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

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ClinicalTrials.gov Identifier: NCT04450875
Recruitment Status : Completed
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborators:
National Council of Science and Technology, Mexico
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Information provided by (Responsible Party):
María Cristina León, 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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease (NAFLD) Dietary Supplement: Experimental group (with diet) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
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.
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.
Primary Purpose: Treatment
Official Title: Efficacy of Nutritional Therapy With High Methionine Content in the Treatment of Non-alcoholic Fatty Liver: a Randomized Clinical Trial
Actual Study Start Date : March 24, 2015
Actual Primary Completion Date : February 1, 2016
Actual Study Completion Date : November 1, 2017


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.
Dietary Supplement: Experimental group (with 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Balanced groups were produced based on the sex of the study subjects, that is, men and women were proportionally assigned in both groups.
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450875


Locations
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Mexico
Rebeca García Román
Xalapa, Veracruz, Mexico, 91190
Sponsors and Collaborators
Universidad Veracruzana
National Council of Science and Technology, Mexico
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Investigators
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Principal Investigator: Rebeca García Román, PHD UV
Publications of Results:

Other Publications:
European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. J Hepatol. 2016 Jun;64(6):1388-402. doi: 10.1016/j.jhep.2015.11.004. Epub 2016 Apr 7. PubMed 27062661

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Responsible Party: María Cristina León, Investigator, Universidad Veracruzana
ClinicalTrials.gov Identifier: NCT04450875    
Other Study ID Numbers: ISP-CI-003/2014
001/060/0194 ( Other Identifier: ISSSTE )
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by María Cristina León, Universidad Veracruzana:
Non-alcoholic Fatty Liver Disease
Nutrition Therapy
Randomized Controlled Trials
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases