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

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

Treatments tested in this trial

  • 5-methyltetrahydrofolate (5-MTHF)
  • placebo group

Treatment groups

44 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Tabriz University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov