Orange Juice Consumption in Patients With Hepatitis C

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Infection
• Intervention / Treatment: Other: Orange juice (500 mL/d)

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Araraquara, Sao Paulo, Brazil, 14800-903
      • Sao Paulo State University "Julio de Mesquita Filho"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Orange juice; 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); 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.
NO_INTERVENTION: Control; 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?

Primary Outcome Measures

Outcome Measure	Time Frame
Total cholesterol	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Triglycerides	8 weeks
Waist circumference	8 weeks
HOMA-IR	8 weeks
Body mass index	8 weeks
Insulin	8 weeks
Glucose	8 weeks
Body mass	8 weeks
% body fat	8 weeks
LDL-C	8 weeks
HDL-C	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

Collaborators and Investigators

• Sponsor: São Paulo State University
• Investigators: Principal Investigator: Thais B Cesar, Ph.D, Sao Paulo State University "Julio de Mesquita Filho"

Publications and helpful links

General Publications

• Dourado GK, Cesar TB. Investigation of cytokines, oxidative stress, metabolic, and inflammatory biomarkers after orange juice consumption by normal and overweight subjects. Food Nutr Res. 2015 Oct 20;59:28147. doi: 10.3402/fnr.v59.28147. eCollection 2015.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (ESTIMATE): January 20, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): January 23, 2017
• Last Update Submitted That Met QC Criteria: January 20, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: nutritional status; oxidative stress; antioxidants; orange juice; chronic hepatitis C; biochemical markers
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: SaoPSU11