Effect of Adding TENS to Mediterranean Diet on Appetite and Liver Enzymes in Nonalcoholic Fatty Liver Patients

NCT ID: NCT07200934

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-01-14

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TENS + Mediterranean Diet

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.

Group Type: EXPERIMENTAL

Transcutaneous electrical stimulation (TENS)

Intervention Type: 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 Diet

Intervention Type: OTHER

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).

Mediterranean Diet

This group will consist of 25 patients, who will follow Mediterranean diet only for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Mediterranean Diet

Intervention Type: OTHER

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).

Interventions

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.

Intervention Type: DEVICE

Mediterranean Diet

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Doaa Anwar Mohamed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nesreen Ghareeb El-Nahas, PhD

Role: STUDY_CHAIR

Professor, Cairo university

Salma Ibrahim AL Ghitany, PhD

Role: STUDY_DIRECTOR

Lecturer, Cairo university

Shawky Abdelhamid Fouad Abdel Gawad

Role: STUDY_DIRECTOR

Professor, Cairo university

Locations

Internal Medicine Hospital Cairo University

Giza, , Egypt

Countries

Egypt

Central Contacts

Doaa Anwar Mohamed Ali, B.Sc

Role: CONTACT

dr.doaanwar@hotmail.com

+20 100 310 8951

Salma Ibrahim AL Ghitany, PhD

Role: CONTACT

Facility Contacts

Doaa Anwar Mohamed Ali, B.Sc

Role: primary

dr.doaanwar@hotmail.com

+20 100 310 8951

Other Identifiers

P.T.REC/012/005933

Identifier Type: -

Identifier Source: org_study_id