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

Overview

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.

Interventions

• Device 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
• Other 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 y

Primary outcome measures

• Visual analogue scale for appetite (VAS) [Time frame: 12 weeks]
• Levels of liver transaminases aspartate transaminase (AST) [Time frame: 12 weeks]
• Levels of liver alanine transaminase (ALT) [Time frame: 12 weeks]

Secondary outcome measures (3)

• Body mass index (BMI) [Time frame: 12 weeks]
• Relative fat mass (RFM) [Time frame: 12 weeks]
• Fatigue Severity Scale (FSS) [Time frame: 12 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Internal Medicine Hospital Cairo University — Giza

Identifiers

NCT: NCT07200934 · P.T.REC/012/005933

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗