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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age35-45
SponsorCairo University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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).

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: TENS + Mediterranean DietExperimental treatment 2 interventions
Group B: Mediterranean DietActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks
2

Levels of liver transaminases aspartate transaminase (AST)

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

Time frame
12 weeks
3

Levels of liver alanine transaminase (ALT)

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

Time frame
12 weeks

Secondary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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