Non-alcoholic Fatty Liver Disease (NAFLD)NCT06627114
Effectiveness of Nutrition Education Program and Omega-3 Supplementation Among Non-alcoholic Fatty Liver Disease Patients
A study testing nutrition education program and Omega 3 fatty acids in people with Non-alcoholic Fatty Liver Disease (NAFLD) and Omega-3 Supplementation, run by Hawler Medical University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease (NAFLD), Omega-3 Supplementation, Nutrition Education Program
- What is being tested?
- nutrition education program and Omega 3 fatty acids
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteIraq
- Study dates
- 29 Oct 2024to 3 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed description
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
- 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.
Tools for data collection The questionnaire that will be developed for the purpose of data collection. Data will collect through using the questionnaire that consisted of the following parts: Baseline characteristics of the study participants. such as (name, age, sex, marital status, level of education, occupation, mobile number, body mass index), and theory of planned behavior will construct (TPB) who will receive nutritional education intervention, for a NAFLD diagnosis, ultrasound proof of fatty liver (stage I or above) and biochemical parameter such as an elevated level of liver enzymes will require. An experienced radiologist will do the ultrasonography. The grade of fatty liver will determine based on hepatic parenchymal brightness by ultrasound, and established methods will use to test the liver's biochemical parameters such as lipid profile (cholesterol LDL, cholesterol HDL, Triglycerides, and Total cholesterol). and liver AST, ALT, ALP and GGT). And measuring body mass index will be measure at the baseline and after 12-weeks of intervention among NAFLD patients who will receive either nutritional education, omega-3 supplementation and control group. The questionnaire will modify based on the literature review and feedback of experts, which is applicable and specific to the study also translated to Kurdish language.
The validity of the study:
Tools will be designed by the researcher after reviewing the relevant literature and tested for its content validity. The questionnaire will be sent to panel of experts from different health specialty (such as Community health nursing, hepatologist medicine, community medicine specialist) to assess the relevance of tool with title and objectives. The responses will be represented in four points score ranging from (4-1); 4= strongly relevant, 3= relevant, 2= little relevant, and 1= not relevant by use Liker scale.
The Reliability of the study:
Consistency of questionnaire will be tested by Cronbach's alpha test (test-re-test) reliability will be checked on that answered the questionnaire twice. A correlation analysis will be performed on the scores of the two tests (observations test and knowledge test), Test-Retest will be done by 10non alcoholic fatty liver disease patients who will not part of the samples.
Pilot study:
The pilot study will be carried out on 10 non- alcoholic fatty liver disease patients to test all tools for clarity, objectivity, relevance, feasibility and the applicability of the tools. It also will conduct to identify any problem associated with administering the tools and measure the time needed for data collection then the necessary modifications will be conducted accordingly. Data included in pilot study will be excluded from the current study.
Implementation of the interventional program:
The interventional program will focus on nutrition education and omega-3 supplementation ways, which was implemented through the sessions. The nutritional interventional program sessions were administrated individually or in small group and each session was designed and scheduled for approximately45-60 minutes.
First phase: an interview session The researcher will introduce herself to the NAFLD patients and explained the nature of the subject area to the approached ones who run across the inclusion criteria and agreed to take part in the study, then will start. The researcher will interview NAFLD patients. The NAFLD patients become aware of keeping confidentiality of information and they complete the basic information forms which will prepare by the researcher. According to Randomization criteria the NAFLD patients will be divide into two groups of intervention and one control.
Second Phase: Pre- test Pre-test assessment of each NAFLD patients in program according of each three group will expose to the pre-test questionnaire (both knowledge and lifestyle), BMI measures, Laboratory test (liver function test and lipid profile).
Third Phase: Intervention among NAFLD patients The Intervention among NAFLD patients. According to Randomization criteria the NAFLD patients will be divide into three groups, two groups of intervention and one control. In nutrition education group, will interview individually or in small groups.
Fourth Phase: Post- Test After 12 weeks of the completion, the posttest will administer to collect knowledge and changes of daily life for all NAFLD patients and referring them for ultrasound and making laboratory test liver enzyme such as (AST, ALT, ALP and GGTP) and lipid profile such as (cholesterol LDL, cholesterol HDL, Triglycerides, and Total cholesterol) in three groups will do.
- Conditions
- Non-alcoholic Fatty Liver Disease (NAFLD), Omega-3 Supplementation, Nutrition Education Program
- Being tested
- nutrition education program, Omega 3 fatty acids, control group
- Keywords
- Nutrition Education, Omega-3 Supplementation, Body Weight, Liver Enzyme, Lipid Profile, Non-alcoholic Fatty Liver Disease (NAFLD)
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition education programBehavioural
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 fatty acidsDietary supplement
Omega-3 Arm:1000 mg omega-3 fatty acids soft gel capsules twice daily, to be taken orally with meal.
control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition education Program | Active comparator | 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. Receives: Behavioral: nutrition education program |
| Omega-3 supplementation | Active comparator | 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. Receives: Dietary Supplement: Omega 3 fatty acids |
| control | Active comparator | 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. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparision the effectiveness of nutrition education and Omega-3 supplementation on reduction in hepatic steatosis scores.
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.
Measured: hepatic steatosis scores the measurement will be taken at the baseline and through study completion, an average of 12 weeks.
Comparision the effectiveness of nutrition education and Omega-3 supplementation on changes in serum concentrations of liver enzymes.
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.
Measured: liver enzymes measurement will be taken at the baseline and through study completion, an average of 12 weeks.
Comparision the effectiveness of nutrition education and Omega-3 supplementation on changes in serum concentrations of lipid profile.
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 .
Measured: lipid profile measurement will be taken at the baseline and through study completion, an average of 12 weeks.
Secondary outcomes (3)
comparison the effectiveness of nutrition education and omega-3 supplementation on changes in body weight measurements.
The first secondary outcomes were changes in body weight, among non-alcoholic fatty liver disease patients.
body weight: measures by a calibrate digital scale. will be measure barefoot and in light clothing to the nearest 0.5 kg using a reliable scale (Seca).
Measured: 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 second secondary outcomes were changes waist circumferences among non-alcoholic fatty liver disease patients.
waist circumferences: use a flexible tape measure, in which in a standing position. Wrap a tape measure around your waist - it should sit right above your hip bone. Check that the tape is parallel to the floor, forming a horizontal line across your body. The tape shouldn't press into your skin, but it should be a snug fit. Take the measurement after breathing out.
Measured: 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 third secondary outcomes will be changes in BMI measurements among non-alcoholic fatty liver disease patients.
BMI: by calculation: by Measure your weight in kilograms (kg), Measure your height in meters (m). Then divide your weight by your height squared (kg/m²).
The resulting number is your BMI.
Measured: the time frame of the BMI measurement from baseline to through study completion, an average of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start29 Oct 2024
- Primary completion3 Mar 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver Disease (NAFLD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilkhosh Shamal Ramadhan, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627114
- Sponsor's protocol ID
- Nutrition education VS Omega-3
- Status last verified
- Jun 2026
- First submitted
- 1 Oct 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arab A, Hadi A, Moosavian SP, Rafie N, Hajianfar H. The Effect of Nutrition Education Program on Overweight/Obese Patients with Non-Alcoholic Fatty Liver Disease: a Single-Blind Parallel Randomized Controlled Trial. Clin Nutr Res. 2019 Jul 29;8(3):238-246. doi: 10.7762/cnr.2019.8.3.238. eCollection 2019 Jul.
PubMed 31384602Fateh HL, Rashid SA, Muhammad SS, Al-Jaf SH, Ali AM. Comparing effects of beetroot juice and Mediterranean diet on liver enzymes and sonographic appearance in patients with non-alcoholic fatty liver disease: a randomized control trials. Front Nutr. 2023 Aug 17;10:1181706. doi: 10.3389/fnut.2023.1181706. eCollection 2023.
PubMed 37662597Yan JH, Guan BJ, Gao HY, Peng XE. Omega-3 polyunsaturated fatty acid supplementation and non-alcoholic fatty liver disease: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Sep;97(37):e12271. doi: 10.1097/MD.0000000000012271.
PubMed 30212963Angelidi AM, Papadaki A, Nolen-Doerr E, Boutari C, Mantzoros CS. The effect of dietary patterns on non-alcoholic fatty liver disease diagnosed by biopsy or magnetic resonance in adults: a systematic review of randomised controlled trials. Metabolism. 2022 Apr;129:155136. doi: 10.1016/j.metabol.2022.155136. Epub 2022 Jan 13.
PubMed 35032545Ramadhan DS, Mustafa IH. Effectiveness of nutrition education program and omega-3 supplementation on body weight, liver enzyme, lipid profile among non-alcoholic fatty liver disease patients. BMC Nutr. 2026 Apr 16;12(1):100. doi: 10.1186/s40795-026-01309-0.
PubMed 41992378
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nutrition Education Program and Omega-3 Supplementation on Body Weight, Liver Enzymes, Lipid Profile Among Non-Alcoholic Fatty Liver Disease Patients
- ClinicalTrials.gov ID
- NCT06627114
- Acronym / sponsor ID
- Nutrition education VS Omega-3
- Conditions
- Non-alcoholic Fatty Liver Disease (NAFLD), Omega-3 Supplementation, Nutrition Education Program
- Keywords
- Nutrition Education, Omega-3 Supplementation, Body Weight, Liver Enzyme, Lipid Profile, Non-alcoholic Fatty Liver Disease (NAFLD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- 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.
Tools for data collection The questionnaire that will be developed for the purpose of data collection. Data will collect through using the questionnaire that consisted of the following parts: Baseline characteristics of the study participants. such as (name, age, sex, marital status, level of education, occupation, mobile number, body mass index), and theory of planned behavior will construct (TPB) who will receive nutritional education intervention, for a NAFLD diagnosis, ultrasound proof of fatty liver (stage I or above) and biochemical parameter such as an elevated level of liver enzymes will require. An experienced radiologist will do the ultrasonography. The grade of fatty liver will determine based on hepatic parenchymal brightness by ultrasound, and established methods will use to test the liver's biochemical parameters such as lipid profile (cholesterol LDL, cholesterol HDL, Triglycerides, and Total cholesterol). and liver AST, ALT, ALP and GGT). And measuring body mass index will be measure at the baseline and after 12-weeks of intervention among NAFLD patients who will receive either nutritional education, omega-3 supplementation and control group. The questionnaire will modify based on the literature review and feedback of experts, which is applicable and specific to the study also translated to Kurdish language.
The validity of the study:
Tools will be designed by the researcher after reviewing the relevant literature and tested for its content validity. The questionnaire will be sent to panel of experts from different health specialty (such as Community health nursing, hepatologist medicine, community medicine specialist) to assess the relevance of tool with title and objectives. The responses will be represented in four points score ranging from (4-1); 4= strongly relevant, 3= relevant, 2= little relevant, and 1= not relevant by use Liker scale.
The Reliability of the study:
Consistency of questionnaire will be tested by Cronbach's alpha test (test-re-test) reliability will be checked on that answered the questionnaire twice. A correlation analysis will be performed on the scores of the two tests (observations test and knowledge test), Test-Retest will be done by 10non alcoholic fatty liver disease patients who will not part of the samples.
Pilot study:
The pilot study will be carried out on 10 non- alcoholic fatty liver disease patients to test all tools for clarity, objectivity, relevance, feasibility and the applicability of the tools. It also will conduct to identify any problem associated with administering the tools and measure the time needed for data collection then the necessary modifications will be conducted accordingly. Data included in pilot study will be excluded from the current study.
Implementation of the interventional program:
The interventional program will focus on nutrition education and omega-3 supplementation ways, which was implemented through the sessions. The nutritional interventional program sessions were administrated individually or in small group and each session was designed and scheduled for approximately45-60 minutes.
First phase: an interview session The researcher will introduce herself to the NAFLD patients and explained the nature of the subject area to the approached ones who run across the inclusion criteria and agreed to take part in the study, then will start. The researcher will interview NAFLD patients. The NAFLD patients become aware of keeping confidentiality of information and they complete the basic information forms which will prepare by the researcher. According to Randomization criteria the NAFLD patients will be divide into two groups of intervention and one control.
Second Phase: Pre- test Pre-test assessment of each NAFLD patients in program according of each three group will expose to the pre-test questionnaire (both knowledge and lifestyle), BMI measures, Laboratory test (liver function test and lipid profile).
Third Phase: Intervention among NAFLD patients The Intervention among NAFLD patients. According to Randomization criteria the NAFLD patients will be divide into three groups, two groups of intervention and one control. In nutrition education group, will interview individually or in small groups.
Fourth Phase: Post- Test After 12 weeks of the completion, the posttest will administer to collect knowledge and changes of daily life for all NAFLD patients and referring them for ultrasound and making laboratory test liver enzyme such as (AST, ALT, ALP and GGTP) and lipid profile such as (cholesterol LDL, cholesterol HDL, Triglycerides, and Total cholesterol) in three groups will do.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nutrition education Program | Active comparator | Behavioral: nutrition education programpatients 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 supplementation | Active comparator | Dietary Supplement: Omega 3 fatty acidsOmega-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. |
| control | Active comparator | Other: control groupPatients 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutrition education programNutritional 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. | Behavioural | Nutrition education Program |
| Omega 3 fatty acidsOmega-3 Arm:1000 mg omega-3 fatty acids soft gel capsules twice daily, to be taken orally with meal. | Dietary supplement | Omega-3 supplementation |
| control groupreceive 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. | Other | control |
Primary outcome
Comparision the effectiveness of nutrition education and Omega-3 supplementation on reduction in hepatic steatosis scores.
Time frame: 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.
Time frame: 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.
Time frame: 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 .
3 secondary outcomes
comparison the effectiveness of nutrition education and omega-3 supplementation on changes in body weight measurements.
Time frame: 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.
Time frame: 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.
Time frame: the time frame of the BMI measurement from baseline to through study completion, an average of 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Results publication: PubMed 31384602Arab A, Hadi A, Moosavian SP, Rafie N, Hajianfar H. The Effect of Nutrition Education Program on Overweight/Obese Patients with Non-Alcoholic Fatty Liver Disease: a Single-Blind Parallel Randomized Controlled Trial. Clin Nutr Res. 2019 Jul 29;8(3):238-246. doi: 10.7762/cnr.2019.8.3.238. eCollection 2019 Jul.
- Results publication: PubMed 37662597Fateh HL, Rashid SA, Muhammad SS, Al-Jaf SH, Ali AM. Comparing effects of beetroot juice and Mediterranean diet on liver enzymes and sonographic appearance in patients with non-alcoholic fatty liver disease: a randomized control trials. Front Nutr. 2023 Aug 17;10:1181706. doi: 10.3389/fnut.2023.1181706. eCollection 2023.
- Results publication: PubMed 30212963Yan JH, Guan BJ, Gao HY, Peng XE. Omega-3 polyunsaturated fatty acid supplementation and non-alcoholic fatty liver disease: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Sep;97(37):e12271. doi: 10.1097/MD.0000000000012271.
- Results publication: PubMed 35032545Angelidi AM, Papadaki A, Nolen-Doerr E, Boutari C, Mantzoros CS. The effect of dietary patterns on non-alcoholic fatty liver disease diagnosed by biopsy or magnetic resonance in adults: a systematic review of randomised controlled trials. Metabolism. 2022 Apr;129:155136. doi: 10.1016/j.metabol.2022.155136. Epub 2022 Jan 13.
- Derived from this study: PubMed 41992378Ramadhan DS, Mustafa IH. Effectiveness of nutrition education program and omega-3 supplementation on body weight, liver enzyme, lipid profile among non-alcoholic fatty liver disease patients. BMC Nutr. 2026 Apr 16;12(1):100. doi: 10.1186/s40795-026-01309-0.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition education program and Omega 3 fatty acids in people with Non-alcoholic Fatty Liver Disease (NAFLD) and Omega-3 Supplementation, run by Hawler Medical University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparision the effectiveness of nutrition education and Omega-3 supplementation on reduction in hepatic steatosis scores. (time frame: hepatic steatosis scores the measurement will be taken at the baseline and through study completion, an average of 12 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06627114, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.