Insulin-resistant subjects with and without a diagnosis of non-alcoholic fatty liver disease (NAFLD) Digestive System
Conditions
Interventions
The randomization sequence was generated by a statistician using STATA 16 software (Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC), and subjects were assigned to each of t
Group B: subjects with MS and NAFLD.
The experimental groups will be the following:
GROUP A1 (22 subjects): subjects with MS who will have to follow the isocaloric diet (MS control group)
GROUP A2 (22 subjects): subjects with MS who will have to take one Golden Delicious Apple DOP per day in combination with an isocalor
Sponsors
Consorzio Melinda SCA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects of both sexes who have the following characteristics will be included in the study: 1. Between the ages of 18 and 75 2. Able to understand and sign the informed consent 3. Able to understand and comply with the requirements of the protocol 4. Negative HIV test 5. Negative pregnancy test 6. Diagnosis of MS (and therefore have at least three of the following risk factors: 6.1. Abdominal circumference = 80 cm (women) = 94 cm (men) 6.2. Triglycerides = 150 mg/dl; HDL < 40 mg/dl (men); HDL < 50 mg/dl (women) 6.3. Fasting blood glucose = 100 mg/dl 6.4. Blood pressure = 130/85 mmHg 7. Diagnosis of NAFLD in the last 12 months before the t0 visit (if belonging to group b); the diagnosis must have been confirmed by a diagnostic imaging investigation: ultrasound and/or CT scan and/or magnetic resonance imaging of the liver 8. Who are not taking and are not taking drugs, including antidiabetics, drugs that act on the nervous system, such as antidepressants, anxiolytics, opiates 9. Who are not taking antibiotics or have not taken antibiotics in the last four weeks, or in the last 6 months, based on the intensity and duration of antibiotic treatment
Exclusion criteria
Exclusion criteria: Subjects who have the following characteristics will be excluded from the study: 1. With the age 75 years 2. Who do not have a diagnosis of MS 3. Who do not have NAFLD (relative to group B) 4. Who have NAFLD (relative to group A) 5. Who have type 1 diabetes mellitus 6. Who has had liver diseases (cirrhosis, liver failure and hepatocarcinoma) 7. Who do not show a propensity to collaborate 8. Who have difficulty in going to the reference facility on time 9. Who are not considered suitable by the investigator due to the presence of other pathologies considered incompatible with enrollment and requiring pharmacological treatments (e.g. Active systemic diseases, diabetes, neurological and psychiatric diseases, including cognitive disorders that prevent the completion of questionnaires) 10. Suffering from HIV-acquired immunodeficiency 11. Pregnant or breastfeeding women 12. Individuals with severe visual and hearing impairments 13. With known allergies to the experimental products 14. Who use food supplements or drugs that affect lipid or carbohydrate metabolism 15. Who consume alcohol in quantities greater than 30g/day for men and 20g/day for women 16. Who use drugs of abuse 17. Who consume nicotine, caffeine and theine 18. Who have an allergy to apples or significant gastrointestinal disorders 19. Taking medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lipid and carbohydrate metabolism will be assessed through the reduction of blood lipid and glucose levels, respectively, using the following methods at baseline (t0), 90 days (t1), 180 days (t2), and 270 days (t3) of treatment: Determination of blood levels measured using standard blood tests of: 1. Total cholesterol (TC) 2. LDL cholesterol (LDL-C) 3. HDL cholesterol (HDL-C) 4. Triglycerides (TG) 5. Glycated hemoglobin (HbA1c) 6. Glycemia | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Body weight measured through reduction in BMI (Body Mass Index) and abdominal circumference at baseline (t0), 180 days (t2) and 270 days (t3) of treatment 2. Blood pressure values (diastolic and systolic pressure) measured using a sphygmomanometer at baseline (t0), 90 days (t1), 180 days (t2), and 270 days (t3) of treatment 3. Levels of inflammation and pro-inflammatory cytokines measured through the determination of the blood concentration of the following biomarkers at baseline (t0), 270 days (t3) of treatment: 3.1. White blood cells (WBC)- erythrocyte sedimentation rate (ESR)- C-reactive protein (CRP) 3.2. TNF-a- IL-6 3.3. - IL-1-ß 4. Specific liver markers measured through the determination of the following blood concentration of biomarkers at baseline (t0), 90 days (t1), 180 days (t2), and 270 days (t3) of treatment: 4.1. ALT (alanine aminotransferase) 4.2. AST (aspartate aminotransferase) 4.3. Bilirubina 4.4. Albumin 4.4. Total protein 5. Markers of nonalcoholic fatty liver disease (NAFLD) will be measured by LC-MS/MS-based proteomics and metabolomics analysis of serum samples at baseline (t0), 90 days (t1), 180 days (t2), and 270 days (t3) | — |
Countries
Italy
Contacts
Public ContactAlessandra;Lorenza Francesca Baldi;De Lellis
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Outcome results
None listed