<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/NCT03764423</url>
  </required_header>
  <id_info>
    <org_study_id>901420</org_study_id>
    <nct_id>NCT03764423</nct_id>
  </id_info>
  <brief_title>Health Effects of Salmon Fishmeal in Humans</brief_title>
  <acronym>FishMeal</acronym>
  <official_title>Health Effects of Salmon Fishmeal in Humans With Impaired Glucose Tolerance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oslo</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>
      Diabetes contributes significantly to the burden of disease in Norway and cardiovascular&#xD;
      disease is the main cause of mortality.&#xD;
&#xD;
      Both lean and fatty fish are shown to have beneficial health effects. In addition to omega-3&#xD;
      fatty acids, fish contain potential health-promoting components such as taurine, vitamin D,&#xD;
      vitamin B12, iodine, selenium and more unspecified components such as bioactive peptides.&#xD;
      With the expected growth in the aquaculture sector, more protein-rich by-products will become&#xD;
      available.&#xD;
&#xD;
      The overall aim of this project is to investigate the health beneficial effects of fish&#xD;
      protein in the form of salmon fishmeal in a human intervention study with regard to metabolic&#xD;
      risk markers.&#xD;
&#xD;
      We will include subjects with impaired glucose tolerance to a randomized controlled parallel&#xD;
      study. The subjects will receive capsules with fishmeal or placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2018</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>2 hour postprandial blood glucose concentration</measure>
    <time_frame>Change in 2 hour blood glucose concentration from baseline and after 8 weeks between groups</time_frame>
    <description>Glucose concentration measured before and after a standard glucose tolerance test at baseline and after 8 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting blood glucose concentration</measure>
    <time_frame>Change in blood glucose concentration from baseline and after 8 weeks between groups</time_frame>
    <description>Measured at baseline and after 8 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood concentration of insulin</measure>
    <time_frame>Changes in blood insulin concentration from baseline and after 8 weeks between groups</time_frame>
    <description>Blood concentration measured fasting and 2 hours after an oral glucose tolerance test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HOMA-IR</measure>
    <time_frame>Changes in HOMAR-IR from baseline and after 8 weeks between groups</time_frame>
    <description>Blood concentration of insulin x blood concentration of glucose will be used to calculate HOMAR-IR fasting and 2 hours after an oral glucose tolerance test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood concentration of HbA1c</measure>
    <time_frame>Changes in blood HbA1c concentration from baseline and after 8 weeks between groups</time_frame>
    <description>Blood concentration measured fasting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood concentration of incretins (i.e. GLP-1)</measure>
    <time_frame>Changes in blood glucose concentration of increstins from baseline and after 8 weeks between groups</time_frame>
    <description>Blood concentration of incretins measured fasting and 2 hours after oral glucose tolerance test</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Markers related to lipid metabolism</measure>
    <time_frame>Changes in blood concentrations of markers related to lipid metabolism from baseline and after 8 weeks intervensjon</time_frame>
    <description>Blood concentrations of i.e. triglycerides, total-, LDL- and HDL- cholesterol, free fatty acids and lipoprotein subclasses (lipidomics)</description>
  </other_outcome>
  <other_outcome>
    <measure>Markers related to low grade inflammation, including changes in genes expression level in peripheral blood mononuclear cell (PBMCs) in circulation</measure>
    <time_frame>Changes in blood concentrations of markers related to inflammation from baseline and after 8 weeks between groups</time_frame>
    <description>Blood concentrations of i.e. CRP, IL-6</description>
  </other_outcome>
  <other_outcome>
    <measure>Markers related to appetite</measure>
    <time_frame>Changes in blood concentrations of markers related to appetite from baseline and after 8 weeks between groups</time_frame>
    <description>Blood concentrations of gut hormones, i.e. PYY, amylin, leptin</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in PBMC wholegenome transcriptome and untargeted metabolomics</measure>
    <time_frame>Changes in blood concentration of PBMC wholegenome transcriptome and untargeted metabolomics from baseline and after 8 weeks whithin and between groups</time_frame>
    <description>Blood or urine transcriptome and metabolomics</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in markers related to gut microbiota</measure>
    <time_frame>Changes in markers related to gut microbiota between groups from baseline and after 8 weeks intervensjon</time_frame>
    <description>Faecal short-chain fatty acids, bacteria type and diversity</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in blood concentration of micronutrients related to fishintake</measure>
    <time_frame>Changes in blood concentrations of micronutrients related to fishintake between groups from baseline and after 8 weeks intervensjon</time_frame>
    <description>Blood concentrations of i.e. vitamin D, Zn, Se and iodine</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in blood concentration of amino acids</measure>
    <time_frame>Changes in blood concentrations of amino acids between groups postprandially, and between baseline and 8 weeks of intervention</time_frame>
    <description>Blood concentrations of different aminoacids such as i.e valine, isoleucine, leucine</description>
  </other_outcome>
  <other_outcome>
    <measure>Body weight</measure>
    <time_frame>Change between groups from baseline and after 8 weeks intervensjon will be calculated</time_frame>
    <description>Bodyweight (kg) will be used to calculate i.e BMI (kg/m2)</description>
  </other_outcome>
  <other_outcome>
    <measure>Height</measure>
    <time_frame>Change between groups from baseline and after 8 weeks intervensjon will be calculated</time_frame>
    <description>Height (m) will be used to calculate i.e. BMI (kg/m2)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Impaired Glucose Tolerance</condition>
  <arm_group>
    <arm_group_label>Salmon fishmeal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7,5 g fishmeal and 7,5 g microcrytalline cellulose per day in capsules by mounth for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Microcrystalline cellulose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>7,5 g microcrystalline cellulose per day in capsules by mounth for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Salmon fishmeal</intervention_name>
    <description>Salmon fishmeal with high protein content</description>
    <arm_group_label>Salmon fishmeal</arm_group_label>
    <other_name>Fish protein</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Microcrystalline cellulose</intervention_name>
    <description>Microcrystalline cellulose contain no energy and is less fermented in the gut than other dietary fibers.</description>
    <arm_group_label>Microcrystalline cellulose</arm_group_label>
    <other_name>Cellulose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fasting plasma glucose ≥ 5.6 mmol/l or&#xD;
&#xD;
          -  Plasma glucose ≥ 6.5 mmol/l 2h after an OGTT or&#xD;
&#xD;
          -  HbA1c ≥ 5.8 %&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Diabetes (defined as p-glucose ≥ 7.0 mmol/l p-glucose ≥11,1 mmol/l 2h after OGTT or&#xD;
             HbA1c ≥ 6.5 %)&#xD;
&#xD;
          -  High fish intake (&gt; 450 gram/week) or fish allergy&#xD;
&#xD;
          -  Age-related elevated blood pressure (≥ 70 år: ≥ 180/110 mmHg, &gt; 40-70: ≥ 170/100 mmHg&#xD;
             and ≤ 40 år: ≥ 160/100 mmHg)&#xD;
&#xD;
          -  Use of prescription medicines related to diabetes, inflammation, systemic use of&#xD;
             corticosteroids.&#xD;
&#xD;
          -  Non-stable use of lipid lowering drugs, thyroxine, blood pressure lowering drugs,&#xD;
             drugs affecting appetite, dietary supplements (including n-3)&#xD;
&#xD;
          -  High intake of protein supplements powder&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Planning pregnancy or changes in body weight&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kirsten Holven, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Oslo</name>
      <address>
        <city>Oslo</city>
        <state>Post Box 1046, Blindern</state>
        <zip>0317</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Kirsten Holven</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>
  <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/NCT03764423
org study id: 901420
nct id: NCT03764423
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diabetes contributes significantly to the burden of disease in Norway and cardiovascular
      disease is the main cause of mortality.

      Both lean and fatty fish are shown to have beneficial health effects. In addition to omega-3
      fatty acids, fish contain potential health-promoting components such as taurine, vitamin D,
      vitamin B12, iodine, selenium and more unspecified components such as bioactive peptides.
      With the expected growth in the aquaculture sector, more protein-rich by-products will become
      available.

      The overall aim of this project is to investigate the health beneficial effects of fish
      protein in the form of salmon fishmeal in a human intervention study with regard to metabolic
      risk markers.

      We will include subjects with impaired glucose tolerance to a randomized controlled parallel
      study. The subjects will receive capsules with fishmeal or placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 2 hour postprandial blood glucose concentration
time frame: Change in 2 hour blood glucose concentration from baseline and after 8 weeks between groups
description: Glucose concentration measured before and after a standard glucose tolerance test at baseline and after 8 weeks
measure: Fasting blood glucose concentration
time frame: Change in blood glucose concentration from baseline and after 8 weeks between groups
description: Measured at baseline and after 8 weeks.
measure: Blood concentration of insulin
time frame: Changes in blood insulin concentration from baseline and after 8 weeks between groups
description: Blood concentration measured fasting and 2 hours after an oral glucose tolerance test
measure: HOMA-IR
time frame: Changes in HOMAR-IR from baseline and after 8 weeks between groups
description: Blood concentration of insulin x blood concentration of glucose will be used to calculate HOMAR-IR fasting and 2 hours after an oral glucose tolerance test
measure: Blood concentration of HbA1c
time frame: Changes in blood HbA1c concentration from baseline and after 8 weeks between groups
description: Blood concentration measured fasting
measure: Blood concentration of incretins (i.e. GLP-1)
time frame: Changes in blood glucose concentration of increstins from baseline and after 8 weeks between groups
description: Blood concentration of incretins measured fasting and 2 hours after oral glucose tolerance test
measure: Markers related to lipid metabolism
time frame: Changes in blood concentrations of markers related to lipid metabolism from baseline and after 8 weeks intervensjon
description: Blood concentrations of i.e. triglycerides, total-, LDL- and HDL- cholesterol, free fatty acids and lipoprotein subclasses (lipidomics)
measure: Markers related to low grade inflammation, including changes in genes expression level in peripheral blood mononuclear cell (PBMCs) in circulation
time frame: Changes in blood concentrations of markers related to inflammation from baseline and after 8 weeks between groups
description: Blood concentrations of i.e. CRP, IL-6
measure: Markers related to appetite
time frame: Changes in blood concentrations of markers related to appetite from baseline and after 8 weeks between groups
description: Blood concentrations of gut hormones, i.e. PYY, amylin, leptin
measure: Changes in PBMC wholegenome transcriptome and untargeted metabolomics
time frame: Changes in blood concentration of PBMC wholegenome transcriptome and untargeted metabolomics from baseline and after 8 weeks whithin and between groups
description: Blood or urine transcriptome and metabolomics
measure: Changes in markers related to gut microbiota
time frame: Changes in markers related to gut microbiota between groups from baseline and after 8 weeks intervensjon
description: Faecal short-chain fatty acids, bacteria type and diversity
measure: Changes in blood concentration of micronutrients related to fishintake
time frame: Changes in blood concentrations of micronutrients related to fishintake between groups from baseline and after 8 weeks intervensjon
description: Blood concentrations of i.e. vitamin D, Zn, Se and iodine
measure: Changes in blood concentration of amino acids
time frame: Changes in blood concentrations of amino acids between groups postprandially, and between baseline and 8 weeks of intervention
description: Blood concentrations of different aminoacids such as i.e valine, isoleucine, leucine
measure: Body weight
time frame: Change between groups from baseline and after 8 weeks intervensjon will be calculated
description: Bodyweight (kg) will be used to calculate i.e BMI (kg/m2)
measure: Height
time frame: Change between groups from baseline and after 8 weeks intervensjon will be calculated
description: Height (m) will be used to calculate i.e. BMI (kg/m2)
arm group label: Salmon fishmeal
arm group type: Experimental
description: 7,5 g fishmeal and 7,5 g microcrytalline cellulose per day in capsules by mounth for 8 weeks
arm group label: Microcrystalline cellulose
arm group type: Placebo Comparator
description: 7,5 g microcrystalline cellulose per day in capsules by mounth for 8 weeks
intervention type: Dietary Supplement
intervention name: Salmon fishmeal
description: Salmon fishmeal with high protein content
arm group label: Salmon fishmeal
other name: Fish protein
intervention type: Dietary Supplement
intervention name: Microcrystalline cellulose
description: Microcrystalline cellulose contain no energy and is less fermented in the gut than other dietary fibers.
arm group label: Microcrystalline cellulose
other name: Cellulose
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kirsten Holven, Professor
role: Principal Investigator
affiliation: University of Oslo
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Kirsten Holven
investigator title: Professor
mesh term: Glucose Intolerance
sharing ipd: No