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

Cairo University (CU) logo

Cairo University (CU)

Status

Not yet enrolling

Conditions

Nonalcoholic Fatty Liver

Treatments

Other: Mediterranean Diet
Device: Transcutaneous electrical stimulation (TENS)

Study type

Interventional

Funder types

Other

Identifiers

NCT07200934
P.T.REC/012/005933

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

Male

Ages

35 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

TENS + Mediterranean Diet
Experimental group
Description:
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.
Treatment:
Device: Transcutaneous electrical stimulation (TENS)
Other: Mediterranean Diet
Mediterranean Diet
Active Comparator group
Description:
This group will consist of 25 patients, who will follow Mediterranean diet only for 12 weeks.
Treatment:
Other: Mediterranean Diet

Trial contacts and locations

1

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Central trial contact

Doaa Anwar Mohamed Ali, B.Sc; Salma Ibrahim AL Ghitany, PhD

Data sourced from clinicaltrials.gov

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