Clinical trial NCT06627114: Effectiveness of Nutrition Education Program and Omega-3 Supplementation Among Non-alcoholic Fatty Liver Disease Patients
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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)
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

1. 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).
2. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Comparision the effectiveness of nutrition education and Omega-3 supplementation on reduction in hepatic steatosis scores.
timeFrame: hepatic steatosis scores the measurement will be taken at the baseline and through study completion, an average of 12 weeks.
measure: Comparision the effectiveness of nutrition education and Omega-3 supplementation on changes in serum concentrations of liver enzymes.
timeFrame: liver enzymes measurement will be taken at the baseline and through study completion, an average of 12 weeks.
measure: Comparision the effectiveness of nutrition education and Omega-3 supplementation on changes in serum concentrations of lipid profile.
timeFrame: lipid profile measurement will be taken at the baseline and through study completion, an average of 12 weeks.
Secondary outcomes:
measure: comparison the effectiveness of nutrition education and omega-3 supplementation on changes in body weight measurements.
timeFrame: the time frame of the body weight measurement from baseline to through study completion, an average of 12 weeks.
measure: comparison the effectiveness of nutrition education and omega-3 supplementation on changes in waist circumference measurements.
timeFrame: the time frame of the waist circumference measurement from baseline to through study completion, an average of 12 weeks.
measure: comparison the effectiveness of nutrition education and omega-3 supplementation on changes in Body mass index measurements.
timeFrame: the time frame of the BMI measurement from baseline to through study completion, an average of 12 weeks.
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Hawler Medical University
state: Kurdistan Region
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.