Orange Juice Consumption in Patients With Hepatitis C

Chronic Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026569
• Other study ID #: SaoPSU11
• Status: Completed
• Phase: N/A
• First received: January 17, 2017
• Last updated: January 20, 2017
• Start date: May 2012
• Est. completion date: September 2012

Study information

• Verified date: January 2017
• Source: São Paulo State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Infection
• Hepatitis
• Hepatitis C

Intervention

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.

Locations

Country	Name	City	State
Brazil	Sao Paulo State University "Julio de Mesquita Filho"	Araraquara	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
São Paulo State University

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cholesterol		8 weeks
Secondary	Body mass		8 weeks
Secondary	Body mass index		8 weeks
Secondary	% body fat		8 weeks
Secondary	Waist circumference		8 weeks
Secondary	Glucose		8 weeks
Secondary	Insulin		8 weeks
Secondary	HOMA-IR		8 weeks
Secondary	LDL-C		8 weeks
Secondary	HDL-C		8 weeks
Secondary	Triglycerides		8 weeks
Secondary	CRP		8 weeks
Secondary	alkaline phosphatase		8 weeks
Secondary	AST		8 weeks
Secondary	ALT		8 weeks
Secondary	gamma-GT		8 weeks
Secondary	TBARS		8 weeks
Secondary	ABTS		8 weeks