Orange Juice Consumption in Patients With Hepatitis C

Study Overview
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Brief Summary
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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
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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.

Official Title
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Orange Juice as Dietary Source of Antioxidants for Patients With Hepatitis C Under Antiviral Therapy

Conditions
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Chronic Infection

Intervention / Treatment
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* Other: Orange juice (500 mL/d)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orange juice<br>Orange juice: twenty-three patients with chronic hepatitis C under pegylated interferon combined with ribavirin treatment were supplemented with 100% commercial pasteurized orange juice (500 mL/d) during 8 weeks. | Other: Orange juice (500 mL/d)<br>* 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.<br>|
| No Intervention: Control<br>Control: twenty patients with chronic hepatitis C under pegylated interferon combined with ribavirin treatment were monitored for consumption of orange juice during 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass |  | 8 weeks | 
| 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 | 
| Triglycerides |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orange juice, chronic hepatitis C, biochemical markers, oxidative stress, nutritional status, antioxidants