Lifestyle Intervention in Fatty Liver (NAFLD) (FOIEGRAS)
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|ClinicalTrials.gov Identifier: NCT03354247|
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : January 24, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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).
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03354247
|Contact: Piero Portincasa, MD, PhD||+39 firstname.lastname@example.org|
|Department of Biomedical Sciences Human Oncology - Clinica Medica "A. Murri"||Recruiting|
|Bari, BA, Italy, 70124|
|Contact: Piero Portincasa, MD, PhD +39 0805478227 email@example.com|
|Principal Investigator:||Piero Portincasa, MD, PhD||University of Bari|