Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-04 @ 8:44 AM
Study NCT ID:
NCT03026569
Status:
COMPLETED
Last Update Posted:
2017-01-23
First Post:
2017-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orange Juice Consumption in Patients With Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000088562', 'term': 'Persistent Infection'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-20', 'studyFirstSubmitDate': '2017-01-17', 'studyFirstSubmitQcDate': '2017-01-17', 'lastUpdatePostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total cholesterol', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['orange juice', 'chronic hepatitis C', 'biochemical markers', 'oxidative stress', 'nutritional status', 'antioxidants'], 'conditions': ['Chronic Infection']}, 'referencesModule': {'references': [{'pmid': '26490535', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Detection of circulating HCV RNA\n* Negative HBV surface antigen\n* Negative antibodies to HIV\n\nExclusion Criteria:\n\n* Co-infection with hepatitis B virus (HBV)\n* Co-infection with hepatitis A virus (HAV)\n* Co-infection with human immunodeficiency virus (HIV)\n* Presence of diabetes mellitus,\n* Presence of ascites\n* Elevation in serum ferritin levels'}, 'identificationModule': {'nctId': 'NCT03026569', 'briefTitle': 'Orange Juice Consumption in Patients With Hepatitis C', 'organization': {'class': 'OTHER', 'fullName': 'São Paulo State University'}, 'officialTitle': 'Orange Juice as Dietary Source of Antioxidants for Patients With Hepatitis C Under Antiviral Therapy', 'orgStudyIdInfo': {'id': 'SaoPSU11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orange juice', '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.', 'interventionNames': ['Other: Orange juice (500 mL/d)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', '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.'}], 'interventions': [{'name': 'Orange juice (500 mL/d)', 'type': 'OTHER', '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.", 'armGroupLabels': ['Orange juice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14800-903', 'city': 'Araraquara', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Sao Paulo State University "Julio de Mesquita Filho"', 'geoPoint': {'lat': -21.79444, 'lon': -48.17556}}], 'overallOfficials': [{'name': 'Thais B Cesar, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sao Paulo State University "Julio de Mesquita Filho"'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'São Paulo State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Thais Cesar', 'investigatorAffiliation': 'São Paulo State University'}}}}