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Sedentary Postmenopausal Women With Nonalcoholic Fatty Liver Disease (NAFLD) Submitted to Physical Activity

Anthropometric Evaluation and Body Composition in Sedentary Postmenopausal Women With Nonalcoholic Fatty Liver Disease (NAFLD) Submitted to Physical Activity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02427087
Enrollment
40
Registered
2015-04-27
Start date
2013-01-31
Completion date
2014-12-31
Last updated
2015-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver

Keywords

Nonalcoholic fatty liver, Physical activity, NAFLD, Anthropometry, Body Composition

Brief summary

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.

Detailed description

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) * AST, ALT, FA, GGT, albumine, Fe, fasting glucose, insulin, Total cholesterol, HDL, LDL, Triglycerides; * TNFalfa, IL6, and adiponectin. Anthropometrical Evaluation (baseline and end of the protocol) * BMI, waist circumference, percent body fat, body fat mass, lean body mass

Interventions

BEHAVIORALContinuous Aerobic Training twice

Supervised aerobic exercise program of 60 min/2 days/week at 60-85% of heart rate reserve for 24 weeks and healthy diet

BEHAVIORALHealthy Diet

Diet group (21) Recommendation for healthy diet.

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 35-75 years of age, Female * Biopsy-liver until 24 months previous that prove NAFLD or NASH * Patients who agree to participate in the study and all signed informed consent.

Exclusion criteria

* Presence of alcoholism \<20g (women) of ethanol/day, drugs, schistosomiasis, hepatitis B or C and other chronic liver diseases cause determined * Without medical clearance for physical activity * Without availability to attend appointments and physical activities 2x/week * Significant change in dietary habits and/or exercise in the last 3 months that resulted in weight loss \> 5%.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy in reduce inflammatory component of NASH for transient elastography liver6 monthsDetermine the efficacy of the physical activity in reducing the systemic inflammatory component of NASH in patients with NAFLD for transient elastography liver, FibroScan (FS) \[stiffness liver (SL) /CAP\]

Secondary

MeasureTime frameDescription
Inflammatory systemic profile6 monthsMeasure tumoral factor TNFalfa, interleukin 6 (IL6), adiponectin, lipidic and laboratory tests aspartate aminotransferase (AST), alanine aminotransferase (ALT), Cholesterol, total triglycerides, glicemy, insulin.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026