Diet, Fasting, Intermittent, Hypertension, Metabolic Syndrome, Non-Alcoholic Fatty Liver Disease
Conditions
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.
Interventions
OTHERIntermittent 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.
OTHERDietary 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed