Health Trials

The Effects of 5-methyltetrahydrofolate Supplementation in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease

ConditionsNonalcoholic Fatty Liver DiseaseNonalcoholic Fatty Liver Disease (NAFLD)MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseMASLDNAFLDMetabolic Dysfunction-Associated Steatotic Liver DiseaseNAFLD (Nonalcoholic Fatty Liver Disease)NAFLD (Non-alcoholic Fatty Liver Disease)NAFLD - Non-Alcoholic Fatty Liver DiseaseNAFLD - Nonalcoholic Fatty Liver Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorTabriz University of Medical Sciences

About this trial

To determine the effect of MTHF supplementation on serum folate and homocysteine level, metabolic, nutritional status, liver function, and PPARα and TNFα gene expression in patients with MASLD

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult men or women (18-50 years)

Diagnosis of MASLD (grade 1 or 2 of steatosis confirmed by ultrasound)

Body mass index (BMI) = 25-34.9 kg/m²

Providing written informed consent

Disqualifiers

Pregnancy, lactation, or plans to get pregnant during the next three months.

Liver disease (viral hepatitis, autoimmune liver disease, cirrhosis, drug-induced hepatotoxicity, or alcoholic fatty liver disease), heart or renal failure, kidney stones, any neoplasia, inflammatory disease, hypothyroidism, hypercortisolism, or hypertension

Taking drugs affecting glucose or lipid metabolism, folate supplements, anti-obesity medications, weight-loss diets, or dietary supplements

Lifestyle factors known to impact folate status (current smoking, alcohol intake, recreational drug use)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 5-methyltetrahydrofolate (5-MTHF)

    Dietary supplement

    Patients in this group will receive 5-methyltetrahydrofolate tablets (800 mcg) once a day for 90 days. Tablets will be manufactured by Ashbal Chemi pharmaceutical company (Qfol, Ashbal Chemi Co., Tehran, Iran).

  • placebo group

    Dietary supplement

    Patients in this group will receive placebo for 90 days. The placebo is corn starch/ cellulose and will be consumed once a day. Placebo tablets will be manufactured by Ashbal Chemi Co. (Tehran, Iran).

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Serum folate level

Changes in serum folate level pre and post the 3-month intervention period.

Time frame
3 months
2

Serum homocysteine level

Changes in serum homocysteine level pre and post the 3-month intervention period.

Time frame
3 months
3

Expression of PPARα and TNFα genes

Changes in expression of PPARα and TNFα genes pre and post the 3-month intervention period.

Time frame
3 months

Secondary outcomes

1

Liver biochemical parameters (ALT (alanine aminotransferase), AST (aspartate aminotransferase), and GGT (gamma-glutamyl transferase)

Changes in ALT, AST, and GGT pre and post the 3-month intervention period.

Time frame
3 months
2

The fibrosis-4 (FIB-4) index

Changes in FIB-4 index pre and post the 3-month intervention period. The Fibrosis-4 (FIB-4) index will be calculated using the following formula: FIB-4 = (Age \[years\] × AST \[U/L\]) / (Platelet count \[10⁹/L\] × √ALT \[U/L\]). FIB-4 values \>1.3, indicate a greater likelihood of liver fibrosis.

Time frame
3 months
3

Quality of life using SF-36 (36-Item Short Form Health Survey) questionnaires

Changes in quality-of-life pre and post the 3-month intervention period. Health-related quality of life will be assessed using the validated 36-Item Short Form Health Survey (SF-36). The questionnaire evaluates eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores for each domain will be transformed to a 0-100 scale according to the standard scoring algorithm, with higher scores indicating better health-related quality of life.

Time frame
3 months
4

Lipid profile (triglycerides, total cholesterol, LDL-C (low-density lipoprotein cholesterol), HDL-C (high-density lipoprotein cholesterol))

Changes in lipid profile (triglycerides, total cholesterol, LDL-C, HDL-C) pre and post the 3-month intervention period.

Time frame
3 monhs

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tabriz University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: