<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/NCT03301675</url>
  </required_header>
  <id_info>
    <org_study_id>SaoPSU8</org_study_id>
    <nct_id>NCT03301675</nct_id>
  </id_info>
  <brief_title>Effect of Orange Juice and Healthy Diet on Cardiometabolic Risk Factors of Individuals With Metabolic Syndrome</brief_title>
  <official_title>Effect of Orange Juice Consumption Associated With Healthy Diet on Cardiometabolic Risk Factors of Individuals With Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>São Paulo State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Association of Exporters of Citrus Juices</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Citrosuco Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>São Paulo State University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to verify if combination of a healthy diet and orange juice consumption can&#xD;
      minimize cardiometabolic risk factors for Metabolic Syndrome (MetS)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical study was parallel, controlled, and randomized with metabolic syndrome subjects&#xD;
      (ATPIII, AHA / NHLA) aimed at the consumption of an energy-balanced balanced diet for 12&#xD;
      weeks and divided into two groups: Control (n = 38): dietary guidance only; and Orange Juice&#xD;
      (n = 38): diet guidance associated with 500 mL / day of 100% whole orange juice. The&#xD;
      recruitment process began in June 2016, the intervention was carried out from September 2016&#xD;
      to December 2016, and the data analysis started in January 2016. The sample number took into&#xD;
      account variances on LDL-C, with a type I error α = 0.05 and a type II error β = 0.2 (80%&#xD;
      power). The minimum sample size should have 32 individuals per group (n = 64). Considering an&#xD;
      approximately 15% dropout rate, the final sample size of study was constituted by 38&#xD;
      individuals per group. Primary and secondary endpoints were the reduction of LDL-C and&#xD;
      modification of the levels of cardiometabolic risk factors, inflammatory and hemodynamics&#xD;
      parameters, respectively. Kolmogorov Smirnov and Levene test assessed normality and&#xD;
      homogeneity of data, respectively. T-test was conducted to identify possible differences&#xD;
      between OJ and control groups at baseline. A linear mixed-effects model was apply to&#xD;
      determine the time effect within and between groups (Sidak post hoc) and P significance was&#xD;
      set up ≤ 0.05. The assessment of body composition, metabolic biomarkers and food intake were&#xD;
      analyzed over a 12-week intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">December 2, 2018</completion_date>
  <primary_completion_date type="Actual">May 2017</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>LDL-C</measure>
    <time_frame>12 weeks</time_frame>
    <description>mg/dL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HDL-C</measure>
    <time_frame>12 weeks</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>12 weeks</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>12 weeks</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circunference</measure>
    <time_frame>12 weeks</time_frame>
    <description>cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure systolic and diastolic</measure>
    <time_frame>12 weeks</time_frame>
    <description>mm Hg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body lean mass</measure>
    <time_frame>12 weeks</time_frame>
    <description>kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body fat mass</measure>
    <time_frame>12 weeks</time_frame>
    <description>kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body fat</measure>
    <time_frame>12 weeks</time_frame>
    <description>percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visceral fat area</measure>
    <time_frame>12 weeks</time_frame>
    <description>kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin</measure>
    <time_frame>12 weeks</time_frame>
    <description>µU/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>12 weeks</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hsCRP</measure>
    <time_frame>12 weeks</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-6</measure>
    <time_frame>12 weeks</time_frame>
    <description>pg/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TNF-alfa</measure>
    <time_frame>12 weeks</time_frame>
    <description>pg/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICAM</measure>
    <time_frame>12 weeks</time_frame>
    <description>ng/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VCAM</measure>
    <time_frame>12 weeks</time_frame>
    <description>ng/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular risk index</measure>
    <time_frame>12 weeks</time_frame>
    <description>% risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Common carotid artery intima-media thickness - CCA-IMT</measure>
    <time_frame>12 weeks</time_frame>
    <description>mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse wave velocity - PWV</measure>
    <time_frame>12 weeks</time_frame>
    <description>cm/s</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flow-mediated dilatation of the brachial artery - BA-FMD</measure>
    <time_frame>12 weeks</time_frame>
    <description>percentage</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Orange juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Orange Juice: Thirty-eight individuals with MetS were submitted to a healthy diet (energy was based on individual actual weight) plus 100% orange juice (500 mL/d) during 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control: Thirty-eight individuals with MetS were submitted to a healthy diet (energy was based on individual actual weight) during 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Orange Juice (500 mL/d)</intervention_name>
    <description>Nutritionists prescribed the same balanced diet for both groups keeping suffice energy to maintain the current weight, estimated from total energy expenditure (TEE) for each individual and based on individual weight. The dietary plan was composed of six meals/day: breakfast (fat-free milk and coffee; whole-grain bread with margarine, and an apple); snack 1 (250 mL OJ/ banana or other fruits and free-fat yogurt); lunch (brown rice, beans, grilled lean meat, salad, cooked vegetables); snack 2 (250 mL OJ / free-fat yogurt with oatmeal); dinner (brown rice, beans, grilled lean meat, cooked vegetables and salad); and snack 3 (salty crackers or oat cookies, tea without sugar). Body composition measurements were colected every two weeks; blood samples and dietary questionnaires, monthly.</description>
    <arm_group_label>Orange juice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Three or more of the risk factors of MS: (1) waist circumference man ≥ 102 cm and&#xD;
             woman ≥ 88 cm; (2) triglycerides ≥ 150 mg / dL; (3) HDL-C man ≤ 40 mg / dL and woman ≤&#xD;
             50 mg / dL; (4) blood pressure ≥ 130 / ≥ 85 mm Hg and (5) fasting glucose ≥ 100 mg /&#xD;
             dL (common diabetes, high blood pressure);&#xD;
&#xD;
          -  25 ≥ BMI ≤ 39.9 kg / m - overweight to grade II obesity;&#xD;
&#xD;
          -  Like to consume orange juice;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant / nursing;&#xD;
&#xD;
          -  Use of vitamins or vitamin-food supplements in the last three months;&#xD;
&#xD;
          -  Individuals with diseases that require specific diet recommendations such as diabetes&#xD;
             mellitus with insulin therapy and carbohydrate counts, cancer, chronic liver and&#xD;
             kidney disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 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;, Faculdade de Ciências Farmacêuticas</affiliation>
  </overall_official>
  <reference>
    <citation>Silveira JQ, Dourado GK, Cesar TB. Red-fleshed sweet orange juice improves the risk factors for metabolic syndrome. Int J Food Sci Nutr. 2015;66(7):830-6. doi: 10.3109/09637486.2015.1093610.</citation>
    <PMID>26471075</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>March 30, 2023</last_update_submitted>
  <last_update_submitted_qc>March 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2023</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>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Orange juice</keyword>
  <keyword>Healthy diet</keyword>
  <keyword>Metabolic syndrome</keyword>
  <keyword>Cardiometabolic risk factors</keyword>
  <keyword>Body composition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT03301675
org study id: SaoPSU8
nct id: NCT03301675
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study aimed to verify if combination of a healthy diet and orange juice consumption can
      minimize cardiometabolic risk factors for Metabolic Syndrome (MetS)
The clinical study was parallel, controlled, and randomized with metabolic syndrome subjects
      (ATPIII, AHA / NHLA) aimed at the consumption of an energy-balanced balanced diet for 12
      weeks and divided into two groups: Control (n = 38): dietary guidance only; and Orange Juice
      (n = 38): diet guidance associated with 500 mL / day of 100% whole orange juice. The
      recruitment process began in June 2016, the intervention was carried out from September 2016
      to December 2016, and the data analysis started in January 2016. The sample number took into
      account variances on LDL-C, with a type I error α = 0.05 and a type II error β = 0.2 (80%
      power). The minimum sample size should have 32 individuals per group (n = 64). Considering an
      approximately 15% dropout rate, the final sample size of study was constituted by 38
      individuals per group. Primary and secondary endpoints were the reduction of LDL-C and
      modification of the levels of cardiometabolic risk factors, inflammatory and hemodynamics
      parameters, respectively. Kolmogorov Smirnov and Levene test assessed normality and
      homogeneity of data, respectively. T-test was conducted to identify possible differences
      between OJ and control groups at baseline. A linear mixed-effects model was apply to
      determine the time effect within and between groups (Sidak post hoc) and P significance was
      set up ≤ 0.05. The assessment of body composition, metabolic biomarkers and food intake were
      analyzed over a 12-week intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: LDL-C
time frame: 12 weeks
description: mg/dL
measure: HDL-C
time frame: 12 weeks
description: mg/dL
measure: Glucose
time frame: 12 weeks
description: mg/dL
measure: Triglycerides
time frame: 12 weeks
description: mg/dL
measure: Waist circunference
time frame: 12 weeks
description: cm
measure: Blood pressure systolic and diastolic
time frame: 12 weeks
description: mm Hg
measure: Body lean mass
time frame: 12 weeks
description: kg
measure: Body fat mass
time frame: 12 weeks
description: kg
measure: Body fat
time frame: 12 weeks
description: percentage
measure: Visceral fat area
time frame: 12 weeks
description: kg
measure: Insulin
time frame: 12 weeks
description: µU/mL
measure: Total cholesterol
time frame: 12 weeks
description: mg/dL
measure: hsCRP
time frame: 12 weeks
description: mg/dL
measure: IL-6
time frame: 12 weeks
description: pg/ml
measure: TNF-alfa
time frame: 12 weeks
description: pg/ml
measure: ICAM
time frame: 12 weeks
description: ng/mL
measure: VCAM
time frame: 12 weeks
description: ng/mL
measure: Cardiovascular risk index
time frame: 12 weeks
description: % risk
measure: Common carotid artery intima-media thickness - CCA-IMT
time frame: 12 weeks
description: mm
measure: Pulse wave velocity - PWV
time frame: 12 weeks
description: cm/s
measure: Flow-mediated dilatation of the brachial artery - BA-FMD
time frame: 12 weeks
description: percentage
arm group label: Orange juice
arm group type: Experimental
description: Orange Juice: Thirty-eight individuals with MetS were submitted to a healthy diet (energy was based on individual actual weight) plus 100% orange juice (500 mL/d) during 12 weeks.
arm group label: Control
arm group type: No Intervention
description: Control: Thirty-eight individuals with MetS were submitted to a healthy diet (energy was based on individual actual weight) during 12 weeks.
intervention type: Other
intervention name: Orange Juice (500 mL/d)
description: Nutritionists prescribed the same balanced diet for both groups keeping suffice energy to maintain the current weight, estimated from total energy expenditure (TEE) for each individual and based on individual weight. The dietary plan was composed of six meals/day: breakfast (fat-free milk and coffee; whole-grain bread with margarine, and an apple); snack 1 (250 mL OJ/ banana or other fruits and free-fat yogurt); lunch (brown rice, beans, grilled lean meat, salad, cooked vegetables); snack 2 (250 mL OJ / free-fat yogurt with oatmeal); dinner (brown rice, beans, grilled lean meat, cooked vegetables and salad); and snack 3 (salty crackers or oat cookies, tea without sugar). Body composition measurements were colected every two weeks; blood samples and dietary questionnaires, monthly.
arm group label: Orange juice
criteria: 
gender: All
minimum age: 25 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", Faculdade de Ciências Farmacêuticas
citation: Silveira JQ, Dourado GK, Cesar TB. Red-fleshed sweet orange juice improves the risk factors for metabolic syndrome. Int J Food Sci Nutr. 2015;66(7):830-6. doi: 10.3109/09637486.2015.1093610.
PMID: 26471075
responsible party type: Principal Investigator
investigator affiliation: São Paulo State University
investigator full name: Thais Cesar
investigator title: Principal Investigator
mesh term: Metabolic Syndrome
mesh term: Syndrome