% among Egyptians, compared to a global prevalence of 25% Egypt ranks among the top ten countries with the highest obesity rates in the world.
Lifestyle modifications are the cornerstone of NAFLD management. A Mediterranean diet (MD), rich in whole grains, vegetables, fruits, nuts, and olive oil, is proven to improve liver health by reducing inflammation and fat accumulation.
Transcutaneous electrical stimulation (TENS) of T6 dermatome on the abdomen generates impulses which are carried to the spinal cord via afferent pathways, in turn, efferent impulses pass through the vagus nerve, and effects are induced similar to the gastric stimulator .This somato-autonomic reflex helps in decreasing appetite.
Therefore, the primary aim of this study it will impact future researcher about the beneficial effect of T6 dermatomal stimulation by the transcutaneous method in managing obesity, improving liver function and finally promoting body health related measure in non-alcoholic fatty liver patients.
- Conditions
- Nonalcoholic Fatty Liver
- Being tested
- Transcutaneous electrical stimulation (TENS), Mediterranean Diet
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical stimulation (TENS)Device
The negative/active pad surface electrode will be applied at the T6 dermatome on the abdomen (is located at the left upper quadrant of the abdomen, 2 cm below the ribcage at the left midclavicular line) for stimulation and the passive/positive electrode will be applied on the left T6 costovertebral junction to complete the circuit.
- The specific parameters of TENS will be burst mode, 2.0 Hz frequency, and 300 micro-seconds width
- The patients will receive 3 times 30 min session each week for a period of consecutive 12 weeks.
- The intensity of TENS will be gradually increased from 0 mA till the subject felt a comfortable tingling sensation beneath the electrode without any muscle contraction and pain.
Mediterranean DietOther
The recommended composition of Mediterranean diet regimen: is characterized by a high intake of plant foods, fruits, vegetables, breads and other cereals (traditionally minimally refined), potatoes, beans, nuts and seeds; minimally processed, fresh fruits as a typical dessert, with sweets containing sugars or honey a few times per week; .a high intake of olive oil (especially virgin and extra-virgin olive oil) as the main source of fat; a moderate intake of dairy products (mostly as cheese and yoghurt); zero to four eggs per week; low to moderate amounts of fish and poultry; low amounts of red meat. The diet plan included generally 50% carbohydrates (from vegetables, fruits, legumes, and whole grains), 35% fats (from healthy oils, nuts, seeds, and fish), and 15% protein (from legumes, fish, nuts, dairy, poultry, and eggs).
| Study group | Role | What they receive |
|---|---|---|
| TENS + Mediterranean Diet | Experimental | This group will consist of 25 patients, who will receive TENS treatment at T6 dermatome for 30 minutes, 3 times per week for 12 weeks, in addition to following Mediterranean diet for 12 weeks. Receives: Device: Transcutaneous electrical stimulation (TENS); Other: Mediterranean Diet |
| Mediterranean Diet | Active comparator | This group will consist of 25 patients, who will follow Mediterranean diet only for 12 weeks. Receives: Other: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale for appetite (VAS)
This method is used to evaluate the appetite level of fatty liver patients before and after treatment procedures. This method usually consists of a set of questions assessing hunger, fullness/satisfaction, desire to eat and prospective food intake the question is presented with a 100 mm horizontal line scale.
Measured: 12 weeks
Levels of liver transaminases aspartate transaminase (AST)
It will be measured pre and post-treatment for all participants in both groups.
Measured: 12 weeks
Levels of liver alanine transaminase (ALT)
It will be measured pre and post-treatment for all participants in both groups.
Measured: 12 weeks
Secondary outcomes (3)
Body mass index (BMI)
The BMI will be measured before and after treatment to measure the success of treatment procedures in losing weight for fatty liver patients.
Measured: 12 weeks
Relative fat mass (RFM)
The ratio of the patient's height and waist measurement, both in meters, is multiplied by 20 before being subtracted from a number that adjusts for differences in gender and height: RFM for adult Males: 64 - 20 × (height / waist circumference).This method is used to measure the success of treatment procedures in reducing fat mass of fatty liver patients.
Measured: 12 weeks
Fatigue Severity Scale (FSS)
Fatigue is considered the most common symptom for fatty liver patients Therefore we use this scale before and after treatment procedures. The FSS is a nine-item, self-reported questionnaire. Each item includes a seven-point, Likert-type response where 1 = "strongly disagree" and 7 = "strongly agree." indicates strong agreement.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start30 Sep 2025
- Primary completion30 Dec 2025
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty LiverStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Anwar Mohamed, Cairo University
- Investigators
- Nesreen Ghareeb El-Nahas, PhD, Study chair, Professor, Cairo universitySalma Ibrahim AL Ghitany, PhD, Study director, Lecturer, Cairo universityShawky Abdelhamid Fouad Abdel Gawad, Study director, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200934
- Sponsor's protocol ID
- P.T.REC/012/005933
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding TENS to Mediterranean Diet on Appetite and Liver Enzymes in Nonalcoholic Fatty Liver Patients
- ClinicalTrials.gov ID
- NCT07200934
- Acronym / sponsor ID
- P.T.REC/012/005933
- Conditions
- Nonalcoholic Fatty Liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 1 Oct 2025 (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 study aims to identify the effect of adding TENS to the Mediterranean diet on appetite and liver enzymes in Nonalcoholic fatty liver patients.
Detailed description
Nonalcoholic fatty liver disease (NAFLD), also termed metabolic dysfunction-associated fatty liver disease, is one of the most common chronic liver diseases worldwide. The development of NAFLD is fueled by a sedentary lifestyle, low frequency of physical activity, unhealthy diet and excessive calorie intake. NAFLD is characterized by fat accumulation in the liver accounting for >5% of hepatic tissue weight (fatty liver), as well as liver inflammation, which is not caused by alcohol abuse.
NAFLD prevalence is on the rise, mainly due to the presence of the obesity epidemic. Nowadays, NAFLD has been suggested to affect approximately 25% of the population worldwide. they have found a greater increase among men than women regarding the prevalence of NAFLD. Moreover, its mortality is projected to approach an increase of 65% to 100% by 2030 in Asian-Pacific regions.
Globally, NAFLD prevalence averages 24.1%, ranging from 13.5% in Africa to 31.8% in the Middle East. Despite limited data on the extent of NAFLD in Egypt, the available data indicate a prevalence of nearly 32% among Egyptians, compared to a global prevalence of 25% Egypt ranks among the top ten countries with the highest obesity rates in the world.
Lifestyle modifications are the cornerstone of NAFLD management. A Mediterranean diet (MD), rich in whole grains, vegetables, fruits, nuts, and olive oil, is proven to improve liver health by reducing inflammation and fat accumulation.
Transcutaneous electrical stimulation (TENS) of T6 dermatome on the abdomen generates impulses which are carried to the spinal cord via afferent pathways, in turn, efferent impulses pass through the vagus nerve, and effects are induced similar to the gastric stimulator .This somato-autonomic reflex helps in decreasing appetite.
Therefore, the primary aim of this study it will impact future researcher about the beneficial effect of T6 dermatomal stimulation by the transcutaneous method in managing obesity, improving liver function and finally promoting body health related measure in non-alcoholic fatty liver patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS + Mediterranean Diet | Experimental | Device: Transcutaneous electrical stimulation (TENS), Other: Mediterranean DietThis group will consist of 25 patients, who will receive TENS treatment at T6 dermatome for 30 minutes, 3 times per week for 12 weeks, in addition to following Mediterranean diet for 12 weeks. |
| Mediterranean Diet | Active comparator | Other: Mediterranean DietThis group will consist of 25 patients, who will follow Mediterranean diet only for 12 weeks. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The age will range from 35-45 years old.
- BMI (Body Mass Index 30-34.9 kg/m2.)
- With fatty liver infiltration confirmed by abdominal ultrasound
- Elevated of liver enzymes as a primary marker
- All patients are psychologically stable.
Key exclusion criteria (8 listed)
- History of cardiovascular or respiratory disease.
- If any known endocrine diseases e.g. Hypothyroidism (which elevates liver enzymes and effects on appetite)
- Any acute or chronic illness causing elevated liver enzymes other than fatty liver e.g. Hepatitis b, Hepatitis c
- Any neurological illness or impairment can effect on sensation
- Patients associated with infections, mental or malignant conditions.
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 |
|---|---|---|
| Transcutaneous electrical stimulation (TENS)The negative/active pad surface electrode will be applied at the T6 dermatome on the abdomen (is located at the left upper quadrant of the abdomen, 2 cm below the ribcage at the left midclavicular line) for stimulation and the passive/positive electrode will be applied on the left T6 costovertebral junction to complete the circuit. * The specific parameters of TENS will be burst mode, 2.0 Hz frequency, and 300 micro-seconds width * The patients will receive 3 times 30 min session each week for a period of consecutive 12 weeks. * The intensity of TENS will be gradually increased from 0 mA till the subject felt a comfortable tingling sensation beneath the electrode without any muscle contraction and pain. | Device | TENS + Mediterranean Diet |
| Mediterranean DietThe recommended composition of Mediterranean diet regimen: is characterized by a high intake of plant foods, fruits, vegetables, breads and other cereals (traditionally minimally refined), potatoes, beans, nuts and seeds; minimally processed, fresh fruits as a typical dessert, with sweets containing sugars or honey a few times per week; .a high intake of olive oil (especially virgin and extra-virgin olive oil) as the main source of fat; a moderate intake of dairy products (mostly as cheese and yoghurt); zero to four eggs per week; low to moderate amounts of fish and poultry; low amounts of red meat. The diet plan included generally 50% carbohydrates (from vegetables, fruits, legumes, and whole grains), 35% fats (from healthy oils, nuts, seeds, and fish), and 15% protein (from legumes, fish, nuts, dairy, poultry, and eggs). | Other | Mediterranean Diet, TENS + Mediterranean Diet |
Primary outcome
Visual analogue scale for appetite (VAS)
Time frame: 12 weeks
This method is used to evaluate the appetite level of fatty liver patients before and after treatment procedures. This method usually consists of a set of questions assessing hunger, fullness/satisfaction, desire to eat and prospective food intake the question is presented with a 100 mm horizontal line scale.
Levels of liver transaminases aspartate transaminase (AST)
Time frame: 12 weeks
It will be measured pre and post-treatment for all participants in both groups.
Levels of liver alanine transaminase (ALT)
Time frame: 12 weeks
It will be measured pre and post-treatment for all participants in both groups.
3 secondary outcomes
Body mass index (BMI)
Time frame: 12 weeks
Relative fat mass (RFM)
Time frame: 12 weeks
Fatigue Severity Scale (FSS)
Time frame: 12 weeks
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 22 Sep 2026.
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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.
Nesreen Ghareeb El-Nahas, PhD study chair
Professor, Cairo university
Salma Ibrahim AL Ghitany, PhD study director
Lecturer, Cairo university
Shawky Abdelhamid Fouad Abdel Gawad study director
Professor, Cairo 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 Transcutaneous electrical stimulation (TENS) and Mediterranean Diet in people with Nonalcoholic Fatty Liver, run by Cairo University at 1 site in Egypt.
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 8 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 22 Sep 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 Egypt. 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?
Visual analogue scale for appetite (VAS) (time frame: 12 weeks). The study lists 3 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 22 Sep 2026.