Orange Juice Consumption in Patients With Hepatitis C
Orange Juice as Dietary Source of Antioxidants for Patients With Hepatitis C Under Antiviral Therapy
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 17, 2017
CompletedFirst Posted
Study publicly available on registry
January 20, 2017
CompletedJanuary 23, 2017
January 1, 2017
2 months
January 17, 2017
January 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total cholesterol
8 weeks
Secondary Outcomes (17)
Body mass
8 weeks
Body mass index
8 weeks
% body fat
8 weeks
Waist circumference
8 weeks
Glucose
8 weeks
- +12 more secondary outcomes
Study Arms (2)
Orange juice
EXPERIMENTALOrange 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
NO INTERVENTIONControl: twenty patients with chronic hepatitis C under pegylated interferon combined with ribavirin treatment were monitored for consumption of orange juice during 12 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Detection of circulating HCV RNA
- Negative HBV surface antigen
- Negative antibodies to HIV
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sao Paulo State University "Julio de Mesquita Filho"
Araraquara, São Paulo, 14800-903, Brazil
Related 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. eCollection 2015.
PMID: 26490535BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thais B Cesar, Ph.D
Sao Paulo State University "Julio de Mesquita Filho"
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
January 17, 2017
First Posted
January 20, 2017
Study Start
May 1, 2012
Primary Completion
July 1, 2012
Study Completion
September 1, 2012
Last Updated
January 23, 2017
Record last verified: 2017-01