Intermittent Fasting Versus Diet to Stop Hypertension on Metabolic Risk Profile in Nonalcoholic Fatty Liver Patients

Cairo University (CU)

Status: Completed

Conditions: Hypertension; Diet; Non-Alcoholic Fatty Liver Disease; Metabolic Syndrome; Fasting, Intermittent

Treatments: Other: Intermittent fasting; Other: Dietary approach to stop hypertension (DASH)

Study type: Interventional

Funder types: Other

Identifiers

NCT06666894

Aya-005258

Details and patient eligibility

About

This study was conducted to compare between the effect of intermittent fasting and diatery approach to stop hypertension on metabolic risk profile in nonalcoholic fatty liver patients.

Full description

Non-alcoholic fatty liver is a liver disease linked to obesity, insulin resistance, type 2 diabetes, hypertension, hyperlipidemia, and metabolic syndrome. The subtype, non-alcoholic steatohepatitis, can lead to liver fibrosis, cirrhosis, hepatocellular carcinoma, and liver transplantation. The prevalence of Non-alcoholic fatty liver disease is increasing at the same rate as obesity, with the global prevalence estimated at 25%. By 2020, the burden of Non-alcoholic fatty liver is expected to exceed that of communicable disease in most regions.

Enrollment: 40 patients

Sex: All

Ages: 30 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-alcoholic fatty liver patients diagnosed by radiological ultrasound
• BMI >30
• All patients are sedentary lifestyle with little or no exercise.
• High lipid profile (total cholesterol > 200, LDL > 130, TAGs > 150) patients by laboratory investigation.
• High fasting insulin level > 20mlU/mL & high fasting Glucose level >100, HbA1c > 5.7 & high HOMA- IR > 2.5 patients by Laboratory investigation.
• High inflammatory markers (IL6) patients.
• Age ranged from 30 to 40 years old.

Exclusion criteria

• Alcoholic fatty liver patients.
• Cirrhosis patients.
• Diabetes patients.
• Cognitive impaired patients.
• History of epilepsy patients.
• Cardiac pacemaker patients.
• Anemic patients
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intermittent fasting group

Experimental group

Description:

intermittent fasting time-restricted feeding (TRF) subjects consumed 100 % of their energy needs in an 8 hours period of time each day, with their caloric intake divided into three meals consumed at 1 p.m., 4 p.m., and 8 p.m. schedule (8-hr daily eating period, The remaining 16 hours per 24-hour period made up the fasting period)

Treatment:

Other: Intermittent fasting

Diet group

Active Comparator group

Description:

the dietary approach to stop hypertension (DASH) subjects consumed 100 % of their energy needs divided into three meals consumed at 8 a.m., 1 p.m., and 8 p.m. (12-hr eating period).

Treatment:

Other: Dietary approach to stop hypertension (DASH)