Effectiveness of Nutrition Education Program and Omega-3 Supplementation Among Non-alcoholic Fatty Liver Disease Patients

NCT06627114 | Not Yet Recruiting DMC

• 1 other identifier: Nutrition education VS Omega-3
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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.

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)

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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 .

  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 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.

Study Arms (3)

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.

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.

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.

Other: control group

Interventions

nutrition education program BEHAVIORAL

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.

Nutrition education Program

Omega 3 fatty acids DIETARY_SUPPLEMENT

Omega-3 Arm:1000 mg omega-3 fatty acids soft gel capsules twice daily, to be taken orally with meal.

Omega-3 supplementation

control group OTHER

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.

control

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Hawler Medical University

Erbil, Kurdistan Region, 44001, Iraq

Location

Related Publications (4)

• 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.

  PMID: 31384602 BACKGROUND

• Fateh 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.

  PMID: 37662597 BACKGROUND

• Yan 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.

  PMID: 30212963 BACKGROUND

• Angelidi 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.

  PMID: 35032545 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Body Weight

Interventions

Fatty Acids, Omega-3; Control Groups

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Dilkhosh Shamal Ramadhan, Master degree

CONTACT

Iraq +9647504197868; dilkhosh.ramadhan@hmu.edu.krd

Ibrahim Hassan Mustafa, doctorate

CONTACT

Iraq +9647504775336; Ibrahim.mustafa.@hmu.edu.krd

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 4, 2024
• Study Start: November 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)