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

NCT06666894 | Completed

• 1 other identifier: Aya-005258
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• assessment of Non-alcoholic fatty liver using ultrasonography

  usage of diagnostic ultrasound to diagnose patients with non-alcoholic fatty liver disease

  at baseline at after two months

Secondary Outcomes (3)

• assessment of change of lab profile using laboratory investigations

  at baseline at after two months

• assessment of change of body mass index

  at baseline at after two months

• assessment of macronutrients distribution

  at baseline at after two months

Study Arms (2)

Intermittent fasting group

EXPERIMENTAL

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)

Other: Intermittent fasting

Diet group

ACTIVE COMPARATOR

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).

Other: Dietary approach to stop hypertension (DASH)

Interventions

Intermittent fasting 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.

Intermittent fasting group

Dietary approach to stop hypertension (DASH) 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.

Diet group

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Giza, Egypt

Location

MeSH Terms

Conditions

Intermittent Fasting; Hypertension; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 31, 2024
• Study Start: January 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

EG (1)