<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/NCT01684332</url>
  </required_header>
  <id_info>
    <org_study_id>UNAV-078-2010</org_study_id>
    <nct_id>NCT01684332</nct_id>
  </id_info>
  <brief_title>Postprandial Response to Different Jams</brief_title>
  <official_title>Study of the Effects of Three Strawberry Jams, Differing in Carbohydrate and Antioxidant Content, on Postprandial Response in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinica Universidad de Navarra, Universidad de Navarra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinica Universidad de Navarra, Universidad de Navarra</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the effects of an acute intake of three different&#xD;
      types of strawberry jam, differing in the carbohydrates and antioxidants content, on&#xD;
      postprandial glucose metabolism, lipid profile, antioxidant status and satiety indices, in&#xD;
      healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design: Randomized, postprandial, crossover, double-blind intervention with three arms.&#xD;
&#xD;
      Subjects: Sixteen healthy adults&#xD;
&#xD;
      Product studied: At each arm, participants consume 60g of strawberry jam:&#xD;
&#xD;
        -  High-sugar jam (traditional; HS),&#xD;
&#xD;
        -  Low-sugar jam (without added-sugar; LS),&#xD;
&#xD;
        -  Low-sugar jam including antioxidant extract from strawberry pulp (LSA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">March 2011</completion_date>
  <primary_completion_date type="Actual">December 2010</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma malondialdehyde (MDA) postprandial measure</measure>
    <time_frame>up to 120 minutes</time_frame>
    <description>Plasma MDA measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum glucose postprandial concentration</measure>
    <time_frame>Baseline, 30, 60, 90 and 120 minutes</time_frame>
    <description>Serum Glucose measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum insulin postprandial concentration</measure>
    <time_frame>baseline, 30, 60, 90 and 120 minutes</time_frame>
    <description>Serum insulin measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HOMA insulin resistance index</measure>
    <time_frame>Baseline, 30, 60, 90 and 120 minutes</time_frame>
    <description>HOMA-IR calculated at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum total cholesterol postprandial concentration</measure>
    <time_frame>Baseline, 30, 60, 90 and 120 minutes</time_frame>
    <description>Serum total cholesterol measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum HDL-cholesterol postprandial concentration</measure>
    <time_frame>Baseline, 30, 60, 90 and 120 minutes</time_frame>
    <description>Serum HDL-cholesterol measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum LDL-cholesterol postprandial concentration</measure>
    <time_frame>Baseline, 30, 60, 90 and 120 minutes</time_frame>
    <description>Serum LDL-cholesterol calculated at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Uric Acid postprandial concentration</measure>
    <time_frame>Baseline, 30, 60, 90 and 120 minutes</time_frame>
    <description>Serum Uric Acid measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Glutathione Peroxidase postprandial activity</measure>
    <time_frame>Baseline, 30, 60, 90 and 120 minutes</time_frame>
    <description>Plasma Glutathione Peroxidase activity measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial Plasma Total Antioxidant Capacity</measure>
    <time_frame>Baseline, 30, 60, 90 and 120 minutes</time_frame>
    <description>Plasma Total Antioxidant capacity measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Postprandial</condition>
  <condition>Hyperglycemia, Postprandial</condition>
  <condition>Feeding Behaviors</condition>
  <condition>Antioxidant</condition>
  <condition>Lipid Profile</condition>
  <arm_group>
    <arm_group_label>High Sugar (HS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study of the postprandial effects after consuming 60g of strawberry jam with high sugar content</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Sugar (LS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study of the postprandial effects after consuming 60g of strawberry jam with low sugar content</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Sugar + Antioxidant (LSA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study of the postprandial effects after consuming 60g of strawberry jam with low sugar content and an antioxidant extract from strawberry pulp</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Strawberry Jam</intervention_name>
    <arm_group_label>High Sugar (HS)</arm_group_label>
    <arm_group_label>Low Sugar (LS)</arm_group_label>
    <arm_group_label>Low Sugar + Antioxidant (LSA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult men and women&#xD;
&#xD;
          -  Normal weight or overweight (BMI between 18.5 and 29.9 kg/m2)&#xD;
&#xD;
          -  Age between 20 and 50 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To suffer from any chronic disease related to metabolism,&#xD;
&#xD;
          -  To follow concomitant medications,&#xD;
&#xD;
          -  To follow slimming treatments or hormone replacement therapy,&#xD;
&#xD;
          -  To have any inability to perform the follow-up,&#xD;
&#xD;
          -  Smoking,&#xD;
&#xD;
          -  Known food allergies,&#xD;
&#xD;
          -  Pregnancy, lactation or menopause&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>J. Alfredo Martínez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Navarra</affiliation>
  </overall_official>
  <overall_official>
    <last_name>M. Ángeles Zulet, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Navarra</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marta Cuervo, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Navarra</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Santiago Navas-Carretero, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Navarra</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Idoia Ibero-Baraibar, MsC</last_name>
    <role>Study Chair</role>
    <affiliation>University of Navarra</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nutrition, Food Science and Physiology</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.unav.es</url>
    <description>University of Navarra</description>
  </link>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>September 18, 2012</last_update_submitted>
  <last_update_submitted_qc>September 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinica Universidad de Navarra, Universidad de Navarra</investigator_affiliation>
    <investigator_full_name>Alfredo Martinez</investigator_full_name>
    <investigator_title>Professor of Nutrition and Food Science</investigator_title>
  </responsible_party>
  <keyword>Antioxidant</keyword>
  <keyword>glucose metabolism</keyword>
  <keyword>jam</keyword>
  <keyword>polyphenols</keyword>
  <keyword>postprandial</keyword>
  <keyword>strawberry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperglycemia</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/NCT01684332
org study id: UNAV-078-2010
nct id: NCT01684332
lead sponsor: 
has dmc: No
The aim of this study is to investigate the effects of an acute intake of three different
      types of strawberry jam, differing in the carbohydrates and antioxidants content, on
      postprandial glucose metabolism, lipid profile, antioxidant status and satiety indices, in
      healthy adults.
Study Design: Randomized, postprandial, crossover, double-blind intervention with three arms.

      Subjects: Sixteen healthy adults

      Product studied: At each arm, participants consume 60g of strawberry jam:

        -  High-sugar jam (traditional; HS),

        -  Low-sugar jam (without added-sugar; LS),

        -  Low-sugar jam including antioxidant extract from strawberry pulp (LSA).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Plasma malondialdehyde (MDA) postprandial measure
time frame: up to 120 minutes
description: Plasma MDA measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
measure: Serum glucose postprandial concentration
time frame: Baseline, 30, 60, 90 and 120 minutes
description: Serum Glucose measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
measure: Serum insulin postprandial concentration
time frame: baseline, 30, 60, 90 and 120 minutes
description: Serum insulin measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
measure: HOMA insulin resistance index
time frame: Baseline, 30, 60, 90 and 120 minutes
description: HOMA-IR calculated at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
measure: Serum total cholesterol postprandial concentration
time frame: Baseline, 30, 60, 90 and 120 minutes
description: Serum total cholesterol measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
measure: Serum HDL-cholesterol postprandial concentration
time frame: Baseline, 30, 60, 90 and 120 minutes
description: Serum HDL-cholesterol measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
measure: Serum LDL-cholesterol postprandial concentration
time frame: Baseline, 30, 60, 90 and 120 minutes
description: Serum LDL-cholesterol calculated at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
measure: Serum Uric Acid postprandial concentration
time frame: Baseline, 30, 60, 90 and 120 minutes
description: Serum Uric Acid measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
measure: Plasma Glutathione Peroxidase postprandial activity
time frame: Baseline, 30, 60, 90 and 120 minutes
description: Plasma Glutathione Peroxidase activity measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
measure: Postprandial Plasma Total Antioxidant Capacity
time frame: Baseline, 30, 60, 90 and 120 minutes
description: Plasma Total Antioxidant capacity measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
arm group label: High Sugar (HS)
arm group type: Experimental
description: Study of the postprandial effects after consuming 60g of strawberry jam with high sugar content
arm group label: Low Sugar (LS)
arm group type: Experimental
description: Study of the postprandial effects after consuming 60g of strawberry jam with low sugar content
arm group label: Low Sugar + Antioxidant (LSA)
arm group type: Experimental
description: Study of the postprandial effects after consuming 60g of strawberry jam with low sugar content and an antioxidant extract from strawberry pulp
intervention type: Other
intervention name: Strawberry Jam
arm group label: High Sugar (HS)
arm group label: Low Sugar (LS)
arm group label: Low Sugar + Antioxidant (LSA)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: J. Alfredo Martínez, PhD
role: Principal Investigator
affiliation: University of Navarra
last name: M. Ángeles Zulet, PhD
role: Study Chair
affiliation: University of Navarra
last name: Marta Cuervo, PhD
role: Study Chair
affiliation: University of Navarra
last name: Santiago Navas-Carretero, PhD
role: Study Chair
affiliation: University of Navarra
last name: Idoia Ibero-Baraibar, MsC
role: Study Chair
affiliation: University of Navarra
facility: 
country: Spain
url: http://www.unav.es
description: University of Navarra
responsible party type: Principal Investigator
investigator affiliation: Clinica Universidad de Navarra, Universidad de Navarra
investigator full name: Alfredo Martinez
investigator title: Professor of Nutrition and Food Science
mesh term: Hyperglycemia