An interventional study of Orange juice (500 mL/d) in Chronic Infection, sponsored by São Paulo State University. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-01-23.
Sponsored by São Paulo State University · Not applicable, Interventional, and Treatment
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.
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.
44 studies on the registry are indexed under Persistent Infection; 5 are open to participants now.
This study's enrollment of 43 is below the median of 104 across 28 interventional studies indexed under Persistent Infection.
Browse Persistent Infection studies →São Paulo State University is the lead sponsor of 34 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Control: twenty patients with chronic hepatitis C under pegylated interferon combined with ribavirin treatment were monitored for consumption of orange juice during 12 weeks.
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.
Total cholesterol
Time frame: 8 weeks
Body mass
Time frame: 8 weeks
Body mass index
Time frame: 8 weeks
% body fat
Time frame: 8 weeks
Waist circumference
Time frame: 8 weeks
Glucose
Time frame: 8 weeks
Insulin
Time frame: 8 weeks
HOMA-IR
Time frame: 8 weeks
LDL-C
Time frame: 8 weeks
HDL-C
Time frame: 8 weeks
Triglycerides
Time frame: 8 weeks
CRP
Time frame: 8 weeks
alkaline phosphatase
Time frame: 8 weeks
AST
Time frame: 8 weeks
ALT
Time frame: 8 weeks
gamma-GT
Time frame: 8 weeks
TBARS
Time frame: 8 weeks
ABTS
Time frame: 8 weeks
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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São Paulo State University