Orange Juice Consumption in Patients With Hepatitis C
Primary Purpose
Chronic Infection
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Orange juice (500 mL/d)
Sponsored by

About this trial
This is an interventional treatment trial for Chronic Infection focused on measuring orange juice, chronic hepatitis C, biochemical markers, oxidative stress, nutritional status, antioxidants
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
Sites / Locations
- Sao Paulo State University "Julio de Mesquita Filho"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Orange juice
Control
Arm Description
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.
Control: twenty patients with chronic hepatitis C under pegylated interferon combined with ribavirin treatment were monitored for consumption of orange juice during 12 weeks.
Outcomes
Primary Outcome Measures
Total cholesterol
Secondary Outcome Measures
Body mass
Body mass index
% body fat
Waist circumference
Glucose
Insulin
HOMA-IR
LDL-C
HDL-C
Triglycerides
CRP
alkaline phosphatase
AST
ALT
gamma-GT
TBARS
ABTS
Full Information
NCT ID
NCT03026569
First Posted
January 17, 2017
Last Updated
January 20, 2017
Sponsor
São Paulo State University
1. Study Identification
Unique Protocol Identification Number
NCT03026569
Brief Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
São Paulo State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Infection
Keywords
orange juice, chronic hepatitis C, biochemical markers, oxidative stress, nutritional status, antioxidants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orange juice
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control: twenty patients with chronic hepatitis C under pegylated interferon combined with ribavirin treatment were monitored for consumption of orange juice during 12 weeks.
Intervention Type
Other
Intervention Name(s)
Orange juice (500 mL/d)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total cholesterol
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Body mass
Time Frame
8 weeks
Title
Body mass index
Time Frame
8 weeks
Title
% body fat
Time Frame
8 weeks
Title
Waist circumference
Time Frame
8 weeks
Title
Glucose
Time Frame
8 weeks
Title
Insulin
Time Frame
8 weeks
Title
HOMA-IR
Time Frame
8 weeks
Title
LDL-C
Time Frame
8 weeks
Title
HDL-C
Time Frame
8 weeks
Title
Triglycerides
Time Frame
8 weeks
Title
CRP
Time Frame
8 weeks
Title
alkaline phosphatase
Time Frame
8 weeks
Title
AST
Time Frame
8 weeks
Title
ALT
Time Frame
8 weeks
Title
gamma-GT
Time Frame
8 weeks
Title
TBARS
Time Frame
8 weeks
Title
ABTS
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thais B Cesar, Ph.D
Organizational Affiliation
Sao Paulo State University "Julio de Mesquita Filho"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sao Paulo State University "Julio de Mesquita Filho"
City
Araraquara
State/Province
Sao Paulo
ZIP/Postal Code
14800-903
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
26490535
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.
Results Reference
background
Learn more about this trial
Orange Juice Consumption in Patients With Hepatitis C
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