Essential Phospholipid in Metabolic Associated Fatty Liver DiseaseEssenMAFLDNCT07194863
Efficacy of Essential Phospholipid Versus Betaine HCL/L-Glutamic Acid in MAFLD
An observational study of Essential Phospholipid in Metabolic Associated Fatty Liver Disease, run by Assiut University at 1 site in Egypt.
Trial summary
To evaluate the efficacy of Essential phospholipid versus Betaine HCL/L-Glutamic Acid in MAFLD Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Phospholipid in Metabolic Associated Fatty Liver Disease
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Oct 2026
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * After obtaining the appropriate consents, data pertaining to clinical history (name, age, sex, residence, occupation, co-morbidities… diabetes, hyperlipidemia, hypertension, ischemic heart disease, special habits; such as alcohol intake). * Imaging techniques, such as ultrasonography (US), fibroscan with CAP and/or computed topography (CT) and /or MRI. * Blood samples will be collected for liver function tests (albumin, alanine aminotransferase [ALT], aspartate aminotransferase [AST], blood sugar, gamma-glutamyl transpeptidase, total bilirubin), lipid profile (total cholesterol, triglyceride, LDL) and CRP. * Six measurements will be obtained (sex, age, height, weight, body mass index, and abdominal girth, waist circumference). Calculation of fatty liver index, (FLI) will be done. The fatty liver index (FLI), is an algorithm based on waist circumference, body mass index (BMI), triglyceride, and gamma-glutamyl-transferase (GGT). Score varies from zero to100.
Who may be able to join
- All patients aged >18 years old
- diagnosed as fatty liver based on clinical examination, laboratory investigations and imaging techniques.
Who cannot join
- Patients aged ≤18 years old.
- Pregnancy.
- Presence of malignancy.
- Type I DM.
- Fatty liver patients on treatment by statin derivatives or other medications.
- Fatty liver patients undergone bariatric surgeries
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the efficacy of Essential phospholipid versus Betaine HCL/L-Glutamic Acid in MAFLD
Read the detailed description
The prevalence of non-alcoholic fatty liver disease (NAFLD) increases rapidly in recent decades. NAFLD has become a major public health problem in the whole world, and it is considered as the main cause for the chronic liver diseases (Egyptian study was done and recently published an international expert consensus statement about a new definition of metabolic dysfunction-associated fatty liver disease (MAFLD) to replace non-alcoholic fatty liver disease (NAFLD). The new nomenclature of MAFLD is based on the presence of steatosis in >5% of hepatocytes and the absence of excessive alcohol consumption or other causes of chronic liver disease, diagnosis of MAFLD could be established on the presence of hepatic steatosis in combination with one of the following three criteria: overweight/obesity; presence of type 2 diabetes mellitus; or evidence of metabolic dysregulation . Metabolic dysregulation is defined as having at least 2 of the following metabolic risk abnormalities: high waist circumference, high blood pressure, high cholesterol, pre-diabetes, insulin resistance, and high plasma C-reactive protein levels (2).New diagnostic criteria for MAFLD were proposed, in which hepatic steatosis (HS) detected either by imaging techniques, blood biomarkers/scores or by liver histology.On the other hand, NAFLD is commonly associated with one or more component of metabolic syndrome such as obesity, diabetes mellitus, and dyslipidemia and is defined as the presence of ≥ 5% hepatic steatosis in histological examination without evidence of hepatocellular injury such as hepatocyte ballooning (5).Around 20% of patients with NAFLD develop non-alcoholic steatohepatitis (NASH) which may progress to cirrhosis, however the most common cause of death in NAFLD patients is cardiovascular disease, and NAFLD is the third most common cause of hepatocellular carcinoma.The spectrum of NAFLD ranges from simple fatty liver with little inflammation to non-alcoholic steatohepatitis (NASH) with liver inflammation and fibrosis. The global prevalence of NAFLD is about 25.2% whereas the limited number of studies from Africa reports 13%."Burned out" NAFLD can be a hidden cause of cryptogenic cirrhosis. So, early diagnosis, and treatment of NAFLD and underlying predisposing factors are important to avoid liver damage which may progress to liver cell failure. NAFLD is strongly associated with MS and is currently considered as the hepatic manifestation of MS. In addition, obesity is a common risk factor for NAFLD. Essential phospholipids (EPLs) are naturally occurring hepatoprotective agents that have been used in the management of NAFLD. EPLs are obtained from soybeans, and their main component is phosphatidylcholine. EPLs improved liver steatosis in patients with NAFLD in a number of randomized controlled clinical trials, including placebo-controlled studies. The Russian guidelines for the diagnosis and management of NAFLD recommend EPLs as an adjunctive therapy for the management of NAFLD.
Subjective self-assessed parameters are measured in observational studies, usually without objective endpoints. NAFLD is almost always asymptomatic, so it is interesting that subjective feelings are a reliable indicator of objective disease severity. EPLs have been associated with subjective improvements, treatment satisfaction, and high adherence ; however, to date, no studies have analyzed whether subjective improvement, satisfaction with treatment, and adherence to treatment are associated with objective changes in liver structure or function. Mitochondrial dysfunction increases DNA methylation, which can cause the development of metabolic syndrome in obesity and the progression of NAFLD. Therefore, the regulation of DNA methylation could prevent NAFLD by attenuating mitochondrial dysfunction. DNA cytosine-5-methyltransferases (DNMTs) mediate DNA methylation by catalysing the transfer of the methyl group from SAM to cytosine during DNA replication. Betaine supplementation significantly elevates DNMT at the mRNA level in animals. The epigenetic effects of SAM via DNA methylation are driven by SAM precursors such as betaine and Met. Betaine acts as a methyl donor for DNA methylation in epigenetic regulation and provides a methyl group to participatein one-carbon metabolism to promote SAM formation. Recent research reported that access to 1% betaine-supplemented water for a total of 8 weeks alters the methylation status of specific gene promoters in mice, leading to persistent changes in gene expression that could be beneficial for the treatment of obesity and type 2 diabetes owing to their valuable metabolic effects on lipolysis, the TCA cycle and mitochondrial oxidative demethylation. However, the mechanism by which betaine methylation regulates mitochondrial oxidative demethylation to ameliorate NAFLD remains unclear.
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the efficacy of Essential phospholipid versus Betaine HCL/L-Glutamic Acid in MAFLD
Evaluation of the mean change in hepatic fat fraction from baseline to the end of treatment to compare the efficacy of Essential phospholipid versus Betaine HCL/L-Glutamic Acid in patients with metabolic dysfunction-associated fatty liver disease (MAFLD).
Measured: Baseline and at 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Oct 2026
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential Phospholipid in Metabolic Associated Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohammed Abdel Mowgod, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194863
- Sponsor's protocol ID
- 2025-04-300571
- Acronym
- EssenMAFLD
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Essential Phospholipid Versus Betaine HCL/L-Glutamic Acid in MAFLD
- ClinicalTrials.gov ID
- NCT07194863
- Acronym / sponsor ID
- EssenMAFLD / 2025-04-300571
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 26 Sep 2025 (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.
To evaluate the efficacy of Essential phospholipid versus Betaine HCL/L-Glutamic Acid in MAFLD
Detailed description
The prevalence of non-alcoholic fatty liver disease (NAFLD) increases rapidly in recent decades. NAFLD has become a major public health problem in the whole world, and it is considered as the main cause for the chronic liver diseases (Egyptian study was done and recently published an international expert consensus statement about a new definition of metabolic dysfunction-associated fatty liver disease (MAFLD) to replace non-alcoholic fatty liver disease (NAFLD). The new nomenclature of MAFLD is based on the presence of steatosis in >5% of hepatocytes and the absence of excessive alcohol consumption or other causes of chronic liver disease, diagnosis of MAFLD could be established on the presence of hepatic steatosis in combination with one of the following three criteria: overweight/obesity; presence of type 2 diabetes mellitus; or evidence of metabolic dysregulation . Metabolic dysregulation is defined as having at least 2 of the following metabolic risk abnormalities: high waist circumference, high blood pressure, high cholesterol, pre-diabetes, insulin resistance, and high plasma C-reactive protein levels (2).New diagnostic criteria for MAFLD were proposed, in which hepatic steatosis (HS) detected either by imaging techniques, blood biomarkers/scores or by liver histology.On the other hand, NAFLD is commonly associated with one or more component of metabolic syndrome such as obesity, diabetes mellitus, and dyslipidemia and is defined as the presence of ≥ 5% hepatic steatosis in histological examination without evidence of hepatocellular injury such as hepatocyte ballooning (5).Around 20% of patients with NAFLD develop non-alcoholic steatohepatitis (NASH) which may progress to cirrhosis, however the most common cause of death in NAFLD patients is cardiovascular disease, and NAFLD is the third most common cause of hepatocellular carcinoma.The spectrum of NAFLD ranges from simple fatty liver with little inflammation to non-alcoholic steatohepatitis (NASH) with liver inflammation and fibrosis. The global prevalence of NAFLD is about 25.2% whereas the limited number of studies from Africa reports 13%."Burned out" NAFLD can be a hidden cause of cryptogenic cirrhosis. So, early diagnosis, and treatment of NAFLD and underlying predisposing factors are important to avoid liver damage which may progress to liver cell failure. NAFLD is strongly associated with MS and is currently considered as the hepatic manifestation of MS. In addition, obesity is a common risk factor for NAFLD. Essential phospholipids (EPLs) are naturally occurring hepatoprotective agents that have been used in the management of NAFLD. EPLs are obtained from soybeans, and their main component is phosphatidylcholine. EPLs improved liver steatosis in patients with NAFLD in a number of randomized controlled clinical trials, including placebo-controlled studies. The Russian guidelines for the diagnosis and management of NAFLD recommend EPLs as an adjunctive therapy for the management of NAFLD.
Subjective self-assessed parameters are measured in observational studies, usually without objective endpoints. NAFLD is almost always asymptomatic, so it is interesting that subjective feelings are a reliable indicator of objective disease severity. EPLs have been associated with subjective improvements, treatment satisfaction, and high adherence ; however, to date, no studies have analyzed whether subjective improvement, satisfaction with treatment, and adherence to treatment are associated with objective changes in liver structure or function. Mitochondrial dysfunction increases DNA methylation, which can cause the development of metabolic syndrome in obesity and the progression of NAFLD. Therefore, the regulation of DNA methylation could prevent NAFLD by attenuating mitochondrial dysfunction. DNA cytosine-5-methyltransferases (DNMTs) mediate DNA methylation by catalysing the transfer of the methyl group from SAM to cytosine during DNA replication. Betaine supplementation significantly elevates DNMT at the mRNA level in animals. The epigenetic effects of SAM via DNA methylation are driven by SAM precursors such as betaine and Met. Betaine acts as a methyl donor for DNA methylation in epigenetic regulation and provides a methyl group to participatein one-carbon metabolism to promote SAM formation. Recent research reported that access to 1% betaine-supplemented water for a total of 8 weeks alters the methylation status of specific gene promoters in mice, leading to persistent changes in gene expression that could be beneficial for the treatment of obesity and type 2 diabetes owing to their valuable metabolic effects on lipolysis, the TCA cycle and mitochondrial oxidative demethylation. However, the mechanism by which betaine methylation regulates mitochondrial oxidative demethylation to ameliorate NAFLD remains unclear.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * After obtaining the appropriate consents, data pertaining to clinical history (name, age, sex, residence, occupation, co-morbidities… diabetes, hyperlipidemia, hypertension, ischemic heart disease, special habits; such as alcohol intake). * Imaging techniques, such as ultrasonography (US), fibroscan with CAP and/or computed topography (CT) and /or MRI. * Blood samples will be collected for liver function tests (albumin, alanine aminotransferase [ALT], aspartate aminotransferase [AST], blood sugar, gamma-glutamyl transpeptidase, total bilirubin), lipid profile (total cholesterol, triglyceride, LDL) and CRP. * Six measurements will be obtained (sex, age, height, weight, body mass index, and abdominal girth, waist circumference). Calculation of fatty liver index, (FLI) will be done. The fatty liver index (FLI), is an algorithm based on waist circumference, body mass index (BMI), triglyceride, and gamma-glutamyl-transferase (GGT). Score varies from zero to100.
Key inclusion criteria (2 listed)
- All patients aged >18 years old
- diagnosed as fatty liver based on clinical examination, laboratory investigations and imaging techniques.
Key exclusion criteria (6 listed)
- Patients aged ≤18 years old.
- Pregnancy.
- Presence of malignancy.
- Type I DM.
- Fatty liver patients on treatment by statin derivatives or other medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluate the efficacy of Essential phospholipid versus Betaine HCL/L-Glutamic Acid in MAFLD
Time frame: Baseline and at 12 weeks of treatment
Evaluation of the mean change in hepatic fat fraction from baseline to the end of treatment to compare the efficacy of Essential phospholipid versus Betaine HCL/L-Glutamic Acid in patients with metabolic dysfunction-associated fatty liver disease (MAFLD).
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 5 Nov 2026.
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?
An observational study of Essential Phospholipid in Metabolic Associated Fatty Liver Disease, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 6 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 5 Nov 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 Egypt. 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?
evaluate the efficacy of Essential phospholipid versus Betaine HCL/L-Glutamic Acid in MAFLD (time frame: Baseline and at 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.