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

NCT07200934 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-10-01

No results posted yet for this study

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.

Conditions

  • Nonalcoholic Fatty Liver

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 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.

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 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).

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Nesreen Ghareeb El-Nahas, PhD · Professor, Cairo university

  • Salma Ibrahim AL Ghitany, PhD · Lecturer, Cairo university

  • Shawky Abdelhamid Fouad Abdel Gawad · Professor, Cairo university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2025-12-30
Completion
2026-01-14

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07200934 on ClinicalTrials.gov