<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/NCT03831893</url>
  </required_header>
  <id_info>
    <org_study_id>2019-00980</org_study_id>
    <nct_id>NCT03831893</nct_id>
  </id_info>
  <brief_title>Metabolic Effects of Nopal in Healthy Humans</brief_title>
  <official_title>Evaluation of Potentially Bioactive Foods With Respect to Effects on Metabolic Test Markers and Cognitive Variables</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal is to increase the knowledge that can be used for the development of food&#xD;
      products with anti-diabetic properties, with the purpose to facilitate healthier food choices&#xD;
      for people. More specifically the purpose of this study is to evaluate effects on metabolic&#xD;
      test markers of Nopal (Opuntia) in healthy humans.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study include three visits at the research unit. At two of the visits the test subjects&#xD;
      consume nopal in different doses. At one visit the subjects will consume a reference product.&#xD;
      The intervention products are consumed at breakfast (at 8.00) and metabolic effects are&#xD;
      investigated 3 hours postprandially. Consumption of the intervention products is separated by&#xD;
      a one week washout period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 29, 2019</start_date>
  <completion_date type="Actual">August 13, 2019</completion_date>
  <primary_completion_date type="Actual">July 30, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood glucose tolerance</measure>
    <time_frame>3 hours after breakfast (measurements at fasting, at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min and 180 min. Area under the curve is calculated and used in the statistical evaluations)</time_frame>
    <description>Repeated blood glucose determinations in the postprandial period after breakfast. The area under the curve, using incremental changes from baseline, are used in the statistical evaluation to determine glucose tolerance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>subjective appetite sensations</measure>
    <time_frame>3 hours after breakfast (measurements at fasting, at 30 min, 60 min, 90 min, 120 min, 150 min and 180 min. Area under the curve is calculated and used in the statistical evaluations)</time_frame>
    <description>changes in subjective appetite sensations will be registered in the postprandial period at breakfast, using 0 - 100 mm visual analogue scales (VAS scale). The two end points of the scales (i.e. 0 mm and 100 mm) represent the minimum and maximum, respectively, agreement with a appetite sensation. The hunger sensations to measure are: hunger, satiety and desire to eat.The area under the curve are used in the statistical evaluation to determine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>3 hours after breakfast (measurements at fasting, at 30 min, 60 min, 90 min, 120 min, 150 min and 180 min. Mean values are calculated and used in the statistical evaluations)</time_frame>
    <description>Changes in mood parameters (valence and activity) will be registered in the postprandial period after breakfast.The mood measurements will be assessed using the Swedish Core Affect Scale which included three self-reporting rating scales for evaluating valence (unpleasantness-pleasantness) and for activation (quietness-excitement), respectively. The subjective mood ratings are registered using 0 mm-100 mm VAS. The two end points of the scales (i.e. 0 mm and 100 mm) represent the minimum and maximum, respectively, agreement with a sensation to be rated.The valence rating is assessed by obtaining a mean rating of three scales graded from displeased-pleased, sad-glad and depressed-happy, respectively, and the rating of activation is assessed by obtaining a mean rating of three scales graded from sleepy-awake, passive-active and dull-peppy, respectively.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>A food product similar to the test products but without nopal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nopal food product 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Food product with Nopal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nopal food product 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Food product with Nopal</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nopal food product 1</intervention_name>
    <description>Dried Nopal incorporated in a food product</description>
    <arm_group_label>Nopal food product 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nopal food product 2</intervention_name>
    <description>Dried Nopal incorporated in a food product</description>
    <arm_group_label>Nopal food product 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control</intervention_name>
    <description>Food Product without nopal</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy men and women (non-smokers), BMI 18,5-30 kg/m2, and with no known metabolic&#xD;
        disorders or food allergies will be recruited to the studies. The test subjects should&#xD;
        consume a normal diet in accordance with the Nordic Nutrition Recommendations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Fasting blood glucose &gt;6.1 mmol/L. Metabolic diseases or conditions. Food allergies or&#xD;
        gastro- intestinal conditions. Consumption of probiotics, antibiotics or other drugs..&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Food Technology, engineering and Nutrition, LTH, Lund University</name>
      <address>
        <city>Lund</city>
        <zip>22100</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>October 18, 2019</last_update_submitted>
  <last_update_submitted_qc>October 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2019</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>Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03831893
org study id: 2019-00980
nct id: NCT03831893
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall goal is to increase the knowledge that can be used for the development of food
      products with anti-diabetic properties, with the purpose to facilitate healthier food choices
      for people. More specifically the purpose of this study is to evaluate effects on metabolic
      test markers of Nopal (Opuntia) in healthy humans.
The study include three visits at the research unit. At two of the visits the test subjects
      consume nopal in different doses. At one visit the subjects will consume a reference product.
      The intervention products are consumed at breakfast (at 8.00) and metabolic effects are
      investigated 3 hours postprandially. Consumption of the intervention products is separated by
      a one week washout period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Blood glucose tolerance
time frame: 3 hours after breakfast (measurements at fasting, at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min and 180 min. Area under the curve is calculated and used in the statistical evaluations)
description: Repeated blood glucose determinations in the postprandial period after breakfast. The area under the curve, using incremental changes from baseline, are used in the statistical evaluation to determine glucose tolerance.
measure: subjective appetite sensations
time frame: 3 hours after breakfast (measurements at fasting, at 30 min, 60 min, 90 min, 120 min, 150 min and 180 min. Area under the curve is calculated and used in the statistical evaluations)
description: changes in subjective appetite sensations will be registered in the postprandial period at breakfast, using 0 - 100 mm visual analogue scales (VAS scale). The two end points of the scales (i.e. 0 mm and 100 mm) represent the minimum and maximum, respectively, agreement with a appetite sensation. The hunger sensations to measure are: hunger, satiety and desire to eat.The area under the curve are used in the statistical evaluation to determine
measure: Mood
time frame: 3 hours after breakfast (measurements at fasting, at 30 min, 60 min, 90 min, 120 min, 150 min and 180 min. Mean values are calculated and used in the statistical evaluations)
description: Changes in mood parameters (valence and activity) will be registered in the postprandial period after breakfast.The mood measurements will be assessed using the Swedish Core Affect Scale which included three self-reporting rating scales for evaluating valence (unpleasantness-pleasantness) and for activation (quietness-excitement), respectively. The subjective mood ratings are registered using 0 mm-100 mm VAS. The two end points of the scales (i.e. 0 mm and 100 mm) represent the minimum and maximum, respectively, agreement with a sensation to be rated.The valence rating is assessed by obtaining a mean rating of three scales graded from displeased-pleased, sad-glad and depressed-happy, respectively, and the rating of activation is assessed by obtaining a mean rating of three scales graded from sleepy-awake, passive-active and dull-peppy, respectively.
arm group label: Control
arm group type: Sham Comparator
description: A food product similar to the test products but without nopal
arm group label: Nopal food product 1
arm group type: Experimental
description: Food product with Nopal
arm group label: Nopal food product 2
arm group type: Experimental
description: Food product with Nopal
intervention type: Other
intervention name: Nopal food product 1
description: Dried Nopal incorporated in a food product
arm group label: Nopal food product 1
intervention type: Other
intervention name: Nopal food product 2
description: Dried Nopal incorporated in a food product
arm group label: Nopal food product 2
intervention type: Other
intervention name: control
description: Food Product without nopal
arm group label: Control
criteria: 
gender: All
minimum age: 19 Years
maximum age: 40 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: Associate Professor
sharing ipd: No