Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07200934

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

This study aims to identify the effect of adding TENS to the Mediterranean diet on appetite and liver enzymes in Nonalcoholic fatty liver patients.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

35 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 Diet

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).

Primary outcomes

  1. 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.

  2. 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.

  3. Levels of liver alanine transaminase (ALT)

    Time frame: 12 weeks

    It will be measured pre and post-treatment for all participants in both groups.

Secondary outcomes

  1. Body mass index (BMI)

    Time frame: 12 weeks

    The BMI will be measured before and after treatment to measure the success of treatment procedures in losing weight for fatty liver patients.

  2. Relative fat mass (RFM)

    Time frame: 12 weeks

    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.

  3. Fatigue Severity Scale (FSS)

    Time frame: 12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Doaa Anwar Mohamed Ali, B.Sc

CONTACT

[email protected]

+20 100 310 8951

Salma Ibrahim AL Ghitany, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.