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

Not Applicable

Completed

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

• Registration Number: NCT06666894
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-06-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-10-29
• Last Update Submitted: 2024-10-29
• Study First Posted: 2024-10-31
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
assessment of Non-alcoholic fatty liver using ultrasonography	at baseline at after two months	usage of diagnostic ultrasound to diagnose patients with non-alcoholic fatty liver disease

Secondary Outcome Measures

Name	Time	Method
assessment of change of lab profile using laboratory investigations	at baseline at after two months	The study focuses on lipid profiles, glucose and insulin profiles, IL-6, and C- reactive protein. Blood samples are collected from the antecubital vein at baseline and after 8 weeks, and analyzed using the same reagent lot. Fasting total cholesterol, HDL-C, LDL-C, and triglycerides are measured using an enzymatic colorimetric method. LDL-C fraction is calculated using Friedewald's formula. Laboratory investigation before and after the study is conducted.
assessment of change of body mass index	at baseline at after two months	Anthropometric baseline characteristics of subjects by In Body 170 Pre \& post the study being performed (BMI)
assessment of macronutrients distribution	at baseline at after two months	• Dietary assessment for macronutrients distribution by dietary 24-hour recall Highlighted among dietary assessment methods of the current diet for their interest \& validity. It is a prospective, open ended survey method collecting data about the foods \& beverages consumed over a previously specified period of time.

Trial Locations

Locations (1)

out-patient clinic, faculty of physical therapy, Cairo university; 🇪🇬 Giza, Egypt