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Orange Juice as Dietary Source of Antioxidants for Patients With Hepatitis C Under Antiviral Therapy (NCT03026569)

This study aimed to verify whether orange juice, source of citrus flavonoids and vitamin C, may contribute to the treatment of patients with chronic hepatitis C.
  • Other: Orange juice (500 mL/d)
    The patients were instructed to drink orange juice in two daily portions during eight consecutive weeks. Patients from both groups were asked to maintain their usual lifestyle, diet, and physical activity, and they were checked weekly by the researcher's team. Assessments of anthropometric data, dietary intake, as well as blood sample collection for biochemical analysis were performed in all participants on the first and last day of the experiment.
    Ages eligible for Study
    18 Years to 60 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Detection of circulating HCV RNA
    • Negative HBV surface antigen
    • Negative antibodies to HIV
    Exclusion Criteria:
    • Co-infection with hepatitis B virus (HBV)
    • Co-infection with hepatitis A virus (HAV)
    • Co-infection with human immunodeficiency virus (HIV)
    • Presence of diabetes mellitus,
    • Presence of ascites
    • Elevation in serum ferritin levels
    Forty-three patients with chronic hepatitis C who were being treated with pegylated interferon combined with ribavirin, according to the Clinical Protocol and Therapeutic Guidelines for Viral Hepatitis C and Co-infections of the Brazilian Health Ministry were randomly divided into two parallel groups: (1) orange juice (n = 23), which were supplemented with orange juice (500 mL/d) for 8 weeks; (2) control group (n = 20) composed of patients that were not drinking orange juice regularly. The recruitment process began in February 2012, the intervention was carried out from May 2012 to July 2012, and the data analysis started in September 2012. The sample number took into account variances on total cholesterol with a type I error α = 0.05 and a type II error β = 0.2 (80% power) (Dourado et al., 2015). The minimum sample size should have 20 individuals per group (n = 40), considering an approximately 15% dropout rate. Primary and secondary endpoints were the reduction of total cholesterol and modification of biochemical markers, respectively. Kolmogorov Smirnov and Levene test assessed normality and homogeneity of data, respectively. Assessment of the data was performed in all participants on the first and last day of the experiment. All the parameters were compared between the juice group and the control group using General Linear Model of Repeated Measures Analysis. Differences in baseline patients' characteristics between the two groups were analyzed by One-way analysis of variance (ANOVA). The LSD signed rank post-test was used to assess significant changes in parameters after the start of treatment in each group, and the differences were considered statistically significant at p < 0.05.

    1 locations

    Brazil (1)
    • Sao Paulo State University "Julio de Mesquita Filho"
      Araraquara, Sao Paulo, Brazil, 14800-903
    Status:
    completed
    Type:
    Interventional
    Phase:
    -
    Start:
    30 April, 2012
    Updated:
    19 January, 2017
    Participants:
    43
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