Prevention and Reversion of NAFLD in Obese Patients With Metabolic Syndrome by Mediterranean Diet and Physical Activity

NCT04442620 | Unknown

• 1 other identifier: 201630.10
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 and presenting at least three of the main Metabolic Syndrome traits. The project proposes a personalized nutritional intervention based on a Mediterranean customized diet which introduces plenty of antioxidant and anti-inflammatory bioactive components, coupled with physical activity promotion to prevent and reverse NAFLD among obese patients with metabolic syndrome. This will be compared with two more dietary strategies including a Mediterranean Diet intervention with seven meals a day and the conventional dietary approach proposed by the American Association for the Study of Liver Diseases (AASLD).

Conditions

Non Alcoholic Fatty Liver Disease

Keywords

Non Alcoholic Fatty Liver Disease; Metabolic syndrome; Mediterranean Diet; Physical activity

Outcome Measures

Primary Outcomes (1)

• Changes in liver steatosis

  The primary outcome is to measure the change of liver steatosis (expressed as percentage of liver steatosis) after applying a different intervention to each group (PA-MD; HMF-MD; or CD) of participants with metabolic syndrome. It will be measured (at baseline, and after 6, 12 and 24 months of intervention) by means of a 1.5-T Magnetic Resonance Imaging (MRI) (Signa Explorer 1.5T, General Electric Healthcare, Chicago, Illinois., U.S.A) by using a 12-channel phased-array coil.

  At baseline, 6, 12 and 24 months

Secondary Outcomes (1)

• Changes in liver fibrosis

  At baseline, 6, 12 and 24 months

Study Arms (3)

1st group: Physical Activity and Mediterranean Diet (PA-MD)

EXPERIMENTAL

A first group of participants will be advised to reduce their caloric intake by 25-30% with a macronutrients distribution of 35-40% fat, 20% proteins, and 40-45% carbohydrates. Healthy fats (a maximum of 8-10% from saturated fats, \>20% from monounsaturated fats, \>10% from polyunsaturated fats and \<300 mg/day of cholesterol) and low glycaemic index foods rich in fibre (not less than 30-35g /day) are strongly advised, together with foods rich in antioxidants, namely fruits and vegetables. Such diet reflects the traditional Mediterranean Diet described in the PREDIMED (Primary Prevention of Cardiovascular Disease with a Mediterranean Diet)-Plus study. As for physical activity, patients the participants will be recommended a 35 minutes interval training session three times a week. Physical activity sessions of 35 minutes will consist of 5 minutes warm-up, 20 minutes interval training, and 10 minutes breathing and stretching.

Other: Physical activity and Mediterranean Diet (PA-MD)

2nd group: High Meal Frequency of Mediterranean Diet (HMF-MD)

EXPERIMENTAL

A second group of participants will be advised to reduce their caloric intake by 25-30% with a macronutrients distribution of 30-35% fat, 25% proteins, and 40-45% carbohydrates. Healthy fats and low glycaemic index foods will be strongly advised, together with foods rich in antioxidants, namely fruits and vegetables. Participants will be advised to consume 7 meals a day, gradually reducing the caloric content at each main meal, and to walk 10.000 steps a day.

Other: High meal frequency of Mediterranean Diet (HMF-MD)

3rd group: Control diet (CD)

ACTIVE COMPARATOR

A third group of participants will be advised to reduce their caloric intake by 25-30% with a macronutrients distribution of 30% fat, 15% proteins, and 55% carbohydrates, and maintain an adequate fibre (25g/day) and cholesterol (\<250mg/day) intake. Meal frequency will be of 3-5 meals a day. Moreover, the participants will be advised to walk 10.000 steps a day.

Other: Control diet (CD)

Interventions

Physical activity and Mediterranean Diet (PA-MD) OTHER

Physical Activity plus caloric restricted Mediterranean diet

1st group: Physical Activity and Mediterranean Diet (PA-MD)

High meal frequency of Mediterranean Diet (HMF-MD) OTHER

High meal frequency of unaltered Mediterranean diet

2nd group: High Meal Frequency of Mediterranean Diet (HMF-MD)

Control diet (CD) OTHER

Control Diet

3rd group: Control diet (CD)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Balearic Islands: lead
• Fundació La Marató de TV3: collaborator

Study Sites (1)

University of the Balearic Islands

Palma, Balearic Islands, 07122, Spain

Location

Related Publications (1)

• Quetglas-Llabres MM, Monserrat-Mesquida M, Bouzas C, Llompart I, Mateos D, Casares M, Ugarriza L, Martinez JA, Tur JA, Sureda A. Mediterranean Diet Improves Plasma Biomarkers Related to Oxidative Stress and Inflammatory Process in Patients with Non-Alcoholic Fatty Liver Disease. Antioxidants (Basel). 2023 Mar 29;12(4):833. doi: 10.3390/antiox12040833.

  PMID: 37107208 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Metabolic Syndrome; Motor Activity

Interventions

Exercise; Diet, Mediterranean

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Josep A Tur, PhD

  University of the Balearic Islands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physiology

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: June 22, 2020
• Study Start: October 26, 2017
• Primary Completion: November 29, 2019
• Study Completion: December 1, 2021
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)