An interventional study of Continuous Aerobic Training twice and Healthy Diet in Fatty Liver, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to female participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-04-27.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
Were included 40 patients with NAFLD followed at the Ambulatory of Non-alcoholic Fatty Liver Disease , Discipline of Clinical Gastroenterology, Clinic Hospital of the Medical School of the University of Sao Paulo (HC-FMUSP). Were included adults women of any race, aged 35 to 75 years, diagnosed with NAFLD and were followed for a period of six months. All patients underwent anthropometric and body composition, as well as analysis of clinical, laboratory before and after 6 months of exercise training protocol established.
The hypothesis of our research is that aerobic activity had a favorable impact on NAFLD. It is expected that the intervention of physical activity causes a decrease or no weight, decreased levels of aminotransferases, decreased insulin resistance assessed by homeostasis model assessment (HOMA) index and consequently decrease or reversal of hepatic steatosis.
The Nonalcoholic fatty liver disease (NAFLD) is the most common form of liver diseases, affecting approximately 20-30% of the adult population and is more common in obese individuals (70-80%). The main risk factors associated with the disease are the components of the Metabolic syndrome. To date, there is no specific pharmacological treatment for NAFLD and changes in lifestyle with weight reduction and exercise are always recommended. Few data exist on the impact of physical activity and optimal nutritional strategy for the treatment of NAFLD. Seen the need to elucidate the impact of physical activity and the search for an ideal nutritional strategy in the treatment of NAFLD, the investigators proposed a randomized controlled trial evaluating the effects of a hypocaloric high-protein diet and aerobic exercise associated with this diet on metabolic and anthropometric parameters in sedentary postmenopausal women. 40 sedentary postmenopausal women with NAFLD who had liver biopsy for a period equal to or less than 2 (two) years were included. These patients were randomized into 2 groups: TRAINING group (19): aerobic training with hypocaloric high-protein diet and DIET group (21): only hypocaloric high-protein diet, and followed for a period of six months.
Laboratorial Assays (baseline and end of the protocol)
Anthropometrical Evaluation (baseline and end of the protocol)
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This study's enrollment of 40 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
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Exclusion Criteria:
Aerobic training continuous (n=19 patients) carry a protocol continuous aerobic training twice a week for 24 weeks and the session will last 60 minutes/2 days/week with recommendation for healthy diet.
Behavioral: Continuous Aerobic Training twice · Behavioral: Healthy Diet
Diet group (n=21 patients) only recommendation for healthy diet.
Behavioral: Healthy Diet
Supervised aerobic exercise program of 60 min/2 days/week at 60-85% of heart rate reserve for 24 weeks and healthy diet
Diet group (21) Recommendation for healthy diet.
Efficacy in reduce inflammatory component of NASH for transient elastography liver
Determine the efficacy of the physical activity in reducing the systemic inflammatory component of NASH in patients with NAFLD for transient elastography liver, FibroScan (FS) \[stiffness liver (SL) /CAP\]
Time frame: 6 months
Inflammatory systemic profile
Measure tumoral factor TNFalfa, interleukin 6 (IL6), adiponectin, lipidic and laboratory tests aspartate aminotransferase (AST), alanine aminotransferase (ALT), Cholesterol, total triglycerides, glicemy, insulin.
Time frame: 6 months
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital