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

NCT04450875 | Completed DMC

• 2 other identifiers: ISP-CI-003/2014001/060/0194
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)

Keywords

Non-alcoholic Fatty Liver Disease; Nutrition Therapy; Randomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

• NAFLD reversal

  Change in FLI to a level less than 60 points at the end of the dietary intervention. FLI was the result of the algorithm based on waist circumference, body mass index, serum GGT level and triglycerides. Bedogni, et al developed this fatty liver prediction model. The total possible score ranges from 1 to 100 points, where a score greater than or equal to 60 is considered to be NAFLD probable, and a level below 30 points is considered normal

  Three months

Secondary Outcomes (1)

• The Short Form (36) Health Survey (SF-36).

  Three months

Other Outcomes (14)

• ALT (Level of liver damage enzymes)

  Three months

• AST (Level of liver damage enzymes)

  Three months

• GGT(Level of liver damage enzymes)

  Three months

Study Arms (2)

Experimental group (with diet)

EXPERIMENTAL

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.

Dietary Supplement: Experimental group (with diet)

Control

NO INTERVENTION

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

Interventions

Experimental group (with diet) DIETARY_SUPPLEMENT

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.

Experimental group (with diet)

Eligibility Criteria

• Age: 20 Years - 99 Years
• Gender Eligibility Details: Balanced groups were produced based on the sex of the study subjects, that is, men and women were proportionally assigned in both groups.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Veracruzana: lead
• National Council of Science and Technology, Mexico: collaborator
• Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado: collaborator

Study Sites (1)

Rebeca García Román

Xalapa, Veracruz, 91190, Mexico

Location

Related Publications (33)

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MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Rebeca García Román, PHD

  UV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 30, 2020
• Study Start: March 24, 2015
• Primary Completion: February 1, 2016
• Study Completion: November 1, 2017
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)