<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/NCT03807752</url>
  </required_header>
  <id_info>
    <org_study_id>2018/2163</org_study_id>
    <nct_id>NCT03807752</nct_id>
  </id_info>
  <brief_title>Marin Protein Hydrolysate and Metabolic Syndrome</brief_title>
  <acronym>MPH_MetS</acronym>
  <official_title>The Effect of Supplementation With a Marine Protein Hydrolysate in Patients With Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helse Møre og Romsdal HF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bergen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helse Møre og Romsdal HF</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>
      Overweight and obesity are increasing global health problems and the most important&#xD;
      contributors to morbidity and mortality. The maintenance of long-term weight loss is&#xD;
      difficult, and individuals often regain weight after an intervention program is finished. It&#xD;
      is of interest to find ways to prevent and alleviate metabolic syndrome (MetS), beyond the&#xD;
      known effects of lifestyle modification and weight loss. Fish has been proposed as a food&#xD;
      that may have favorable effects on metabolic health. There is evidence that cod, and other&#xD;
      marine fish, may contain bioactive peptides that have potentially important health effects in&#xD;
      humans. The aim of this study is to investigate the effect of adding a marine protein&#xD;
      hydrolysate (MPH) supplement to the diet over an 8-week period in a group of adults with&#xD;
      established MetS. The investigators expect that this will lead to beneficial changes in the&#xD;
      components of MetS and to an overall healthier metabolic profile.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overweight and obesity are increasing global health problems and the most important&#xD;
      contributors to morbidity and mortality. Obesity (abdominal obesity), together with&#xD;
      hyperglycemia, dyslipidemia and hypertension forms a cluster of risk factors that is called&#xD;
      the metabolic syndrome (MetS). The first-line therapy for MetS is lifestyle intervention -&#xD;
      education on a healthy lifestyle leading to a focus on physical activity and diet, which will&#xD;
      improve risk factors closely linked to MetS. The maintenance of long-term weight loss is&#xD;
      difficult, and individuals often regain weight after an intervention program stops. It is of&#xD;
      interest to find ways to prevent and alleviate MetS, beyond the known effects of lifestyle&#xD;
      modification and weight loss. Fish has been proposed as a food that may have favorable&#xD;
      effects on metabolic health. Previous intervention studies with fish protein in humans and&#xD;
      rodents have shown improved insulin sensitivity and glucose tolerance, reduced cholesterol&#xD;
      levels in plasma and reduced blood pressure. Intervention studies investigating the effect of&#xD;
      cod have mainly focused on the health effect of consuming the whole fillet. Studies on the&#xD;
      remaining part of the fish, the residual material, primarily used for production of animal&#xD;
      feed, are scarce. There is evidence that cod, and other marine fish, may contain bioactive&#xD;
      peptides that have potentially important health effects in humans. Therefore, it is of&#xD;
      interest to investigate the possible effect of a daily supplement of marine protein&#xD;
      hydrolysate (MPH), taken over a longer period, in a group of patients with abnormal glucose&#xD;
      control. The aim of this study is to investigate the effect of adding a MPH supplement to the&#xD;
      diet over an 8-week period in a group of adults with established MetS. The investigators&#xD;
      expect that supplementation with MPH will lead to beneficial changes in the components of&#xD;
      MetS and an overall healthier metabolic profile.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 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>
    <intervention_model_description>A parallel group randomized, controlled clinical trial for eight weeks</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>The provider of the dietary supplement deliver the supplement prepared and packed in equal bags (active/placebo) that we hand out to the participants in an randomized order.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Glucose</measure>
    <time_frame>At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples every 20 minutes (i.e. -15, 0, 20, 40, 60, 80, 100,120 minutes after baseline).</time_frame>
    <description>Postprandial glucose (mmol/L) change at baseline and after 8 weeks on intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insulin</measure>
    <time_frame>At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples every 20 minutes (i.e. -15, 0, 20, 40, 60, 80, 100,120 minutes after baseline).</time_frame>
    <description>Postprandial insulin (mmol/L) change at baseline and after 8 weeks on intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hormon hunger 1</measure>
    <time_frame>At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples (i.e - 15, 0, 20, 40, 80, 120 minutes after baseline).</time_frame>
    <description>Glucagon like peptide 1 (GLP-1) pmol/l at baseline and after 8 weeks on intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hormon hunger 2</measure>
    <time_frame>At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples (i.e - 15, 0, 20, 40, 80, 120 minutes after baseline).</time_frame>
    <description>Ghrelin at baseline and after 8 weeks on intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition 1</measure>
    <time_frame>At baseline and after 8 weeks.</time_frame>
    <description>Bioimpedance at baseline and after 8 weeks on intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition 2</measure>
    <time_frame>At baseline and after 8 weeks.</time_frame>
    <description>Body mass index at baseline and after 8 weeks on intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition 3</measure>
    <time_frame>First at baseline and after 8 weeks.</time_frame>
    <description>Waist circumference at baseline and after 8 weeks on intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose_met</measure>
    <time_frame>At baseline and after 8 weeks.</time_frame>
    <description>Glycated hemoglobin (HBA1c) at baseline and after 8 weeks on intervention.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Inflammation</measure>
    <time_frame>At baseline and after 8 weeks.</time_frame>
    <description>High-sensitive C-reactive protein at baseline and after 8 weeks on intervention.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hormon 2</measure>
    <time_frame>Fasted at baseline and after 8 weeks.</time_frame>
    <description>Adiponectin at baseline and after 8 weeks on intervention.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hormon 1</measure>
    <time_frame>Fasted at baseline and after 8 weeks.</time_frame>
    <description>Leptin at baseline and after 8 weeks on intervention.</description>
  </other_outcome>
  <other_outcome>
    <measure>Lipid profile 1</measure>
    <time_frame>Fasted at baseline and after 8 weeks.</time_frame>
    <description>Triglycerides at baseline and after 8 weeks on intervention.</description>
  </other_outcome>
  <other_outcome>
    <measure>Lipid profile 2</measure>
    <time_frame>Fasted at baseline and after 8 weeks.</time_frame>
    <description>Total cholesterol at baseline and after 8 weeks on intervention.</description>
  </other_outcome>
  <other_outcome>
    <measure>Lipid profile 3</measure>
    <time_frame>Fasted at baseline and after 8 weeks.</time_frame>
    <description>HDL-cholesterol at baseline and after 8 weeks on intervention.</description>
  </other_outcome>
  <other_outcome>
    <measure>Lipid profile 4</measure>
    <time_frame>Fasted at baseline and after 8 weeks.</time_frame>
    <description>LDL-cholesterol at baseline and after 8 weeks on intervention.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>MPH_active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Daily intake at breakfast of supplementary marine protein hydrolysate (MPH). Random sequence of arms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MPH_placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Daily intake at breakfast of supplementary placebo. Random sequence of arms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>MPH_active</intervention_name>
    <description>One daily intake at breakfast of supplementary marine protein hydrolysate (MPH), a dosage of X mg, duration 8 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water. Random sequence of arms.</description>
    <arm_group_label>MPH_active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>MPH_placebo</intervention_name>
    <description>One daily intake at breakfast of supplementary placebo, a dosage of X mg, duration 8 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water.</description>
    <arm_group_label>MPH_placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age 40-70 years&#xD;
&#xD;
          -  BMI 27-35 kg/m2&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  MetS as defined by the presence of at least 3 of the 5 following criteria*:&#xD;
&#xD;
               -  Elevated waist circumference ≥ 94 cm (M), ≥ 80 cm (F)&#xD;
&#xD;
               -  Elevated triglycerides ≥ 1.7 mmol/L (150 mg/dL)&#xD;
&#xD;
               -  Elevated fasting glucose ≥ 5.5 mmol/L (100 mg/dL)&#xD;
&#xD;
               -  Elevated blood pressure S ≥ 130 and/or D ≥85 mmHg&#xD;
&#xD;
               -  Reduced HDL-cholesterol &lt; 1.0 mmol/L (40 mg/dL) (M) &lt;1.3 mmol/L (50 mg/dL) (F)&#xD;
&#xD;
                    -  The International Diabetes Foundations (IDF) cut-off points are used.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected allergy against fish or shellfish&#xD;
&#xD;
          -  Acute infections (may be reconsidered for inclusion at a later time)&#xD;
&#xD;
          -  Chronic disease or therapies that is likely to interfere with the evaluation study&#xD;
             results&#xD;
&#xD;
          -  Pregnancy, lactation or planning pregnancy during study period&#xD;
&#xD;
          -  Substance misuse&#xD;
&#xD;
          -  Inability or unwillingness to comply with the requirements of study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dag Arne Lihaug Hoff, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Helse Møre og Romsdal Hospital Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ålesund Hospital, Helse Møre og Romsdal HF</name>
      <address>
        <city>Ålesund</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Jensen C, Dale HF, Hausken T, Hatlebakk JG, Bronstad I, Lied GA, Hoff DAL. The Effect of Supplementation with Low Doses of a Cod Protein Hydrolysate on Satiety Hormones and Inflammatory Biomarkers in Adults with Metabolic Syndrome: A Randomized, Double-Blind Study. Nutrients. 2020 Nov 8;12(11):3421. doi: 10.3390/nu12113421.</citation>
    <PMID>33171589</PMID>
  </reference>
  <results_reference>
    <citation>Jensen C, Fjeldheim Dale H, Hausken T, Hatlebakk JG, Bronstad I, Lied GA, Hoff DAL. Supplementation with Low Doses of a Cod Protein Hydrolysate on Glucose Regulation and Lipid Metabolism in Adults with Metabolic Syndrome: A Randomized, Double-Blind Study. Nutrients. 2020 Jul 4;12(7):1991. doi: 10.3390/nu12071991.</citation>
    <PMID>32635503</PMID>
  </results_reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>December 21, 2020</last_update_submitted>
  <last_update_submitted_qc>December 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dietary Supplements</keyword>
  <keyword>Fish Proteins</keyword>
  <keyword>Protein Hydrolysates</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT03807752
org study id: 2018/2163
nct id: NCT03807752
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Overweight and obesity are increasing global health problems and the most important
      contributors to morbidity and mortality. The maintenance of long-term weight loss is
      difficult, and individuals often regain weight after an intervention program is finished. It
      is of interest to find ways to prevent and alleviate metabolic syndrome (MetS), beyond the
      known effects of lifestyle modification and weight loss. Fish has been proposed as a food
      that may have favorable effects on metabolic health. There is evidence that cod, and other
      marine fish, may contain bioactive peptides that have potentially important health effects in
      humans. The aim of this study is to investigate the effect of adding a marine protein
      hydrolysate (MPH) supplement to the diet over an 8-week period in a group of adults with
      established MetS. The investigators expect that this will lead to beneficial changes in the
      components of MetS and to an overall healthier metabolic profile.
Overweight and obesity are increasing global health problems and the most important
      contributors to morbidity and mortality. Obesity (abdominal obesity), together with
      hyperglycemia, dyslipidemia and hypertension forms a cluster of risk factors that is called
      the metabolic syndrome (MetS). The first-line therapy for MetS is lifestyle intervention -
      education on a healthy lifestyle leading to a focus on physical activity and diet, which will
      improve risk factors closely linked to MetS. The maintenance of long-term weight loss is
      difficult, and individuals often regain weight after an intervention program stops. It is of
      interest to find ways to prevent and alleviate MetS, beyond the known effects of lifestyle
      modification and weight loss. Fish has been proposed as a food that may have favorable
      effects on metabolic health. Previous intervention studies with fish protein in humans and
      rodents have shown improved insulin sensitivity and glucose tolerance, reduced cholesterol
      levels in plasma and reduced blood pressure. Intervention studies investigating the effect of
      cod have mainly focused on the health effect of consuming the whole fillet. Studies on the
      remaining part of the fish, the residual material, primarily used for production of animal
      feed, are scarce. There is evidence that cod, and other marine fish, may contain bioactive
      peptides that have potentially important health effects in humans. Therefore, it is of
      interest to investigate the possible effect of a daily supplement of marine protein
      hydrolysate (MPH), taken over a longer period, in a group of patients with abnormal glucose
      control. The aim of this study is to investigate the effect of adding a MPH supplement to the
      diet over an 8-week period in a group of adults with established MetS. The investigators
      expect that supplementation with MPH will lead to beneficial changes in the components of
      MetS and an overall healthier metabolic profile.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A parallel group randomized, controlled clinical trial for eight weeks
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: The provider of the dietary supplement deliver the supplement prepared and packed in equal bags (active/placebo) that we hand out to the participants in an randomized order.
measure: Glucose
time frame: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples every 20 minutes (i.e. -15, 0, 20, 40, 60, 80, 100,120 minutes after baseline).
description: Postprandial glucose (mmol/L) change at baseline and after 8 weeks on intervention.
measure: Insulin
time frame: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples every 20 minutes (i.e. -15, 0, 20, 40, 60, 80, 100,120 minutes after baseline).
description: Postprandial insulin (mmol/L) change at baseline and after 8 weeks on intervention.
measure: Hormon hunger 1
time frame: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples (i.e - 15, 0, 20, 40, 80, 120 minutes after baseline).
description: Glucagon like peptide 1 (GLP-1) pmol/l at baseline and after 8 weeks on intervention.
measure: Hormon hunger 2
time frame: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples (i.e - 15, 0, 20, 40, 80, 120 minutes after baseline).
description: Ghrelin at baseline and after 8 weeks on intervention.
measure: Body composition 1
time frame: At baseline and after 8 weeks.
description: Bioimpedance at baseline and after 8 weeks on intervention.
measure: Body composition 2
time frame: At baseline and after 8 weeks.
description: Body mass index at baseline and after 8 weeks on intervention.
measure: Body composition 3
time frame: First at baseline and after 8 weeks.
description: Waist circumference at baseline and after 8 weeks on intervention.
measure: Glucose_met
time frame: At baseline and after 8 weeks.
description: Glycated hemoglobin (HBA1c) at baseline and after 8 weeks on intervention.
measure: Inflammation
time frame: At baseline and after 8 weeks.
description: High-sensitive C-reactive protein at baseline and after 8 weeks on intervention.
measure: Hormon 2
time frame: Fasted at baseline and after 8 weeks.
description: Adiponectin at baseline and after 8 weeks on intervention.
measure: Hormon 1
time frame: Fasted at baseline and after 8 weeks.
description: Leptin at baseline and after 8 weeks on intervention.
measure: Lipid profile 1
time frame: Fasted at baseline and after 8 weeks.
description: Triglycerides at baseline and after 8 weeks on intervention.
measure: Lipid profile 2
time frame: Fasted at baseline and after 8 weeks.
description: Total cholesterol at baseline and after 8 weeks on intervention.
measure: Lipid profile 3
time frame: Fasted at baseline and after 8 weeks.
description: HDL-cholesterol at baseline and after 8 weeks on intervention.
measure: Lipid profile 4
time frame: Fasted at baseline and after 8 weeks.
description: LDL-cholesterol at baseline and after 8 weeks on intervention.
arm group label: MPH_active
arm group type: Active Comparator
description: Daily intake at breakfast of supplementary marine protein hydrolysate (MPH). Random sequence of arms.
arm group label: MPH_placebo
arm group type: Placebo Comparator
description: Daily intake at breakfast of supplementary placebo. Random sequence of arms.
intervention type: Dietary Supplement
intervention name: MPH_active
description: One daily intake at breakfast of supplementary marine protein hydrolysate (MPH), a dosage of X mg, duration 8 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water. Random sequence of arms.
arm group label: MPH_active
intervention type: Dietary Supplement
intervention name: MPH_placebo
description: One daily intake at breakfast of supplementary placebo, a dosage of X mg, duration 8 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water.
arm group label: MPH_placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Dag Arne Lihaug Hoff, MD, PhD
role: Study Director
affiliation: Helse Møre og Romsdal Hospital Trust
facility: 
facility: 
country: Norway
citation: Jensen C, Dale HF, Hausken T, Hatlebakk JG, Bronstad I, Lied GA, Hoff DAL. The Effect of Supplementation with Low Doses of a Cod Protein Hydrolysate on Satiety Hormones and Inflammatory Biomarkers in Adults with Metabolic Syndrome: A Randomized, Double-Blind Study. Nutrients. 2020 Nov 8;12(11):3421. doi: 10.3390/nu12113421.
PMID: 33171589
citation: Jensen C, Fjeldheim Dale H, Hausken T, Hatlebakk JG, Bronstad I, Lied GA, Hoff DAL. Supplementation with Low Doses of a Cod Protein Hydrolysate on Glucose Regulation and Lipid Metabolism in Adults with Metabolic Syndrome: A Randomized, Double-Blind Study. Nutrients. 2020 Jul 4;12(7):1991. doi: 10.3390/nu12071991.
PMID: 32635503
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Syndrome
sharing ipd: No