Orange Juice Consumption in Patients With Hepatitis C

NCT ID: NCT03026569

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-09-30

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.

Conditions

Chronic Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Orange juice (500 mL/d)

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

São Paulo State University

OTHER

Sponsor Role: lead

Responsible Party

Thais Cesar

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thais B Cesar, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Sao Paulo State University "Julio de Mesquita Filho"

Locations

Sao Paulo State University "Julio de Mesquita Filho"

Araraquara, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 26490535 (View on PubMed)

Other Identifiers

SaoPSU11

Identifier Type: -

Identifier Source: org_study_id