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

Not Applicable

Completed

• Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)
• Interventions: Dietary Supplement: Experimental group (with diet)

• Registration Number: NCT04450875
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2015-03-24
• Primary Completion: 2016-02-01
• Study Completion: 2017-11-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-24
• Last Update Submitted: 2020-06-24
• Study First Posted: 2020-06-30
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group (with diet)	Experimental group (with diet)	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.

Primary Outcome Measures

Name	Time	Method
NAFLD reversal	Three months	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

Secondary Outcome Measures

Name	Time	Method
The Short Form (36) Health Survey (SF-36).	Three months	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. .This questionnaire has been adapted to the Mexican population

Trial Locations

Locations (1)

Rebeca García Román; 🇲🇽 Xalapa, Veracruz, Mexico