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

NCT ID: NCT06666894

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-06-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intermittent fasting group

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)

Group Type: EXPERIMENTAL

Intermittent fasting

Intervention Type: OTHER

subjects consumed 100 % of their energy needs in an 8-h 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. The remaining 16 h per 24-h period made up the fasting period. Subjects in the ND group consumed 100 % of their energy needs divided into three meals consumed at 8 a.m., 1 p.m., and 8 p.m. all patients will be subjected to 30 minutes mild aerobic exercise on treadmill.

Diet group

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).

Group Type: ACTIVE_COMPARATOR

Dietary approach to stop hypertension (DASH)

Intervention Type: OTHER

The USDA's 2015-2020 Dietary Guidelines for Americans recommend a healthy eating pattern, including a variety of vegetables, fruits, whole grains, fat-free dairy, protein, and oils. Limit saturated fats, trans fats, added sugars, and sodium to less than 10% daily calories, 10% saturated fat daily calories, and 2,300 mg sodium per day.

Interventions

Intermittent fasting

subjects consumed 100 % of their energy needs in an 8-h 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. The remaining 16 h per 24-h period made up the fasting period. Subjects in the ND group consumed 100 % of their energy needs divided into three meals consumed at 8 a.m., 1 p.m., and 8 p.m. all patients will be subjected to 30 minutes mild aerobic exercise on treadmill.

Intervention Type: OTHER

Dietary approach to stop hypertension (DASH)

The USDA's 2015-2020 Dietary Guidelines for Americans recommend a healthy eating pattern, including a variety of vegetables, fruits, whole grains, fat-free dairy, protein, and oils. Limit saturated fats, trans fats, added sugars, and sodium to less than 10% daily calories, 10% saturated fat daily calories, and 2,300 mg sodium per day.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aya Gamal Khattab Omer

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

out-patient clinic, faculty of physical therapy, Cairo university

Giza, , Egypt

Countries

Egypt

Other Identifiers

Aya-005258

Identifier Type: -

Identifier Source: org_study_id