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

June 24, 2020 updated by: María Cristina León, Universidad Veracruzana

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Veracruz
      • Xalapa, Veracruz, Mexico, 91190
        • Rebeca García Román

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Control
The control group continued with their usual diet for the same period of 3 months as the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NAFLD reversal
Time Frame: 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
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Short Form (36) Health Survey (SF-36).
Time Frame: 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
Three months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
ALT (Level of liver damage enzymes)
Time Frame: Three months
Alanine aminotransferase (ALT) High levels (>50) indicate damage to liver cells. It will be expressed as mean and standard deviation and will be compared in both groups.
Three months
AST (Level of liver damage enzymes)
Time Frame: Three months

A high result on an AST test might indicate a problem with the liver or muscles. It will be expressed as mean and standard deviation and will be compared in both groups.

The normal range for AST is typically up to 40 IU/L

Three months
GGT(Level of liver damage enzymes)
Time Frame: Three months
High levels of GGT in the blood could indicate that the enzyme is leaking out of the liver cells and into the blood, suggesting damage to the liver or bile ducts. A typical range for GGT levels in adults is between 0 and 30 international units per liter (IU/L). It will be expressed as mean and standard deviation and will be compared in both groups.
Three months
Glucose
Time Frame: Three months
Elevated fasting glucose ≥ 100 mg/dl. It will be expressed as mean and standard deviation and will be compared in both groups.
Three months
Triglycerides
Time Frame: Three months
Elevated triglycerides ≥150 mg/dL (1.7 mmol/L). It will be expressed as mean and standard deviation and will be compared in both groups.
Three months
Cholesterol
Time Frame: Three months
Reduced HDL colesterol <40 mg/dL (1.03 mmol/L) in men <50 mg/dL (1.3 mmol/L) in women. It will be expressed as mean and standard deviation and will be compared in both groups.
Three months
Weight
Time Frame: Three months
Measurement in kilograms
Three months
Height Height
Time Frame: Three months
Measurement in meters
Three months
Body mass index (BMI)
Time Frame: Three months
Weight and height will be combined to report BMI in kg/m^2. It will be expressed as mean and standard deviation and will be compared in both groups.
Three months
Waist
Time Frame: Three months
Measurement in centimeters
Three months
Hip
Time Frame: Three months
Measurement in centimeters
Three months
Waist-hip ratio
Time Frame: Three months
Wast and hip will be combined to report WHR in cm. It will be expressed as mean and standard deviation and will be compared in both groups.
Three months
Systolic BP
Time Frame: Three months
Report SBP in mmHg, will be assessed during the study period
Three months
Diastolic BP
Time Frame: Three months
Report DBP in mmHg, will be assessed during the study period
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

June 19, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 24, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • ISP-CI-003/2014
  • 001/060/0194 (Other Identifier: ISSSTE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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