At a glance
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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
In Brief
A clinical study evaluating nutrition education program, Omega 3 fatty acids, and 1 other intervention for Non-alcoholic Fatty Liver Disease (NAFLD) and 2 related conditions. Completed, enrolled 159 participants across 1 site.
Signals
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
patients randomized to the intervention group, will participate in a nutritional education. the nutrition education sessions will be based on theory of planned behavior, which will include three 45-60-minute sessions about understanding NAFLD and nutrition basics, the role of social influences and support systems in managing NAFLD and overcoming barriers and building confidence. Several educational methods will be using such as lectures, slides, group discussion, question and answers, instructional images, poster, booklet and Use case studies or scenarios. Participants will encourage to increase the intake of fruits, vegetables, complex carbohydrate, low fat dairy, healthy fats, white meat and fish, and also avoid the intake of unhealthy fats and refined carbohydrates. Furthermore, in each session, will be reviewing the patients' dietary practice and provided recommendations. Adherence to dietary intervention will assess by weekly phone calls and dietary records.
Omega-3 Arm:1000 mg omega-3 fatty acids soft gel capsules (containing DHA 220 mg and EPA 330 mg) in two dose per day, to be taken orally with meal. Planned duration of the treatment is 12 weeks.
Patients randomized to the control group, who receive routine care at the outpatient clinic in Rizgari teaching hospital. At baseline, a physician will explain the laboratory test results and the natural history of NAFLD to the patients.
Interventions
Nutritional Guidance: Emphasizing a balanced diet rich in fruits, vegetables, whole grains, lean proteins, and healthy fats while reducing processed foods, sugars, and saturated fats. Weight Management: Encouraging gradual weight loss if overweight, as this can significantly improve liver health. Individualized Plans: Tailoring nutrition education to the individual needs, preferences, and any other underlying health conditions. Monitoring and Support: Providing ongoing support and education to help participants make sustainable changes and track their progress.
Omega-3 Arm:1000 mg omega-3 fatty acids soft gel capsules twice daily, to be taken orally with meal.
receive routine care at the outpatient clinic. At baseline, a physician will explain the laboratory test results and the natural history of NAFLD to the patients.