Efficacy of Nutritional Therapy With High Methionine Content in the Treatment of NAFLD

Efficacy of Nutritional Therapy With High Methionine Content in the Treatment of Non-alcoholic Fatty Liver: a Randomized Clinical Trial

Sponsors

Lead Sponsor: Universidad Veracruzana

Collaborator: National Council of Science and Technology, Mexico
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Source Universidad Veracruzana
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.

Overall Status Completed
Start Date March 24, 2015
Completion Date November 1, 2017
Primary Completion Date February 1, 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
NAFLD reversal Three months
Secondary Outcome
Measure Time Frame
The Short Form (36) Health Survey (SF-36). Three months
Enrollment 121
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Experimental group (with diet)

Description: 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.

Arm Group Label: Experimental group (with diet)

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

Gender: All

Gender Based: Yes

Gender Description: Balanced groups were produced based on the sex of the study subjects, that is, men and women were proportionally assigned in both groups.

Minimum Age: 20 Years

Maximum Age: 99 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Rebeca García Román, PHD Principal Investigator UV
Location
Facility: Rebeca García Román
Location Countries

Mexico

Verification Date

June 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Universidad Veracruzana

Investigator Full Name: María Cristina León

Investigator Title: Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Experimental group (with diet)

Type: Experimental

Description: It consisted in the administration of nutritional therapy with foods high in methionine according to the National Nutrient Database For Standard Reference (USDA) and adapted to the consumption and usual cost in the Mexican diet.

Label: Control

Type: No Intervention

Description: The control group continued with their usual diet for the same period of 3 months as the experimental group.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

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

Masking: Double (Participant, Outcomes Assessor)

Masking Description: Balanced groups are produced on the computer-generated random numbers based on the sex of the study subjects, that is, men and women were proportionally assigned in both groups. An investigator from outside the allocation of exposure generated the random numbers in four blocks: 1) men assigned to the experimental group, 2) women assigned to the experimental group, 3) men assigned to the control group and 4) women assigned to the control group. A second investigator, blindly assigned subjects to experimental and control group. Although concealment of allocation to interest groups could be confirmed, masking of difficulties was not possible once the follow-up began.

Source: ClinicalTrials.gov