The main goal of this project is to evaluate the effect of immunosuppression in the weight loss and in the metabolic status of patients after liver transplantation. It is also the purpose of this project to investigate why patients become overweight and obese after liver transplantation.
Overweight and obese post-liver transplantation patients will receive a diet to promote weight loss during 6 months. The control group (overweight and obese subjects) will be submitted to the same protocol: The participants will be interviewed at baseline and after 30, 60, 90 and 180 days from baseline. The following measures will be assessed: body composition (fat body% and free fat body%), anthropometric measures (height, weight, body mass index, waist circumference and abdominal circumference), blood pressure, basal metabolic rate, behavioral symptoms and peripheral biomarkers in the serum. Behavioral symptoms will be assessed using the following self-reported questionnaires: Beck Depression Inventory (depression symptoms), Beck Anxiety Inventory (anxiety symptoms), Medical Outcomes Study 36 - Item Short - Form Health Survey (quality of life) and Perceived Stress Scale (stress). Enrolled participants will receive a restrictive diet calculated based on individual requirements aiming the loss of around 5%-10% of weight/ 6 months of intervention.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
Weight loss diet composed of 30% lipids, 30% proteins and 40% carbohydrates.
Hospital da Clínicas da UFMG
Belo Horizonte, Minas Gerais, Brazil
Change in weight measurement from baseline until 6 months follow up.
The weight loss will be measured by weighing volunteers
Time frame: Baseline and 30, 60, 90 and 180 days
Change in body composition from baseline until 6 months follow up.
The effect of the weight loss diet in body composition will be measured by bioimpedance.
Time frame: Baseline and 30, 60, 90 and 180 days
Change in basal metabolic rate from baseline until 6 months follow up.
Basal metabolic rate will be measured by calorimetry.
Time frame: Baseline and 30, 60, 90 and 180 days
Change in inflammatory mediators serum levels from baseline until 6 months follow up.
Nutritional effect in the levels of interleukins, such as Interleukin-1, interleukin-6 and interleukin-10, interleukin-17, tumor necrosis factor and protein C reactive.
Time frame: Baseline and 30, 60, 90 and 180 days
Change in depressive symptoms from baseline until 6 months follow up.
Nutritional effect in depressive symptoms will be measured by the Beck Depression Inventory.
Time frame: Baseline and 30, 60, 90 and 180 days
Change in anxiety symptoms from baseline until 6 months follow up.
Nutritional effect in anxiety symptoms will be measured by the Beck Anxiety Inventory.
Time frame: Baseline and 30, 60, 90 and 180 days
Change in quality of life from baseline until 6 months follow up.
Nutritional effect in quality of life will be measured by Medical Outcomes Study 36 - Item Short - Form Health Survey.
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Time frame: Baseline and 30, 60, 90 and 180 days
Change in perceived stress from baseline until 6 months follow up.
Nutritional effect in perceived stress will be measured by the Perceived Stress Scale.
Time frame: Baseline and 30, 60, 90 and 180 days
Change in quality of diet from baseline until 6 months follow up.
Nutritional effect in quality of diet will be measured by the Healthy Eating Index-10.
Time frame: Baseline and 30, 60, 90 and 180 days
Changes in serum levels of neurotrophic factors from baseline until 6 months follow up.
Nutritional effect in the serum levels of brain-derived neurotrophic factor, glial-derived neurotrophic factor and neurotrophin-3 and neurotrophin 4/5.
Time frame: Baseline and 30, 60, 90 and 180 days
Change in metabolic markers serum levels from baseline until 6 months follow up.
Nutritional effect in the levels of triglycerides, cholesterol and glucose
Time frame: Baseline and 30, 60, 90 and 180 days
Characterization of the immunological response of liver transplanted patients from baseline until 6 months follow up.
Analysis of cytokines in the sera of immunosupressed patients.
Time frame: Baseline and 30, 60, 90 and 180 days
Characterization of the immunological response of liver transplanted patients from baseline until 6 months follow up..
Analysis of cytokines in cell culture (PBMC) of immunosupressed patients.
Time frame: Baseline and 30, 60, 90 and 180 days
Characterization of the immunological profile of liver transplanted patients in the baseline.
The cells will be immuno-phenotyped for the ex vivo condition and also submitted to culture in the presence of different stimuli.
Time frame: Baseline.