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NCT Number: NCT06666894

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

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.

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Key information

Conditions

Fasting, Intermittent Behavior Cardiovascular Diseases Diet Digestive System Diseases Fasting Fatty Liver Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Intermittent Fasting Liver Diseases Metabolic Diseases Metabolic Syndrome Non-Alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases Vascular Diseases

Age range

30 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. assessment of Non-alcoholic fatty liver using ultrasonography

    Time frame: at baseline at after two months

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

Secondary outcomes

  1. assessment of change of lab profile using laboratory investigations

    Time frame: 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.

  2. assessment of change of body mass index

    Time frame: at baseline at after two months

    Anthropometric baseline characteristics of subjects by In Body 170 Pre & post the study being performed (BMI)

  3. assessment of macronutrients distribution

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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