Orange Juice Consumption in Patients With Hepatitis C

Not Applicable

Completed

• Conditions: Chronic Infection

• Registration Number: NCT03026569
• Lead Sponsor: São Paulo State University

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.

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2012-07
• Study Completion: 2012-09
• Status Verified: 2017-01
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-20
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total cholesterol	8 weeks

Secondary Outcome Measures

Name	Time	Method
Insulin	8 weeks
ALT	8 weeks
TBARS	8 weeks
Body mass	8 weeks
Body mass index	8 weeks
% body fat	8 weeks
Waist circumference	8 weeks
Glucose	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
gamma-GT	8 weeks
ABTS	8 weeks

Trial Locations

Locations (1)

Sao Paulo State University "Julio de Mesquita Filho"; 🇧🇷 Araraquara, Sao Paulo, Brazil