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Lifestyle Intervention in Fatty Liver (NAFLD) (FOIEGRAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03354247
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : January 24, 2019
European Commission
Information provided by (Responsible Party):
piero portincasa, University of Bari

Brief Summary:

Non-Alcoholic Fatty Liver Disease (NAFLD), including its more pathologic consequence, non-alcoholic steatohepatitis (NASH), is believed to be the most common chronic liver disease worldwide, affecting between 6 to 37% of the population. NAFLD is a so called 'silent killer', as clinical symptoms only surface at late stages of the disease, when it is no longer treatable: untreated, NAFLD/NASH can lead to cirrhosis and hepatocellular carcinoma, culminating in liver failure. Several factors may contribute to the pathogenesis of NAFLD, including genetic assessment and mitochondrial dysfunction. Patients with NAFLD/NASH display disturbances of intestinal permeability, and gut microbiota. In the most of cases, NAFLD/NASH is strongly linked to other metabolic conditions, including visceral adiposity. Currently the best method of diagnosing and staging the disease is liver biopsy, a costly, invasive and somewhat risky procedure, not to mention unfit for routine assessment. Weight loss is the first step approach with reasonable evidence suggesting it is beneficial and safe in NAFLD/NASH patients. However, the efficacy of weight reduction for the treatment of NAFLD/NASH has not been carefully evaluated. Several studies on the effects of weight reduction on NAFLD/NASH have been uncontrolled, used poorly defined patient populations and non-standardized weight loss interventions, and lacked a well-accepted primary outcome for NASH.

The objective of the project is to conduct a randomized controlled trial of 1 year-long weight reduction in the management of NAFLD/NASH patients using a lifestyle-dietary intervention program. Overweight or obese individuals with biopsy or ultrasonography (US) -proven NAFLD/NASH will be randomized to receive either standard medical care and educational sessions related to NAFLD/NASH, healthy eating, weight loss, and exercise (control group); or to an intensive weight management with a goal of at least 7-10 % weight reduction (lifestyle intervention group). The weight loss intervention will be modelled on Mediterranean-intervention-diet. The investigators hypothesize that a 7-10% weight reduction through intensive lifestyle intervention will lead to improvement of clinical, US, anthropometric, and biochemical features on patients diagnosed with NAFLD/NASH.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Behavioral: Lifestyle Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioenergetic Remodeling in the Pathophysiology and Treatment of Non-Alcoholic Liver Disease
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
No Intervention: Healthy Control
Participants in this group will attend small group sessions providing basic education about NAFLD/NASH, and about principles of healthy eating, physical activity and weight control. These sessions occur every 12 weeks and are conducted by a Master's level nutritionist or health educator. Providing basic education about diet and exercise has produced minimal weight loss in other clinical trials. The educational sessions will be included in this study in order to provide standard care to these patients and to maximize subject retention.
Experimental: NAFLD Intervention
Participants randomized to the Lifestyle Intervention will receive an intensive, state-of-the-art weight loss intervention based on a Mediterranean diet and physical activity. The intervention will focus on changing both eating and exercise habits with a goal of producing a 7-10% weight loss within the first 6 months and then maintaining this weight loss. Participants who are able to lose more than 10% of their body weight will be encouraged to do so. Participants will be seen weekly for the first 6 months and then biweekly for months 7-12. The lifestyle intervention focused on diet, exercise, and behavior modification.
Behavioral: Lifestyle Intervention
Participants randomized to the Lifestyle Intervention will receive an intensive, state-of-the-art weight loss intervention based on a Mediterranean diet and physical activity. The intervention will focus on changing both eating and exercise habits with a goal of producing a 7-10% weight loss within the first 6 months and then maintaining this weight loss. Participants will be evaluate using validated questionnaires and adherence scores to assess food intake and physical activity, and will then be closely followed during the intervention period.

Primary Outcome Measures :
  1. Changes in food intake and Mediterranean diet adherence score [ Time Frame: 0, 6, 12 months ]
    Qualitative nutritional analysis of patients' dietary habits will be measured by a validated 110-items food frequency questionnaire. Change in frequency of intake will be evaluated during the intervention to assess adherence to the Mediterranean diet, according to a validated score. The score goes from 0-18 and classifies the intake of the following 9 items: fruits, vegetables, legumes, cereals, fish, meat and meat products, dairy products, alcohol, and olive oil. Each item is scored from 0-2, depending on the adequacy of the range of habitual intake. For fruits, vegetables, legumes, cereals, fish, and olive oil, the higher the intake the higher the score; for dairy, meat and meat products, the higher the intake, the lower the score; for alcohol, a higher score is given for moderate intake, a 1 score for low intake and a 0 for higher intake. A higher score after intervention is desirable as it represents better adherence to the Mediterranean diet.

  2. Changes in physical activity level [ Time Frame: 0, 6, 12 months ]
    Changes in physical activity level will be assessed by a validated physical activity questionnaire. Physical activity level is classified into number of metabolic equivalent of tasks (METs) per minute per week. The range goes from light physical activity level (3 METs/min/week), to moderate (4.5 METs/min/week), to vigorous (6 METs/min/week). Assessment of appropriateness of level of physical activity will be done by comparison with the the recommended by the American College of Sports Medicine / American Heart Association (ACSM/AHA). Changes in level of physical activity will be used to evaluate adherence of the patients to the lifestyle intervention aiming a higher level of physical activity than at baseline (if low) or a maintenance of physical activity level (if already adequate).

  3. Changes in body mass index [ Time Frame: 0, 6, 12 months ]
    The body mass index (BMI), composed by weight and height of the patient (kg/m^2) will be used for classification of patients into the following categories according to the World Health Organization: BMI < 18.5 kg/m^2, underweight; BMI 18.5 - 24.9 kg/m^2, normal weight; BMI of 25.0 - 29.9 kg/m^2, overweight; BMI 30.0 - 34.9 kg/m^2, obesity class I; BMI 35.0 - 39.9 kg/m^2, obesity class II; and BMI > 40.0 kg/m^2, obesity class III. Changes in the absolute value and the classification will be evaluated, aiming at a classification of normal weight level or reduction of absolute level.

  4. Changes in abdominal girth [ Time Frame: 0, 6, 12 months ]
    The abdominal circumference will be measure and used to classify metabolic risk according to the ATP III criteria -- for men, increased risk when abdominal girth is above 102 cm, and for women, increased risk of circumference over 88 cm. Reductions in the abdominal circumference will be evaluated with the goal of reaching values lower than baseline values, ideally under these cut-off points.

  5. Changes in liver steatosis score according to ultrasonography [ Time Frame: 0, 6, 12 months ]
    Evaluation of fat in the liver, as assessed by ultrasonography, can be classified into a score of 0-3, 0 standing for no accumulation of fat in the liver, and 1-3 describing increasing levels of fat accumulation. Changes in this score will be evaluated at selected time points to verify if adherence to the proposed lifestyle changes will reduce the amount of fat accumulation in the liver, and hence, the score.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients able to provide informed consent
  • Certified diagnosis of NAFLD/NASH
  • Body mass index between 25-40 Kg/m2
  • Biohumoral alterations of lipidic and/or glucidic and/or liver metabolism

Exclusion Criteria:

  • Refusal to sign the informed consent
  • Diagnosis of organic diseases including neoplastic, severe cardiovascular diseases, renal insufficiency, psychiatric disorders
  • Significant alcohol consumption (> 1 standard drink per day),
  • Inability to walk 2 blocks or a quarter of a mile without stopping
  • Engagement in an active weight loss program or taking weight loss medication
  • Substance abuse
  • Medication able to affect gastrointestinal tract and to interfere with symptoms
  • Pregnancy
  • Presence of diseases with a prognosis of less than 12 months

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 identifier (NCT number): NCT03354247

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Contact: Piero Portincasa, MD, PhD +39 0805478227

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Department of Biomedical Sciences Human Oncology - Clinica Medica "A. Murri" Recruiting
Bari, BA, Italy, 70124
Contact: Piero Portincasa, MD, PhD    +39 0805478227   
Sponsors and Collaborators
University of Bari
European Commission
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Principal Investigator: Piero Portincasa, MD, PhD University of Bari
Additional Information:

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Responsible Party: piero portincasa, Professor, University of Bari Identifier: NCT03354247    
Other Study ID Numbers: 722619
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases