Effect of fish oil supplementation on the concentration of miRNA-122, FGF-21 and liver fibrosis in patients with NAFLD: Study protocol for a randomized, double-blind and placebo-controlled clinical trial.

BACKGROUND & AIMS: To date, no specific drugs are available for non-alcoholic fatty liver disease (NAFLD), though the effect of fish oil supplementation on improving fibrosis in patients with NAFLD has been evaluated. N-3 polyunsaturated fatty acids (n-3 PUFA) may modulate the concentration of microRNAs (miRNAs) and fibroblast growth factor (FGF)-21, which have been identified as non-invasive markers of liver fibrosis. The present study aims to evaluate whether n-3 PUFA supplementation can modulate miRNA-122 and FGF-21 and improve liver fibrosis and steatosis, measured by transient hepatic elastography (THE), in individuals with NAFLD. METHODS: A randomized, double-blind, placebo-controlled clinical trial will be conducted to evaluate the effect of 4 g/day supplementation of fish oil (2100 mg EPA and 924 mg DHA) in patients with NAFLD over a 6-month period. Fifty-two patients aged >19 years will be randomly assigned to either a placebo (olive oil) or treatment (fish oil) group. Anthropometric data, food intake, physical activity, body composition, resting energy expenditure (evaluated using indirect calorimetry), liver enzymes, platelets, lipids and glucose profile, inflammatory markers (such as C-reactive protein, neutrophil/lymphocyte, platelet/lymphocyte, and monocyte/lymphocyte ratios), miRNA-122 and FGF-21 concentration, and incorporation of fatty acids into the erythrocyte membrane (analyzed using gas chromatography) as well as the degree of liver fibrosis and steatosis assessed using THE (Fibroscan® Touch 502, Paris, France) and liver biomarkers Steato-Brazilian Longitudinal Study of Adult Health, Fatty Liver Index, NAFLD Fibrosis Score, Fibrosis-4 score, and FibroScan-AST score will be evaluated at the beginning and end of the treatment. Continuous variables with normal distribution will be compared between placebo and intervention groups using Student's T test for independent samples; continuous non-parametric variables will be compared using Dunn or Mann-Whitney test. Associations between categorical variables will be analyzed using the chi-square test, and within-group differences will be evaluated using the Wilcoxon signed-ranks test. The criterion for determining significance will be set at 5%. CONCLUSION: The present study protocol will investigate the supplementation of EPA-rich fish oil as an alternative treatment for NAFLD and its feasibility in affecting the concentration of miRNA-122 and FGF-21 markers. Its findings will offer valuable contributions to the literature. REGISTRATION: ReBEC number RBR-8dp876.

The patient generated-subjective global assessment (PG-SGA) and ECOG performance status are associated with mortality in patients hospitalized with breast cancer.

AIM: This study evaluated the association between risk of malnutrition and performance status, and mortality in hospitalized breast cancer patients. METHODS: Prospective cohort study with hospitalized breast cancer patients evaluated at a referral Cancer Center. The Risk of malnutrition was assessed by the Patient-Generated Subjective Global Assessment (PG-SGA) and performance status was determined using the Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS). Logistic regression was used to analyze the factors associated with death, using the odds ratio (OR) with a 95% confidence interval (CI) as an effect measure. RESULTS: A total of 195 woman were included, with a mean age of 56.3 (±12.6) years. Patients with an overall PG-SGA score ≥18 (OR: 2.11; 95% CI: 1.03-4.62) and ECOG PS ≥ 3 (OR: 3.34; 95% CI: 1.48-7.52) had a higher occurrence of death during hospitalization, regardless of age or disease stage. The concomitant presence of these two factors improved the accuracy of the association (OR: 5.32; 95% CI: 3.11-9.76) and showed good predictive accuracy (C-statistics: 0.77). CONCLUSION: Nutritional risk and poor performance status were associated with a higher occurrence of death in women with breast cancer. The use of these two indicators improves their predictive accuracy for mortality.

Impact of energy deficit during hospitalization and biomarkers at admission on clinical outcomes in critically ill children: A longitudinal study.

BACKGROUND & AIMS: To evaluate the impact of energy deficit during hospitalization and the biomarkers albumin and C-reactive protein (CRP) on the clinical outcomes length of stay (LOS) and duration of mechanical ventilation (DMV) in children and adolescents admitted to the pediatric intensive care unit (PICU) of a private hospital in Rio de Janeiro. METHODS: A longitudinal, retrospective study was conducted of the medical records of patients admitted to the PICU from May 2016 to June 2017 who received enteral nutrition (EN) for 72 h or longer. The cut-off points for serum albumin and CRP were set at ≥3.5 and <2.0, respectively. The energy balance was calculated as the difference between the energy prescribed and the energy received by the patient. The comparison of continuous variables related to LOS and DMV was assessed using Student's t-test and the Mann-Whitney test. The significance value was set at p < 0.05. RESULTS: Ninety-three patients were selected, with a median age of 32 (±39.49) months. The mean serum albumin and CRP levels were 4.04 (±0.59) and 4.67 (±7.40), respectively. In linear regression models adjusted for length of stay, reduced albumin, increased CRP, and negative energy balance were positively associated. In the models adjusted to DMV, the values for reduced albumin and increased CRP were significant. CONCLUSION: A significant association was found between serum albumin and CRP at admission and the outcomes under investigation, LOS and DMV. Energy deficit was also associated with LOS.

Patient-generated subjective global assessment predicts cachexia and death in patients with head, neck and abdominal cancer: A retrospective longitudinal study.

BACKGROUND & AIMS: Cancer is a complex disease, with poor prognosis when associated with malnutrition. This condition can lead to Cancer Cachexia (CC), a syndrome characterized by loss of muscle mass with or without fat loss, often associated with higher risk of death. Although there are recommended screening tools to assess nutritional status in cancer patients, such as Patient-Generated Subjective Global Assessment (PG-SGA), little is known about CC prediction. The aim was to investigate the association between nutritional status of patients with head, neck and abdominal cancer, assessed by PG-SGA at the day of hospitalization, with CC, hospitalization time and death. METHODS: This is a retrospective longitudinal study, where we collected data of 97 patients about PG-SGA nutritional classification, anthropometry, gender, age, cachexia diagnosis and death. RESULTS: PG-SGA classification was strongly associated with all the anthropometric measures (p < 0.0001). According to PG-SGA classification, 30.61% (n = 15) of patients in group A developed pre-cachexia; 38.24% in group B developed CC (n = 13); and 60% (n = 9) in group C developed refractory cachexia (p < 0.0001). Death rate was 24.49% (n = 12), 54.55% (n = 18) and 80% (n = 12) in groups A, B and C, respectively (p < 0.0001). PG-SGA had good sensibility (89.5%) and accuracy (72%) for CC, and also good specificity (75.51%) and accuracy (69%) for death. CONCLUSIONS: PG-SGA demonstrated a significative association with the variables measured and was able to predict CC and death. This, in addition to its simple applicability, suggests that PG-SGA can be a useful tool to screen cancer patients for CC establishment and death risk.