Clinical trial NCT03026569: Orange Juice Consumption in Patients With Hepatitis C
Official title: Orange Juice as Dietary Source of Antioxidants for Patients With Hepatitis C Under Antiviral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Infection
Keywords: orange juice
chronic hepatitis C
biochemical markers
oxidative stress
nutritional status
antioxidants
Lead sponsor: São Paulo State University
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total cholesterol
timeFrame: 8 weeks
Secondary outcomes:
measure: Body mass
timeFrame: 8 weeks
measure: Body mass index
timeFrame: 8 weeks
measure: % body fat
timeFrame: 8 weeks
measure: Waist circumference
timeFrame: 8 weeks
measure: Glucose
timeFrame: 8 weeks
measure: Insulin
timeFrame: 8 weeks
measure: HOMA-IR
timeFrame: 8 weeks
measure: LDL-C
timeFrame: 8 weeks
measure: HDL-C
timeFrame: 8 weeks
measure: Triglycerides
timeFrame: 8 weeks
measure: CRP
timeFrame: 8 weeks
measure: alkaline phosphatase
timeFrame: 8 weeks
measure: AST
timeFrame: 8 weeks
measure: ALT
timeFrame: 8 weeks
measure: gamma-GT
timeFrame: 8 weeks
measure: TBARS
timeFrame: 8 weeks
measure: ABTS
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Araraquara
country: Brazil
facility: Sao Paulo State University "Julio de Mesquita Filho"
state: Sao Paulo
Study officials:
affiliation: Sao Paulo State University "Julio de Mesquita Filho"
name: Thais B Cesar, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.