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Effectiveness of Nutrition Education Program and Omega-3 Supplementation on Body Weight, Liver Enzymes, Lipid Profile Among Non-Alcoholic Fatty Liver Disease Patients
The aim of this clinical trial is to examine the impact of nutritional education and omega-3 supplementation in influencing body weight, liver enzyme levels, and lipid profiles in patients diagnosed with non-alcoholic fatty liver disease. Eligible patients who have non-alcoholic fatty liver disease are randomized to receive either nutritional education, omega-3 fatty acids containing DHA and EPA, or control groups. the main questions are: Does the Nutrition education affect body mass, liver enzyme and lipid profile in patient with non-alcoholic fatty liver disease? Does Omega-3 supplementation affect body mass, liver enzyme and lipid profile in patient with non-alcoholic fatty liver disease? The expected outcome will improvement in the laboratory liver tests, liver steatosis on ultrasound, and lipid profile and also decrease body weight.
Details
| Lead sponsor | Hawler Medical University |
|---|---|
| Phase | NA |
| Status | NOT_YET_RECRUITING |
| Enrolment | 159 |
| Start date | 2024-11-01 |
| Completion | 2026-09 |
Conditions
- Non-alcoholic Fatty Liver Disease (NAFLD)
- Omega-3 Supplementation
- Nutrition Education Program
Interventions
- nutrition education program
- Omega 3 fatty acids
- control group
Primary outcomes
- Comparision the effectiveness of nutrition education and Omega-3 supplementation on reduction in hepatic steatosis scores. — hepatic steatosis scores the measurement will be taken at the baseline and through study completion, an average of 12 weeks.
The first primary outcome measures will be the reduction in hepatic steatosis scores, will be assess by using ultrasound. The diagnosis of fatty liver will be based on parenchymal brightness, liver-to-kidney contrast, bright vessel walls, gallbladder wall definition, and diaphragmatic definition. The fatty disease will be graded and labeled as mild, moderate, or severe, or grades 0 to 3 (with 0 being normal) based on the degree of parenchymal brightness. Grade 0 (normal liver): the liver and renal cortex are of similar echogenicity. Grade 1 (mild): slight diffuse increase in the fine echoes of liver parenchyma with appreciable periportal and diaphragmatic echogenicity. Grade 2 (moderate): moderately diffuse increase in fine echoes of the liver parenchyma obscuring periportal echogenicity, but diaphragmatic echogenicity is still appreciable. - Comparision the effectiveness of nutrition education and Omega-3 supplementation on changes in serum concentrations of liver enzymes. — liver enzymes measurement will be taken at the baseline and through study completion, an average of 12 weeks.
Description: The second primary outcome measures will be the changes in serum concentrations of liver enzymes (AST, ALT, ALP and GGT). Established methods will use to test the liver's biochemical parameters, that will be measure through using enzymatic colorimetric assays. - Comparision the effectiveness of nutrition education and Omega-3 supplementation on changes in serum concentrations of lipid profile. — lipid profile measurement will be taken at the baseline and through study completion, an average of 12 weeks.
Description: The third primary outcome measures will be the changes in serum concentrations of lipid profile (Triglycerides, Total cholesterol, LDL-c and HDL-c). Serum TG, TC, HDL-c will be determined by enzymatic colorimetric assay method. The Friedewald formula has long been used to calculate LDL-c from total cholesterol, triglyceride, and HDL-c .
Countries
Iraq