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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| assessment of change of lab profile using laboratory investigations | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| out-patient clinic, faculty of physical therapy, Cairo university | Giza | Egypt |
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| 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. |
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| at baseline at after two months |
| assessment of change of body mass index | Anthropometric baseline characteristics of subjects by In Body 170 Pre & post the study being performed (BMI) | at baseline at after two months |
| assessment of macronutrients distribution | • 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. | at baseline at after two months |
| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| D006973 | Hypertension |
| D024821 | Metabolic Syndrome |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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