<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/NCT04439630</url>
  </required_header>
  <id_info>
    <org_study_id>Protokoll 2018/8-b</org_study_id>
    <nct_id>NCT04439630</nct_id>
  </id_info>
  <brief_title>Effects of Nopal Fractions on Postprandial Glucose Regulation and Appetite Variables in Healthy Humans</brief_title>
  <official_title>Evaluation of Potentially Bioactive Foods With Regard to Their Effects on Cardiometabolic 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postprandial effects of Nopal fractions on glucose and appetite regulation will be&#xD;
      investigated in healthy humans, in a randomised controlled crossover trial&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 1, 2020</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>
    <intervention_model_description>randomised crossover study in healthy young adults with normal BMI</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants knew which test products that were included in the study, but not the consumption order</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>postprandial glucose tolerance</measure>
    <time_frame>0-180 min after start of the meal</time_frame>
    <description>effects on postprandial glucose tolerance after intake of test products at breakfast. Measurements were performed at fasting (time = 0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postprandial insulin concentrations</measure>
    <time_frame>0-180 min</time_frame>
    <description>effects on serum insulin concentrations after intake of test products at breakfast. Measurements were performed at fasting (time = 0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>subjective appetite variables</measure>
    <time_frame>0-180 min</time_frame>
    <description>Subjective appetite variables (hunger, satiety, desire to eat) after intake of test products at breakfast, using a 100 mm Visual Analogue Scale (VAS) on a white paper. Except from a center mark in the center of the scale there was no other visible marks. Measurements were performed at fasting (time = 0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Glucose Tolerance</condition>
  <condition>Appetite Sensations</condition>
  <arm_group>
    <arm_group_label>reference</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Test product without the active components</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nopal fraction 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fraction one out of two possible</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nopal fraction 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fraction two out of two possible</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nopal fractions</intervention_name>
    <description>Nopal flour were divided in two fractions and mixed in two different test breads</description>
    <arm_group_label>Nopal fraction 1</arm_group_label>
    <arm_group_label>Nopal fraction 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Test product without the active components</intervention_name>
    <description>Test product without the active components</description>
    <arm_group_label>reference</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  non-smokers&#xD;
&#xD;
          -  diet accordance with the Nordic Nutrition Recommendations&#xD;
&#xD;
          -  BMI: 18.5-25 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  metabolic disorders&#xD;
&#xD;
          -  food allergies&#xD;
&#xD;
          -  no probiotics or other food /supplement which may interfere with the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Nilsson, assoc. prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lund University</affiliation>
  </overall_official>
  <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 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>October 2, 2020</last_update_submitted>
  <last_update_submitted_qc>October 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2020</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>
  <keyword>healthy subjects</keyword>
  <keyword>diabetes prevention</keyword>
  <keyword>obesity prevention</keyword>
  <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/NCT04439630
org study id: Protokoll 2018/8-b
nct id: NCT04439630
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Postprandial effects of Nopal fractions on glucose and appetite regulation will be
      investigated in healthy humans, in a randomised controlled crossover trial
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: randomised crossover study in healthy young adults with normal BMI
primary purpose: Prevention
masking: Single (Participant)
masking description: Participants knew which test products that were included in the study, but not the consumption order
measure: postprandial glucose tolerance
time frame: 0-180 min after start of the meal
description: effects on postprandial glucose tolerance after intake of test products at breakfast. Measurements were performed at fasting (time = 0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min.
measure: postprandial insulin concentrations
time frame: 0-180 min
description: effects on serum insulin concentrations after intake of test products at breakfast. Measurements were performed at fasting (time = 0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min.
measure: subjective appetite variables
time frame: 0-180 min
description: Subjective appetite variables (hunger, satiety, desire to eat) after intake of test products at breakfast, using a 100 mm Visual Analogue Scale (VAS) on a white paper. Except from a center mark in the center of the scale there was no other visible marks. Measurements were performed at fasting (time = 0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min.
arm group label: reference
arm group type: Sham Comparator
description: Test product without the active components
arm group label: Nopal fraction 1
arm group type: Experimental
description: Fraction one out of two possible
arm group label: Nopal fraction 2
arm group type: Experimental
description: Fraction two out of two possible
intervention type: Dietary Supplement
intervention name: Nopal fractions
description: Nopal flour were divided in two fractions and mixed in two different test breads
arm group label: Nopal fraction 1
arm group label: Nopal fraction 2
intervention type: Dietary Supplement
intervention name: Test product without the active components
description: Test product without the active components
arm group label: reference
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anne Nilsson, assoc. prof.
role: Principal Investigator
affiliation: Lund University
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Lund University
investigator full name: Anne Nilsson
investigator title: Associate professor
sharing ipd: No