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NCT Number: NCT04450875

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

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease (NAFLD) Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rebeca García Román

Xalapa, Veracruz, 91190, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Weight

    Time frame: Three months

    Measurement in kilograms

  8. Height Height

    Time frame: Three months

    Measurement in meters

  9. 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.

  10. Waist

    Time frame: Three months

    Measurement in centimeters

  11. Hip

    Time frame: Three months

    Measurement in centimeters

  12. 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.

  13. Systolic BP

    Time frame: Three months

    Report SBP in mmHg, will be assessed during the study period

  14. Diastolic BP

    Time frame: Three months

    Report DBP in mmHg, will be assessed during the study period

Sponsors and collaborators

Lead sponsor

Universidad Veracruzana

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 30, 2020
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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