xml: <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/NCT06020950</url>
    </required_header>
    <id_info>
      <org_study_id>43005340</org_study_id>
      <nct_id>NCT06020950</nct_id>
    </id_info>
    <brief_title>Chia Seeds Consumption in Hypertriglyceridemia</brief_title>
    <official_title>Effects of Chia Seed Consumption in Comparison With Marine Omega-3 Supplementation on the Concentration of Blood Lipid and Inflammatory Factors in Hypertriglyceridemic Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shahid Beheshti University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Nutrition and Food Technology Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Shahid Beheshti 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>
        Lifestyle changes including diet therapy and weight loss can improve hypertriglyceridemia&#xD;
        (HTG) . Furthermore, increasing omega-3 fatty acids intake has therapeutic effects on HTG.&#xD;
        Alpha-linolenic acid is the precursor of long-chain omega-3 fatty acid and it is abundant in&#xD;
        sources such as chia seeds and flax seeds. Considering the high fiber and omega-3 content of&#xD;
        chia seeds and the existing mechanisms for improving lipid profile through fiber and omega-3,&#xD;
        animal studies have shown the positive role of chia seed consumption on lipid profile,&#xD;
        glycemic and lipid factors, and inflammation. However, in human studies, conflicting results&#xD;
        have been obtained and some studies have shown beneficial effects on blood lipid, glycemic,&#xD;
        and inflammatory factors, but in some studies, no effect has been observed. The objective of&#xD;
        this study is to determine the effects of chia seed consumption on lipids, glycemic and&#xD;
        inflammatory factors in people with HTG.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is an unblinded randomized controlled clinical trial. The study will be conducted&#xD;
        on people with mild to moderate hypertriglyceridemia whose fasting blood triglyceride levels&#xD;
        were between 150-499 mg/dL in the previous two tests. Participants who meet the following&#xD;
        criteria will not be included in the study: Being treated with fibrate medications, end-stage&#xD;
        kidney disease, acquired immunodeficiency syndrome patients, cancer patients undergoing&#xD;
        chemotherapy or radiotherapy, patients with liver cirrhosis, being treated glucocorticoids,&#xD;
        continuous use of omega-3 supplements or in the past month, and pregnancy or lactation.&#xD;
  &#xD;
        Patients will be randomly assigned to one of three study groups. The duration of the study&#xD;
        will be 8 week. The groups are: the control group, which is given a placebo pearls containing&#xD;
        sunflower oil. the omega-3 oil group will be given omega-3 pearls, and the chia seed group&#xD;
        that will consume chia seeds. In addition, the participants of all three groups are subjected&#xD;
        to a low-calorie diet. At the beginning and end of the study, the measurements include body&#xD;
        weight, blood pressure, blood concentration of lipids, lipoproteins and inflammatory factors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">March 14, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 28, 2023</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>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Plasma concentration of triglycerides</measure>
      <time_frame>8 week</time_frame>
      <description>Fasting plasma concentration of C-reactive protein and IL-6</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Weight loss</measure>
      <time_frame>8 week</time_frame>
      <description>Body wight loss (kg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma concentration of insulin</measure>
      <time_frame>8 weeks</time_frame>
      <description>Fasting plasma concentration of insulin</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma inflammatory factors concentration</measure>
      <time_frame>8 week</time_frame>
      <description>Fasting plasma concentration of C-reactive protein and IL-6</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Hypertriglyceridemia</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Reduced calorie diet along with placebo (sunflower oil) pearls</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Omega-3 supplementation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Reduced calorie diet along with omega-3 supplementation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Chia seed</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Reduced calorie diet along with chia seed consumption</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control</intervention_name>
      <description>Low-calorie diet with the use of placebo pearls (containing sunflower oil)</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Omega-3 supplementation</intervention_name>
      <description>Low-calorie diet with the use of marine omega-3 pearls (containing 1200 mg eicosapentaenoic acid + 600 mg docosahexaenoic acid/day)</description>
      <arm_group_label>Omega-3 supplementation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Chia seed</intervention_name>
      <description>Low-calorie diet with the consumption of 30 grams of powdered chia seeds</description>
      <arm_group_label>Chia seed</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  - Individuals who had fasting triglyceride concentration 150-499 mg/dL in their two&#xD;
               previous tests&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Being treated with fibrate medications&#xD;
  &#xD;
            -  Being treated glucocorticoids&#xD;
  &#xD;
            -  Being treated with anticoagulants (except aspirin)&#xD;
  &#xD;
            -  Continuous use of omega-3 supplements or in the past month&#xD;
  &#xD;
            -  End-stage kidney disease&#xD;
  &#xD;
            -  Acquired immunodeficiency syndrome patients&#xD;
  &#xD;
            -  Cancer patients undergoing chemotherapy or radiotherapy&#xD;
  &#xD;
            -  Patients with liver cirrhosis&#xD;
  &#xD;
            -  Pregnancy or lactation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mohammad R Shahparvari</last_name>
      <phone>+989126024463</phone>
      <email>shahparvarim@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute</name>
        <address>
          <city>Tehran</city>
          <zip>19395-4741</zip>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Iran, Islamic Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shahid Beheshti University of Medical Sciences</investigator_affiliation>
      <investigator_full_name>Javad Nasrollahzadeh</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertriglyceridemia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020950
  org study id: 43005340
  nct id: NCT06020950
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Lifestyle changes including diet therapy and weight loss can improve hypertriglyceridemia
        (HTG) . Furthermore, increasing omega-3 fatty acids intake has therapeutic effects on HTG.
        Alpha-linolenic acid is the precursor of long-chain omega-3 fatty acid and it is abundant in
        sources such as chia seeds and flax seeds. Considering the high fiber and omega-3 content of
        chia seeds and the existing mechanisms for improving lipid profile through fiber and omega-3,
        animal studies have shown the positive role of chia seed consumption on lipid profile,
        glycemic and lipid factors, and inflammation. However, in human studies, conflicting results
        have been obtained and some studies have shown beneficial effects on blood lipid, glycemic,
        and inflammatory factors, but in some studies, no effect has been observed. The objective of
        this study is to determine the effects of chia seed consumption on lipids, glycemic and
        inflammatory factors in people with HTG.
  This study is an unblinded randomized controlled clinical trial. The study will be conducted
        on people with mild to moderate hypertriglyceridemia whose fasting blood triglyceride levels
        were between 150-499 mg/dL in the previous two tests. Participants who meet the following
        criteria will not be included in the study: Being treated with fibrate medications, end-stage
        kidney disease, acquired immunodeficiency syndrome patients, cancer patients undergoing
        chemotherapy or radiotherapy, patients with liver cirrhosis, being treated glucocorticoids,
        continuous use of omega-3 supplements or in the past month, and pregnancy or lactation.
  
        Patients will be randomly assigned to one of three study groups. The duration of the study
        will be 8 week. The groups are: the control group, which is given a placebo pearls containing
        sunflower oil. the omega-3 oil group will be given omega-3 pearls, and the chia seed group
        that will consume chia seeds. In addition, the participants of all three groups are subjected
        to a low-calorie diet. At the beginning and end of the study, the measurements include body
        weight, blood pressure, blood concentration of lipids, lipoproteins and inflammatory factors.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Plasma concentration of triglycerides
  time frame: 8 week
  description: Fasting plasma concentration of C-reactive protein and IL-6
  measure: Weight loss
  time frame: 8 week
  description: Body wight loss (kg)
  measure: Plasma concentration of insulin
  time frame: 8 weeks
  description: Fasting plasma concentration of insulin
  measure: Plasma inflammatory factors concentration
  time frame: 8 week
  description: Fasting plasma concentration of C-reactive protein and IL-6
  arm group label: Control
  arm group type: Placebo Comparator
  description: Reduced calorie diet along with placebo (sunflower oil) pearls
  arm group label: Omega-3 supplementation
  arm group type: Active Comparator
  description: Reduced calorie diet along with omega-3 supplementation
  arm group label: Chia seed
  arm group type: Experimental
  description: Reduced calorie diet along with chia seed consumption
  intervention type: Other
  intervention name: Control
  description: Low-calorie diet with the use of placebo pearls (containing sunflower oil)
  arm group label: Control
  intervention type: Dietary Supplement
  intervention name: Omega-3 supplementation
  description: Low-calorie diet with the use of marine omega-3 pearls (containing 1200 mg eicosapentaenoic acid + 600 mg docosahexaenoic acid/day)
  arm group label: Omega-3 supplementation
  intervention type: Other
  intervention name: Chia seed
  description: Low-calorie diet with the consumption of 30 grams of powdered chia seeds
  arm group label: Chia seed
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Mohammad R Shahparvari
  phone: +989126024463
  email: shahparvarim@gmail.com
  facility: 
  country: Iran, Islamic Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Shahid Beheshti University of Medical Sciences
  investigator full name: Javad Nasrollahzadeh
  investigator title: Associate Professor
  mesh term: Hypertriglyceridemia
  sharing ipd: Undecided