Clinical trial NCT04450875: Efficacy of Nutritional Therapy With High Methionine Content in the Treatment of NAFLD
Official title: Efficacy of Nutritional Therapy With High Methionine Content in the Treatment of Non-alcoholic Fatty Liver: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)
Keywords: Non-alcoholic Fatty Liver Disease
Nutrition Therapy
Randomized Controlled Trials
Lead sponsor: Universidad Veracruzana
Sponsor class: OTHER
Collaborators: name: National Council of Science and Technology, Mexico
name: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
First posted: 2020-06-30
Enrollment: 121
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group: It consisted of a nutritional therapy administration of foods with a high content of methionine according to the National Nutrient Database For Standard Reference (USDA) and adapted to the consumption and usual cost in the Mexican diet. The supervision of the nutritional therapy was carried out through 24-hour reminders, where each patient wrote down the amount and food consumed described in the diet during a 3-month follow-up period. Because the daily requirement for methionine for adults is 260 to 700 mg 98, patients were instructed to combine the foods until they reached a daily intake of at least 700 mg of methionine. Two nutritionists performed both diet instruction and 24-hour reminder monitoring monthly. At the end of the three-month follow-up, the 24-hour reminder data such as food consumed, daily rations, and the monthly average of milligrams of consumed methionine contained in the food, were recorded in a database for subsequent analysis.
Primary purpose: TREATMENT

Brief summary: To assess the effect of a methionine metabolism-based dietary strategy in patients with non-alcoholic fatty liver disease in order to reduce complications while improving the quality of life for patients.

Detailed description: A randomized controlled clinical trial with parallel design was performed, a ratio of at least one patient in the control group for each subject in the experimental group.

Eligibility criteria: Inclusion Criteria:

• Diagnosis of Non-alcoholic Fatty Liver Disease by biochemical parameters used by the SteatoTest and Fatty Liver Index (IHG), greater than 60 points on the scale and confirmed by liver ultrasound

Exclusion Criteria:

• Previous diagnosis of cirrhosis, hepatocarcinoma, Wilson's disease, viral hepatitis B and C and neoplasms of any origin

Primary outcomes:
measure: NAFLD reversal
timeFrame: Three months
Secondary outcomes:
measure: The Short Form (36) Health Survey (SF-36).
timeFrame: Three months
Other outcomes:
measure: ALT (Level of liver damage enzymes)
timeFrame: Three months
measure: AST (Level of liver damage enzymes)
timeFrame: Three months
measure: GGT(Level of liver damage enzymes)
timeFrame: Three months
measure: Glucose
timeFrame: Three months
measure: Triglycerides
timeFrame: Three months
measure: Cholesterol
timeFrame: Three months
measure: Weight
timeFrame: Three months
measure: Height Height
timeFrame: Three months
measure: Body mass index (BMI)
timeFrame: Three months
measure: Waist
timeFrame: Three months
measure: Hip
timeFrame: Three months
measure: Waist-hip ratio
timeFrame: Three months
measure: Systolic BP
timeFrame: Three months
measure: Diastolic BP
timeFrame: Three months
Locations:
city: Xalapa
country: Mexico
facility: Rebeca García Román
state: Veracruz
Study officials:
affiliation: UV
name: Rebeca García Román, PHD
role: PRINCIPAL_INVESTIGATOR
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