<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/NCT02243956</url>
  </required_header>
  <id_info>
    <org_study_id>AFC-2013/619</org_study_id>
    <nct_id>NCT02243956</nct_id>
  </id_info>
  <brief_title>Effects on Cognitive Functions and Mood of Food Products Rich in Polyphenols</brief_title>
  <official_title>Food Design for Improved Cognitive Performance/Effects on Cognitive Functions and Mood of Food Products Rich in Polyphenols</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Anti-Diabetic Food Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lund University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate effects of a selected food product rich in&#xD;
      polyphenol on cognitive performance and mood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The metabolic syndrome (MetS) includes a cluster of dysfunctions that identifies subjects at&#xD;
      risk of developing type-2 diabetes and cardiovascular disease (CVD). A key feature appears to&#xD;
      be chronic increased inflammation and activation of the innate system. Consequently,&#xD;
      increased low-grade inflammation has been connected to adverse effects on insulin&#xD;
      sensitivity, glucose- and lipid metabolism, and blood pressure, and circulating markers of&#xD;
      inflammation such as IL-6. A growing body of evidence also link low-grade inflammation to&#xD;
      poorer cognitive functioning. Type 2 diabetes, MetS, and glucose intolerance are increasingly&#xD;
      being associated with impaired cognition.&#xD;
&#xD;
      Dietary patterns which promote sub-clinical inflammation are increasingly being considered&#xD;
      predictive of future risk of CVD and type-2 diabetes. Epidemiological data shows that a high&#xD;
      consumption of vegetables and fruits is associated with a lowered risk of cancer and&#xD;
      cardiovascular disease, which may be due to the high concentrations of polyphenols or other&#xD;
      anti-oxidants that are found in such foods.&#xD;
&#xD;
      In the presently described project it is hypothesized that four weeks daily consumption of a&#xD;
      product specific high in flavanols can improve metabolic risk variables and cognitive&#xD;
      functions in healthy subjects.&#xD;
&#xD;
      The purpose is therefore to investigate effects of flavanols on cognitive functions and&#xD;
      cardiometabolic risk, and to investigate relations between cardiometabolic risk markers and&#xD;
      cognitive performance. The test product is a commonly used food product, known to be&#xD;
      specifically rich in flavanols. The effects of the test product is compared with effects of a&#xD;
      control product that is based on a similar food product but is lacking flavanols.&#xD;
&#xD;
      Test parameters:&#xD;
&#xD;
      Cognitive tests: Working memory tests (an oral test), selection attention test (measure also&#xD;
      reaction time, a computerized test ), and stroop test (a computerized test.&#xD;
&#xD;
      Mood is determined for 6 different mood sensations using VAS scales.&#xD;
&#xD;
      Bio markers in blood: glucose regulation (glucose, insulin), markers of inflammation and&#xD;
      oxidative stress (IL-6, MDA, oxLDL), blood lipids (total cholesterol, LDL-cholesterol,&#xD;
      HDL-cholesterol, triglycerides), vascular function (P-Selectin, PAI-1, NO), gut hormones&#xD;
      involved in metabolism and satiety (PYY, GLP-1) gut hormon involved in mucosa integrity&#xD;
      (GLP-2), markers of brain function (BDNF, neurotensin).&#xD;
&#xD;
      Blood pressure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>working memory (WM) capacity</measure>
    <time_frame>Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, working memory capacity is determined four times in the postprandial phase up to 3.5h after breakfast.</time_frame>
    <description>The test food product or control is consumed fasting, and after 30 min a standardised breakfast is served. WM tests are performed at 60 min, 120 min, 165 min and 210 min after commencing the intake of test Product. One test takes approximately 8 min to carry out.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mood assessment</measure>
    <time_frame>Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, subjects registered mood sensations at fasting and five times in the postprandial phase up to 3,5h after breakfast.</time_frame>
    <description>Self-reported sensations of mood and feelings of activation was assessed with a modified bipolar variant of the Swedish Core Affect Scales (SCAS) comprising six rating scales of two orthogonal dimensions of core affect: valence (unpleasantness-pleasantness) and activation (quietness-excitement).&#xD;
Mood scales are filled out at fasting, prior to the standardised breakfast served after 30 min and directly after cognitive tests started at 60 min, 120 min, 165 min and 210 min after commencing the intake of test product.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>blood pressure</measure>
    <time_frame>Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood pressure is determined at fasting and four times in the postprandial phase up to 3,5h after breakfast.</time_frame>
    <description>Blood pressure is determined at fasting and at 60 min, 90 min, 150 min and 180 min, prior to other test variables collected at the same test Point.</description>
  </other_outcome>
  <other_outcome>
    <measure>glucose regulation</measure>
    <time_frame>Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood glucose is determined fasting and then eight times in the postprandial phase up to 3.5h after the standardised breakfast</time_frame>
    <description>Blood glucose concentrations (determined in capillary blood), and insulin (determined in venous blood). Blood tests are collected repeatedly during 3h after a standardised breakfast consumed 30 min after commencing the test product/Control Product.</description>
  </other_outcome>
  <other_outcome>
    <measure>selective attention (SA)</measure>
    <time_frame>Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, selective attention is determined three times in the postprandial phase up to 3.5h after the standardised breakfast</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Vascular function</measure>
    <time_frame>Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, vascular marker is determined fasting and up to 3.5h after the standardised breakfast</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Blood lipids</measure>
    <time_frame>Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood lipids are determined fasting and up to 3.5h after the standardised breakfast</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Marker of inflammation</measure>
    <time_frame>Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, inflammatory markers in blood are determined fasting and up to 3.5h after the standardised breakfast</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Markers of oxidative stress</measure>
    <time_frame>Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, markers of oxidative stress are determined in blood at fasting and then up to 3.5h after a standised breakfast</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Gut peptides</measure>
    <time_frame>Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, gut peptides are determined in blood at fasting</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>markers of brain function</measure>
    <time_frame>Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, markers of brain finction are determined in blood at fasting</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Stroop test</measure>
    <time_frame>Each of the two intervention periods is 4 weeks. At the first and last day Stroop tests are performed three times after a standardised breakfast up to 3,5h .</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Cognitive Performance</condition>
  <condition>Mood</condition>
  <condition>Cardiometabolic Risk Markers</condition>
  <arm_group>
    <arm_group_label>Flavanol rich food product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A portion of a common flavanol rich food product is consumed daily for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-flavanol food product</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A portion of a product similar to the experimental Product, but instead contains low amounts of flavanol, is consumed Daily for 4 weeks as a control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Flavanol rich food product</intervention_name>
    <description>polyphenol rich test product</description>
    <arm_group_label>Flavanol rich food product</arm_group_label>
    <arm_group_label>Non-flavanol food product</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy women and men&#xD;
&#xD;
          -  Between 50-70 years&#xD;
&#xD;
          -  BMI 19-25&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metabolic diseases&#xD;
&#xD;
          -  Food allergies&#xD;
&#xD;
          -  Smoker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lund Univercity, Medicon village, Functional Food Science Centre</name>
      <address>
        <city>Lund</city>
        <zip>223 81</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lund University</investigator_affiliation>
    <investigator_full_name>Anne Nilsson</investigator_full_name>
    <investigator_title>PhD, Associate Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT02243956
org study id: AFC-2013/619
nct id: NCT02243956
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate effects of a selected food product rich in
      polyphenol on cognitive performance and mood.
The metabolic syndrome (MetS) includes a cluster of dysfunctions that identifies subjects at
      risk of developing type-2 diabetes and cardiovascular disease (CVD). A key feature appears to
      be chronic increased inflammation and activation of the innate system. Consequently,
      increased low-grade inflammation has been connected to adverse effects on insulin
      sensitivity, glucose- and lipid metabolism, and blood pressure, and circulating markers of
      inflammation such as IL-6. A growing body of evidence also link low-grade inflammation to
      poorer cognitive functioning. Type 2 diabetes, MetS, and glucose intolerance are increasingly
      being associated with impaired cognition.

      Dietary patterns which promote sub-clinical inflammation are increasingly being considered
      predictive of future risk of CVD and type-2 diabetes. Epidemiological data shows that a high
      consumption of vegetables and fruits is associated with a lowered risk of cancer and
      cardiovascular disease, which may be due to the high concentrations of polyphenols or other
      anti-oxidants that are found in such foods.

      In the presently described project it is hypothesized that four weeks daily consumption of a
      product specific high in flavanols can improve metabolic risk variables and cognitive
      functions in healthy subjects.

      The purpose is therefore to investigate effects of flavanols on cognitive functions and
      cardiometabolic risk, and to investigate relations between cardiometabolic risk markers and
      cognitive performance. The test product is a commonly used food product, known to be
      specifically rich in flavanols. The effects of the test product is compared with effects of a
      control product that is based on a similar food product but is lacking flavanols.

      Test parameters:

      Cognitive tests: Working memory tests (an oral test), selection attention test (measure also
      reaction time, a computerized test ), and stroop test (a computerized test.

      Mood is determined for 6 different mood sensations using VAS scales.

      Bio markers in blood: glucose regulation (glucose, insulin), markers of inflammation and
      oxidative stress (IL-6, MDA, oxLDL), blood lipids (total cholesterol, LDL-cholesterol,
      HDL-cholesterol, triglycerides), vascular function (P-Selectin, PAI-1, NO), gut hormones
      involved in metabolism and satiety (PYY, GLP-1) gut hormon involved in mucosa integrity
      (GLP-2), markers of brain function (BDNF, neurotensin).

      Blood pressure.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: working memory (WM) capacity
time frame: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, working memory capacity is determined four times in the postprandial phase up to 3.5h after breakfast.
description: The test food product or control is consumed fasting, and after 30 min a standardised breakfast is served. WM tests are performed at 60 min, 120 min, 165 min and 210 min after commencing the intake of test Product. One test takes approximately 8 min to carry out.
measure: mood assessment
time frame: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, subjects registered mood sensations at fasting and five times in the postprandial phase up to 3,5h after breakfast.
description: Self-reported sensations of mood and feelings of activation was assessed with a modified bipolar variant of the Swedish Core Affect Scales (SCAS) comprising six rating scales of two orthogonal dimensions of core affect: valence (unpleasantness-pleasantness) and activation (quietness-excitement).
Mood scales are filled out at fasting, prior to the standardised breakfast served after 30 min and directly after cognitive tests started at 60 min, 120 min, 165 min and 210 min after commencing the intake of test product.
measure: blood pressure
time frame: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood pressure is determined at fasting and four times in the postprandial phase up to 3,5h after breakfast.
description: Blood pressure is determined at fasting and at 60 min, 90 min, 150 min and 180 min, prior to other test variables collected at the same test Point.
measure: glucose regulation
time frame: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood glucose is determined fasting and then eight times in the postprandial phase up to 3.5h after the standardised breakfast
description: Blood glucose concentrations (determined in capillary blood), and insulin (determined in venous blood). Blood tests are collected repeatedly during 3h after a standardised breakfast consumed 30 min after commencing the test product/Control Product.
measure: selective attention (SA)
time frame: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, selective attention is determined three times in the postprandial phase up to 3.5h after the standardised breakfast
measure: Vascular function
time frame: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, vascular marker is determined fasting and up to 3.5h after the standardised breakfast
measure: Blood lipids
time frame: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood lipids are determined fasting and up to 3.5h after the standardised breakfast
measure: Marker of inflammation
time frame: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, inflammatory markers in blood are determined fasting and up to 3.5h after the standardised breakfast
measure: Markers of oxidative stress
time frame: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, markers of oxidative stress are determined in blood at fasting and then up to 3.5h after a standised breakfast
measure: Gut peptides
time frame: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, gut peptides are determined in blood at fasting
measure: markers of brain function
time frame: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, markers of brain finction are determined in blood at fasting
measure: Stroop test
time frame: Each of the two intervention periods is 4 weeks. At the first and last day Stroop tests are performed three times after a standardised breakfast up to 3,5h .
arm group label: Flavanol rich food product
arm group type: Experimental
description: A portion of a common flavanol rich food product is consumed daily for 4 weeks
arm group label: Non-flavanol food product
arm group type: Placebo Comparator
description: A portion of a product similar to the experimental Product, but instead contains low amounts of flavanol, is consumed Daily for 4 weeks as a control.
intervention type: Other
intervention name: Flavanol rich food product
description: polyphenol rich test product
arm group label: Flavanol rich food product
arm group label: Non-flavanol food product
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Lund University
investigator full name: Anne Nilsson
investigator title: PhD, Associate Professor