Chronic Infection
Conditions
Keywords
orange juice, chronic hepatitis C, biochemical markers, oxidative stress, nutritional status, antioxidants
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
São Paulo State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total cholesterol | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Body mass index | 8 weeks |
| % body fat | 8 weeks |
| Waist circumference | 8 weeks |
| Glucose | 8 weeks |
| Insulin | 8 weeks |
| HOMA-IR | 8 weeks |
| LDL-C | 8 weeks |
| HDL-C | 8 weeks |
| Body mass | 8 weeks |
| CRP | 8 weeks |
| alkaline phosphatase | 8 weeks |
| AST | 8 weeks |
| ALT | 8 weeks |
| gamma-GT | 8 weeks |
| TBARS | 8 weeks |
| ABTS | 8 weeks |
| Triglycerides | 8 weeks |
Countries
Brazil
Outcome results
None listed