Effectiveness of Nutrition Education Program and Omega-3 Supplementation on Body Weight, Liver Enzymes, Lipid Profile Among Non-Alcoholic Fatty Liver Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Comparision the effectiveness of nutrition education and Omega-3 supplementation on reduction in hepatic steatosis scores.
研究概览
简要总结
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.
详细描述
159 participants with non-alcoholic fatty liver disease patient who will attend Rizgary Teaching Hospital in Erbil City.
In order to obtain the accurate data and representative sample, Eligible patients will be randomized to one of three arms:
- those who will receive nutritional education (For nutritional education intervention, Theory of planned behavior-based interventions for the non-alcoholic fatty liver disease patients will include three educational sessions).
- those who will receive omega-3 supplements (the dose of omega-3 (DHA+ EPA) will be 1000 mg twice daily).
or 3. to a control group who will not receive any intervention, (who receive routine care at the outpatient clinic).
Data collection will depend on face-to-face interviews including baseline, using validated questionnaires, ultrasonography and laboratory test (liver enzyme and lipid profile) at first visit, mid and after 12 weeks of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-74 years' old.
- •Ability to use a mobile phone.
- •Ultrasound examination diagnosed Patients with grade 1 and 2 non-alcoholic fatty liver disease.
排除标准
- •supplementary intakes of n-3 PUFA within the previous 6 months.
- •pregnancy or breastfeeding.
- •chronic liver disease of other causes (autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, hereditary haemochromatosis, Wilson's disease, a1-anti-trypsin deficiency, coeliac disease).
- •hormone therapy and use of drugs like amiodarone, methotrexate, and corticosteroid.
- •three months.
- •chronic disease such as cardiovascular, gastrointestinal, thyroid, renal, cancer or pancreatic that assessed by a specialist.
- •The use of drugs known to be associated with liver steatosis (Drugs known to be capable of inducing steatosis and steatohepatitis can be divided into three broad groups: those that cause steatosis and steatohepatitis independently (e.g., amiodarone, perhexiline maleate); drugs which can precipitate latent NASH (e.g., tamoxifen); drugs which induce sporadic events of steatosis/steatohepatitis (e.g., carbamazepine).
研究组 & 干预措施
Nutrition education Program
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.
干预措施: nutrition education program (Behavioral)
control
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.
干预措施: control group (Other)
Omega-3 supplementation
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.
干预措施: Omega 3 fatty acids (Dietary Supplement)
结局指标
主要结局
Comparision the effectiveness of nutrition education and Omega-3 supplementation on reduction in hepatic steatosis scores.
时间窗: 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.
时间窗: 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.
时间窗: 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 .
次要结局
- comparison the effectiveness of nutrition education and omega-3 supplementation on changes in body weight measurements.(the time frame of the body weight measurement from baseline to through study completion, an average of 12 weeks.)
- comparison the effectiveness of nutrition education and omega-3 supplementation on changes in waist circumference measurements.(the time frame of the waist circumference measurement from baseline to through study completion, an average of 12 weeks.)
- comparison the effectiveness of nutrition education and omega-3 supplementation on changes in Body mass index measurements.(the time frame of the BMI measurement from baseline to through study completion, an average of 12 weeks.)
研究者
Dilkhosh Shamal Ramadhan
lecturer
Hawler Medical University