<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/NCT03032120</url>
  </required_header>
  <id_info>
    <org_study_id>SaoPSU17</org_study_id>
    <nct_id>NCT03032120</nct_id>
  </id_info>
  <brief_title>Postprandial Response of Fresh-squeezed and Processed Orange Juice of Lean and Obese Subjects</brief_title>
  <official_title>Postprandial Response of Fresh-squeezed and Processed Orange Juice on Appetite-related Biomarkers and Antioxidant-status in Lean and Obese Subjects</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed investigated the acute intake effect of fresh-squeezed orange juice (FOJ),&#xD;
      processed orange juice (POJ), and an isoenergetic orange-flavored drink (control) on&#xD;
      postprandial response of blood serum biomarkers (glucose, insulin, leptin and adiponectin),&#xD;
      anti-oxidatant status, and prospective food intake in lean and obese subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-randomized crossover clinical trial, in which eligible participants (n= 36) were&#xD;
      allocated in accordance with their body mass index in two groups, lean (n = 18, 9 women/9&#xD;
      men) and obese (n = 18, 9 women/9 men). Subjects of both groups intake of one single dose (5&#xD;
      mL/kg body weight) of isoenergetic beverages in three different phases: (1) fresh-squeezed&#xD;
      orange juice (FOJ), (2) commercial processed orange juice (POJ) and (3) an energy and&#xD;
      sugars-matched orange-flavored drink (control), with a washout period of seven days among&#xD;
      each beverage. Thirty minutes after the intake of each beverage, the participants had a&#xD;
      flavonoid-free standard breakfast, which contained coffee (infusion), milk, sugar or&#xD;
      sweetener, white bread sandwich with lean ham and light cream cheese, salted and sweet&#xD;
      biscuits. Posteriorly, blood samples (10 mL) were collected at 30, 60, 120 and 300 min after&#xD;
      each intervention with a catheter installed in a vein of the arm. After blood collection, the&#xD;
      volunteers were instructed to record all meals throughout the day, noting the amount eaten of&#xD;
      each food. The sample number took into account variations in blood serum glucose with a type&#xD;
      I error α = 0.05 and a type II error β = 0.2 (80% power). Primary output were the&#xD;
      modification on glucose or insulin concentration induced by different beverages in some point&#xD;
      of the curves. The secondary output was the antioxidant activity induced by FOJ and/or POJ.&#xD;
      Kolmogorov Smirnov and Levene test, respectively assessed normality and homogeneity of the&#xD;
      data. Area under the curve (AUC0-300 min) was calculated by the clearance of the appetite&#xD;
      related-biomarkers (glucose, insulin, leptin and adiponectin) during 300 min for each trial&#xD;
      phase Other parameters, as maximum concentration (Cmax), and time to reach maximum blood&#xD;
      concentration (Tmax) were also estimated. AUC was determined with the trapezoidal method by&#xD;
      Microcal Software Inc., Origin® 6.0. One-way analysis of variance (ANOVA) followed by Sidak&#xD;
      post hoc was applied to compared the effect of interventions on appetite related-biomarkers,&#xD;
      anti-oxidant status and beverage composition. P significance was set up ≤ 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of the changes on glucose, insulin, leptin, and adiponectin levels over the time times 0, 30, 60, 120, and 300 min</measure>
    <time_frame>Up to 6 month after blood collection of glucose, insulin, leptin, and adiponectin.</time_frame>
    <description>Determination of glucose, insulin, leptin, adiponectin in the blood serum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the changes on blood serum antioxidant biomarkers before and after each beverage intervention</measure>
    <time_frame>Up to 6 month after blood collection of antioxidant biomarkers (TBARS and ABTS).</time_frame>
    <description>Determination of TBARS and ABTS in the blood serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing of change on prospective food intake after each beverage intervention</measure>
    <time_frame>Up to 3 weeks after the application of each 24-h food recall.</time_frame>
    <description>Evaluation of prospective food intake by 24-h food recall.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Fresh orange juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: The subjects drank 5 mL/kg body weight of fresh-squeezed orange juice (FOJ).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Processed orange juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: The subjects drank 5 mL/kg body weight of processed orange juice (POJ).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects drank 5 mL/kg body weight of control drink compounded by water mixed with sugars in a similar concentration of orange juices (5.2% of sucrose, 2.5% of fructose, 2.1% of glucose, 0.75% of citric acid, and malic acid 0.25%, flavored and colored with some drops of orange essence).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Orange juice</intervention_name>
    <description>Lean and obese subjects drank one single dose (5 mL/kg body weight) of fresh-squeezed orange juice (FOJ) and processed orange juice (POJ) followed by an ad libitum breakfast. A washout period of seven days among each beverage (FOJ, POJ and control) was applied.</description>
    <arm_group_label>Fresh orange juice</arm_group_label>
    <arm_group_label>Processed orange juice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Lean and obese subjects drank one single dose (5 mL/kg body weight) of an energy and sugars-matched orange-flavored drink (control), followed by an ad libitum breakfast. A washout period of seven days among each beverage (FOJ, POJ and control) was applied.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy men and women volunteers;&#xD;
&#xD;
          2. Volunteers with BMI between 18.5 to 39.9 kg/m2.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Volunteers with BMI between more than 40 kg/m2;&#xD;
&#xD;
          2. Smokers volunteers;&#xD;
&#xD;
          3. Volunteers who are in treatment with drugs (except contraceptives), vitamins and&#xD;
             nutritional supplements;&#xD;
&#xD;
          4. Volunteers who are dieting for weight loss;&#xD;
&#xD;
          5. Volunteers who gained or lost more than 3 kg of weight in the last 3 months;&#xD;
&#xD;
          6. Volunteers who consume more than 20 g of alcohol per day&#xD;
&#xD;
          7. Volunteers who practicing intense physical activity (more than 5 hours per week).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.</citation>
    <PMID>11234459</PMID>
  </results_reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There was no plan to share individual participant data (IPD) to other researchers.</ipd_description>
  </patient_data>
  <!-- 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/NCT03032120
org study id: SaoPSU17
nct id: NCT03032120
lead sponsor: 
has dmc: Yes
This study aimed investigated the acute intake effect of fresh-squeezed orange juice (FOJ),
      processed orange juice (POJ), and an isoenergetic orange-flavored drink (control) on
      postprandial response of blood serum biomarkers (glucose, insulin, leptin and adiponectin),
      anti-oxidatant status, and prospective food intake in lean and obese subjects.
Non-randomized crossover clinical trial, in which eligible participants (n= 36) were
      allocated in accordance with their body mass index in two groups, lean (n = 18, 9 women/9
      men) and obese (n = 18, 9 women/9 men). Subjects of both groups intake of one single dose (5
      mL/kg body weight) of isoenergetic beverages in three different phases: (1) fresh-squeezed
      orange juice (FOJ), (2) commercial processed orange juice (POJ) and (3) an energy and
      sugars-matched orange-flavored drink (control), with a washout period of seven days among
      each beverage. Thirty minutes after the intake of each beverage, the participants had a
      flavonoid-free standard breakfast, which contained coffee (infusion), milk, sugar or
      sweetener, white bread sandwich with lean ham and light cream cheese, salted and sweet
      biscuits. Posteriorly, blood samples (10 mL) were collected at 30, 60, 120 and 300 min after
      each intervention with a catheter installed in a vein of the arm. After blood collection, the
      volunteers were instructed to record all meals throughout the day, noting the amount eaten of
      each food. The sample number took into account variations in blood serum glucose with a type
      I error α = 0.05 and a type II error β = 0.2 (80% power). Primary output were the
      modification on glucose or insulin concentration induced by different beverages in some point
      of the curves. The secondary output was the antioxidant activity induced by FOJ and/or POJ.
      Kolmogorov Smirnov and Levene test, respectively assessed normality and homogeneity of the
      data. Area under the curve (AUC0-300 min) was calculated by the clearance of the appetite
      related-biomarkers (glucose, insulin, leptin and adiponectin) during 300 min for each trial
      phase Other parameters, as maximum concentration (Cmax), and time to reach maximum blood
      concentration (Tmax) were also estimated. AUC was determined with the trapezoidal method by
      Microcal Software Inc., Origin® 6.0. One-way analysis of variance (ANOVA) followed by Sidak
      post hoc was applied to compared the effect of interventions on appetite related-biomarkers,
      anti-oxidant status and beverage composition. P significance was set up ≤ 0.05.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Assessment of the changes on glucose, insulin, leptin, and adiponectin levels over the time times 0, 30, 60, 120, and 300 min
time frame: Up to 6 month after blood collection of glucose, insulin, leptin, and adiponectin.
description: Determination of glucose, insulin, leptin, adiponectin in the blood serum.
measure: Assessment of the changes on blood serum antioxidant biomarkers before and after each beverage intervention
time frame: Up to 6 month after blood collection of antioxidant biomarkers (TBARS and ABTS).
description: Determination of TBARS and ABTS in the blood serum.
measure: Assessing of change on prospective food intake after each beverage intervention
time frame: Up to 3 weeks after the application of each 24-h food recall.
description: Evaluation of prospective food intake by 24-h food recall.
arm group label: Fresh orange juice
arm group type: Experimental
description: Intervention: The subjects drank 5 mL/kg body weight of fresh-squeezed orange juice (FOJ).
arm group label: Processed orange juice
arm group type: Experimental
description: Intervention: The subjects drank 5 mL/kg body weight of processed orange juice (POJ).
arm group label: Control
arm group type: Experimental
description: The subjects drank 5 mL/kg body weight of control drink compounded by water mixed with sugars in a similar concentration of orange juices (5.2% of sucrose, 2.5% of fructose, 2.1% of glucose, 0.75% of citric acid, and malic acid 0.25%, flavored and colored with some drops of orange essence).
intervention type: Dietary Supplement
intervention name: Orange juice
description: Lean and obese subjects drank one single dose (5 mL/kg body weight) of fresh-squeezed orange juice (FOJ) and processed orange juice (POJ) followed by an ad libitum breakfast. A washout period of seven days among each beverage (FOJ, POJ and control) was applied.
arm group label: Fresh orange juice
arm group label: Processed orange juice
intervention type: Dietary Supplement
intervention name: Control
description: Lean and obese subjects drank one single dose (5 mL/kg body weight) of an energy and sugars-matched orange-flavored drink (control), followed by an ad libitum breakfast. A washout period of seven days among each beverage (FOJ, POJ and control) was applied.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
PMID: 11234459
responsible party type: Principal Investigator
investigator affiliation: São Paulo State University
investigator full name: Thais Cesar
investigator title: PhD
sharing ipd: No
ipd description: There was no plan to share individual participant data (IPD) to other researchers.