<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03026569</url>
  </required_header>
  <id_info>
    <org_study_id>SaoPSU11</org_study_id>
    <nct_id>NCT03026569</nct_id>
  </id_info>
  <brief_title>Orange Juice Consumption in Patients With Hepatitis C</brief_title>
  <official_title>Orange Juice as Dietary Source of Antioxidants for Patients With Hepatitis C Under Antiviral Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>São Paulo State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>São Paulo State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to verify whether orange juice, source of citrus flavonoids and vitamin C,&#xD;
      may contribute to the treatment of patients with chronic hepatitis C.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Forty-three patients with chronic hepatitis C who were being treated with pegylated&#xD;
      interferon combined with ribavirin, according to the Clinical Protocol and Therapeutic&#xD;
      Guidelines for Viral Hepatitis C and Co-infections of the Brazilian Health Ministry were&#xD;
      randomly divided into two parallel groups: (1) orange juice (n = 23), which were supplemented&#xD;
      with orange juice (500 mL/d) for 8 weeks; (2) control group (n = 20) composed of patients&#xD;
      that were not drinking orange juice regularly. The recruitment process began in February&#xD;
      2012, the intervention was carried out from May 2012 to July 2012, and the data analysis&#xD;
      started in September 2012. The sample number took into account variances on total cholesterol&#xD;
      with a type I error α = 0.05 and a type II error β = 0.2 (80% power) (Dourado et al., 2015).&#xD;
      The minimum sample size should have 20 individuals per group (n = 40), considering an&#xD;
      approximately 15% dropout rate. Primary and secondary endpoints were the reduction of total&#xD;
      cholesterol and modification of biochemical markers, respectively. Kolmogorov Smirnov and&#xD;
      Levene test assessed normality and homogeneity of data, respectively. Assessment of the data&#xD;
      was performed in all participants on the first and last day of the experiment. All the&#xD;
      parameters were compared between the juice group and the control group using General Linear&#xD;
      Model of Repeated Measures Analysis. Differences in baseline patients' characteristics&#xD;
      between the two groups were analyzed by One-way analysis of variance (ANOVA). The LSD signed&#xD;
      rank post-test was used to assess significant changes in parameters after the start of&#xD;
      treatment in each group, and the differences were considered statistically significant at p &lt;&#xD;
      0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body mass</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% body fat</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HOMA-IR</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-C</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-C</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>alkaline phosphatase</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AST</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ALT</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gamma-GT</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TBARS</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ABTS</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Chronic Infection</condition>
  <arm_group>
    <arm_group_label>Orange juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Orange juice (500 mL/d)</intervention_name>
    <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.</description>
    <arm_group_label>Orange juice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Detection of circulating HCV RNA&#xD;
&#xD;
          -  Negative HBV surface antigen&#xD;
&#xD;
          -  Negative antibodies to HIV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Co-infection with hepatitis B virus (HBV)&#xD;
&#xD;
          -  Co-infection with hepatitis A virus (HAV)&#xD;
&#xD;
          -  Co-infection with human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Presence of diabetes mellitus,&#xD;
&#xD;
          -  Presence of ascites&#xD;
&#xD;
          -  Elevation in serum ferritin levels&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thais B Cesar, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sao Paulo State University &quot;Julio de Mesquita Filho&quot;</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sao Paulo State University &quot;Julio de Mesquita Filho&quot;</name>
      <address>
        <city>Araraquara</city>
        <state>Sao Paulo</state>
        <zip>14800-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>26490535</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>São Paulo State University</investigator_affiliation>
    <investigator_full_name>Thais Cesar</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>orange juice</keyword>
  <keyword>chronic hepatitis C</keyword>
  <keyword>biochemical markers</keyword>
  <keyword>oxidative stress</keyword>
  <keyword>nutritional status</keyword>
  <keyword>antioxidants</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Persistent Infection</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03026569
org study id: SaoPSU11
nct id: NCT03026569
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Total cholesterol
time frame: 8 weeks
measure: Body mass
time frame: 8 weeks
measure: Body mass index
time frame: 8 weeks
measure: % body fat
time frame: 8 weeks
measure: Waist circumference
time frame: 8 weeks
measure: Glucose
time frame: 8 weeks
measure: Insulin
time frame: 8 weeks
measure: HOMA-IR
time frame: 8 weeks
measure: LDL-C
time frame: 8 weeks
measure: HDL-C
time frame: 8 weeks
measure: Triglycerides
time frame: 8 weeks
measure: CRP
time frame: 8 weeks
measure: alkaline phosphatase
time frame: 8 weeks
measure: AST
time frame: 8 weeks
measure: ALT
time frame: 8 weeks
measure: gamma-GT
time frame: 8 weeks
measure: TBARS
time frame: 8 weeks
measure: ABTS
time frame: 8 weeks
arm group label: Orange juice
arm group type: Experimental
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 group label: Control
arm group type: No Intervention
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: Orange juice (500 mL/d)
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.
arm group label: Orange juice
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Thais B Cesar, Ph.D
role: Principal Investigator
affiliation: Sao Paulo State University "Julio de Mesquita Filho"
facility: 
country: Brazil
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.
PMID: 26490535
responsible party type: Principal Investigator
investigator affiliation: São Paulo State University
investigator full name: Thais Cesar
investigator title: PhD
mesh term: Hepatitis C
mesh term: Persistent Infection
mesh term: Hepatitis