Status:
UNKNOWN
Prevention and Reversion of NAFLD in Obese Patients With Metabolic Syndrome by Mediterranean Diet and Physical Activity
Lead Sponsor:
University of the Balearic Islands
Collaborating Sponsors:
Fundació La Marató de TV3
Conditions:
Non Alcoholic Fatty Liver Disease
Eligibility:
All Genders
40-60 years
Phase:
NA
Brief Summary
This prospective randomized trial evaluates the role of customized dietary and physical activity intervention on the progression of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients with obesity a...
Detailed Description
There is currently no licensed pharmacological treatment for reversing Non-Alcoholic Fatty Liver Disease (NAFLD), this is why nutritional and lifestyle strategies are pivotal to ameliorate risk factor...
Eligibility Criteria
Inclusion
- Age between 40 and 60 years
- Diagnosis of NAFLD by ultrasound
- BMI ≥ 27 and \< 40 kg/m2
- Meeting at least 3 of 5 criteria for the metabolic syndrome \[as described in the International Diabetes Federation consensus\]: (1) BMI \>30kg/m² or increased waist circumference: ≥ 94 cm in males; ≥ 80 cm in females; (2) Triglycerides (TG) levels ≥ 150 mg/dL (1.7 mmol/L) or specific treatment; (3) Reduced HDL cholesterol: \< 40 mg/dL (1.03 mmol/L) in males; \< 50 mg/dL (1.29 mmol/L) in females or specific treatment; (4) Raised blood pressure: systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg or treatment of previously diagnosed hypertension; (5) Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes
- Written informed consent
Exclusion
- Inability or unwillingness to give informed consent or communicate with staff study
- Documented history of prior cardiovascular disease \[angina; myocardial infarction; coronary revascularization procedures; stroke (ischemic or hemorrhagic including transient ischemic attacks); symptomatic peripheral artery disease that required surgery or was diagnosed with vascular imaging techniques; ventricular arrhythmia; uncontrolled atrial fibrillation; congestive heart failure (New York Heart Association Class III or IV); hypertrophic myocardiopathy; and history of aortic aneurism \>=5.5cm in diameter or aortic aneurism surgery\]
- Documented history of prior liver diseases (other than NAFLD)
- Active cancer or a history of malignancy in the last 5 years
- Low predicted probability to change food habits according to the Stages of Change Model (Nigg, 1999)
- Unwillingness or inability to adhere to the dietary and physical activity intervention over the entire period of the study
- Failure to follow scheduled visits
- Weight loss (\>5 kg) during 6 months prior to visit
- Previous surgical procedures for weight loss or scheduled bariatric surgery within the next 12 months
- Use of weight loss medications during 6 months prior to visit
- Previous history of bowel resection, inflammatory bowel disease
- Obesity associated with endocrine disease (except treated hypothyroidism)
- Allergy to Mediterranean diet foods or components
- Severe psychiatric disorders (schizophrenia, bipolar disorder, eating disorders, or depression with hospitalization within the last 6 months) or Beck Depression Inventory score \> 30
- Severe condition with less than 24 months life expectancy
- Chronic abuse of drugs or alcohol (\>21 and \>14 units of alcohol a week for men and women, respectively; 1 unit = 125 mL of wine)
- Treatment with steroids
- Pregnancy
Key Trial Info
Start Date :
October 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04442620
Start Date
October 26 2017
End Date
December 1 2021
Last Update
June 22 2020
Active Locations (1)
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1
University of the Balearic Islands
Palma, Balearic Islands, Spain, 07122