Non-alcoholic Fatty Liver Disease (NAFLD)
Conditions
Keywords
Non-alcoholic Fatty Liver Disease, Nutrition Therapy, Randomized Controlled Trials
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.
Interventions
DIETARY_SUPPLEMENTExperimental 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.
Sponsors
National Council of Science and Technology, Mexico
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Universidad Veracruzana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| GGT(Level of liver damage enzymes) | 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. |
| Glucose | Three months | Elevated fasting glucose ≥ 100 mg/dl. It will be expressed as mean and standard deviation and will be compared in both groups. |
| Triglycerides | 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. |
| Cholesterol | 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. |
| Weight | Three months | Measurement in kilograms |
| Height Height | Three months | Measurement in meters |
| ALT (Level of liver damage enzymes) | 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. |
| Waist | Three months | Measurement in centimeters |
| Hip | Three months | Measurement in centimeters |
| Waist-hip ratio | 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. |
| Systolic BP | Three months | Report SBP in mmHg, will be assessed during the study period |
| Diastolic BP | Three months | Report DBP in mmHg, will be assessed during the study period |
| Body mass index (BMI) | 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. |
| AST (Level of liver damage enzymes) | 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 |
Countries
Mexico
Outcome results
None listed