<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/NCT03765580</url>
  </required_header>
  <id_info>
    <org_study_id>REC/16/0077</org_study_id>
    <nct_id>NCT03765580</nct_id>
  </id_info>
  <brief_title>The Influence of Fish Consumption on Polyunsaturated Fatty Acid (PUFA) Status</brief_title>
  <acronym>iFish</acronym>
  <official_title>The Influence of Fish Consumption on Polyunsaturated Fatty Acid (PUFA) Status (iFish Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Ulster</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, Republic of Seychelles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Ulster</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>
      Polyunsaturated fatty acids (PUFA) are important for health, for example for the immune&#xD;
      system, heart health and the brain. PUFA are found in fish, nuts and oils; including these&#xD;
      foods in the diet provides the body with PUFA. The body can also produce some PUFA in a&#xD;
      series of steps. It has been found that genetics influences the levels of PUFA produced in&#xD;
      the body. This study will investigate whether fish consumption influences PUFA status in&#xD;
      women of childbearing age when accounting for FADS genotype by conducting a controlled human&#xD;
      intervention study. Participants will be asked to consume none, one or two portions of oily&#xD;
      fish per week for 8 weeks and their response in PUFA status measured. This study will also&#xD;
      use collected blood, hair, urine and faecal samples collected from the intervention study to&#xD;
      explore other biomarkers of fish consumption. The aim of this study is to investigate whether&#xD;
      fish consumption influences PUFA status in women of childbearing age when accounting for FADS&#xD;
      genotype and to explore the potential of a novel biomarker, using hair MeHg:δ34S values, to&#xD;
      accurately predict fish consumption. The study will initially involve providing a buccal swab&#xD;
      sample which will investigate genes which are related to fatty acids. The participant will&#xD;
      provide a buccal swab sample so that their genotype can be determined. The researcher who&#xD;
      will contact the participant once genotype has been determined to arrange a baseline&#xD;
      appointment. Participants will attend the Human Intervention Studies Unit at Ulster&#xD;
      University, Coleraine once or twice weekly for a period of 8 weeks where they will receive&#xD;
      lunch. This lunch will contain either tuna, sardines, or no fish depending on the&#xD;
      intervention group you will be allocated to. Examples of lunch time meals they may receive&#xD;
      include sandwiches, baked potato or salad which will include the type of fish they have been&#xD;
      allocated to receive. Those allocated to the no fish group will receive a fish free&#xD;
      alternative lunch. Participants will be asked to continue to follow their normal diet and&#xD;
      lifestyle over the intervention period of 8 weeks. All participants will attend a baseline&#xD;
      and post intervention appointment where they will have weight, height and body composition&#xD;
      measured. Participants will also complete questionnaires to provide medical, lifestyle and&#xD;
      dietary information. All participants will be asked to provide a sample of blood, urine, hair&#xD;
      and faeces to assess biomarkers of fish consumption at baseline and post intervention&#xD;
      appointments. Collected blood, urine, hair and faecal samples will be analysed for biomarkers&#xD;
      of fish consumption. Participants will also be asked to return to the Human Intervention&#xD;
      Studies Unit (HISU) 8 weeks after the intervention study has been completed (week 16) to&#xD;
      provide a third hair sample and complete a Fish Feedback Questionnaire. In the 8 wks&#xD;
      following conclusion of the study they will be free to return to their normal diet.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Polyunsaturated fatty acid (PUFA) status</measure>
    <time_frame>Change at 8 weeks from baseline</time_frame>
    <description>Serum Polyunsaturated fatty acid (PUFA) status</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hair mercury</measure>
    <time_frame>Change at 8 &amp; 16 weeks from baseline</time_frame>
    <description>Hair mercury status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid profile</measure>
    <time_frame>Change at 8 weeks from baseline</time_frame>
    <description>Serum lipid profile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iodine</measure>
    <time_frame>Change at 8 weeks from baseline</time_frame>
    <description>Urine iodine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory status</measure>
    <time_frame>Change at 8 weeks from baseline</time_frame>
    <description>Cytokine concentration (Interleukin (IL)-5, IL-1β, IL-2, IL-4, IL-6, IL-10, MCP-1, TARC, sFlt-1, VEgF-D, CRP, TNF-α, IFN-γ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative stress</measure>
    <time_frame>Change at 8 weeks from baseline</time_frame>
    <description>Change in glutathione peroxidase and 8-isoprostanes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiota</measure>
    <time_frame>Change at 8 weeks from baseline</time_frame>
    <description>Faecal microbiota profile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thyroid hormones</measure>
    <time_frame>Change at 8 weeks from baseline</time_frame>
    <description>Serum T3, T4 and thyroid-stimulating hormone (TSH). Dried blood spot for thyroglobulin, T4 and TSH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stable isotopes</measure>
    <time_frame>Change at 8 &amp; 16 weeks from baseline</time_frame>
    <description>Hair methyl-mercury and sulphur-34</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Methyl-mercury (MeHg)</measure>
    <time_frame>Change at 8 weeks from baseline</time_frame>
    <description>Whole blood and urine MeHg</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Polyunsaturated Fatty Acid (PUFA) Status</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>No fish</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1 portion of fish per week</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>140g fish/week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 portions of fish per week</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>280g fish/week</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fish</intervention_name>
    <description>Lunch containing fish</description>
    <arm_group_label>1 portion of fish per week</arm_group_label>
    <arm_group_label>2 portions of fish per week</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Lunch containing no fish</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy females - premenopausal, child-bearing age, not planning to become pregnant&#xD;
&#xD;
          -  Age 18-45years old&#xD;
&#xD;
          -  Low consumers of fish (&lt;2 portions/ week) or those willing to reduce their fish&#xD;
             consumption one month prior to commencing the study to the equivalent of 2 portions&#xD;
             per month or less&#xD;
&#xD;
          -  Willing to eat 1 or 2 portions (140 grams or 280 grams) of either tuna or sardines per&#xD;
             week for a period of 8 weeks&#xD;
&#xD;
          -  Not consuming fish oil supplements&#xD;
&#xD;
          -  Not consuming protein supplements&#xD;
&#xD;
          -  Not allergic to seafood&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Regularly eat fish or not willing to do washout period where they reduce fish&#xD;
             consumption&#xD;
&#xD;
          -  Are allergic to seafood&#xD;
&#xD;
          -  Are taking fish oil supplements or are taking protein supplements&#xD;
&#xD;
          -  Are pregnant or menopausal&#xD;
&#xD;
          -  Have very short hair (a small section of hair, approximately 200 strands, will be&#xD;
             taken at the nap of the neck for analysis purposes)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Human Intervention Studies Unit, Ulster University</name>
      <address>
        <city>Coleraine</city>
        <state>Co.Londonderry</state>
        <zip>BT52 1SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Polyunsaturated fatty acids (PUFA)</keyword>
  <keyword>fish</keyword>
  <keyword>fish consumption</keyword>
  <keyword>women</keyword>
  <keyword>childbearing age</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03765580
org study id: REC/16/0077
nct id: NCT03765580
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Polyunsaturated fatty acids (PUFA) are important for health, for example for the immune
      system, heart health and the brain. PUFA are found in fish, nuts and oils; including these
      foods in the diet provides the body with PUFA. The body can also produce some PUFA in a
      series of steps. It has been found that genetics influences the levels of PUFA produced in
      the body. This study will investigate whether fish consumption influences PUFA status in
      women of childbearing age when accounting for FADS genotype by conducting a controlled human
      intervention study. Participants will be asked to consume none, one or two portions of oily
      fish per week for 8 weeks and their response in PUFA status measured. This study will also
      use collected blood, hair, urine and faecal samples collected from the intervention study to
      explore other biomarkers of fish consumption. The aim of this study is to investigate whether
      fish consumption influences PUFA status in women of childbearing age when accounting for FADS
      genotype and to explore the potential of a novel biomarker, using hair MeHg:δ34S values, to
      accurately predict fish consumption. The study will initially involve providing a buccal swab
      sample which will investigate genes which are related to fatty acids. The participant will
      provide a buccal swab sample so that their genotype can be determined. The researcher who
      will contact the participant once genotype has been determined to arrange a baseline
      appointment. Participants will attend the Human Intervention Studies Unit at Ulster
      University, Coleraine once or twice weekly for a period of 8 weeks where they will receive
      lunch. This lunch will contain either tuna, sardines, or no fish depending on the
      intervention group you will be allocated to. Examples of lunch time meals they may receive
      include sandwiches, baked potato or salad which will include the type of fish they have been
      allocated to receive. Those allocated to the no fish group will receive a fish free
      alternative lunch. Participants will be asked to continue to follow their normal diet and
      lifestyle over the intervention period of 8 weeks. All participants will attend a baseline
      and post intervention appointment where they will have weight, height and body composition
      measured. Participants will also complete questionnaires to provide medical, lifestyle and
      dietary information. All participants will be asked to provide a sample of blood, urine, hair
      and faeces to assess biomarkers of fish consumption at baseline and post intervention
      appointments. Collected blood, urine, hair and faecal samples will be analysed for biomarkers
      of fish consumption. Participants will also be asked to return to the Human Intervention
      Studies Unit (HISU) 8 weeks after the intervention study has been completed (week 16) to
      provide a third hair sample and complete a Fish Feedback Questionnaire. In the 8 wks
      following conclusion of the study they will be free to return to their normal diet.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Polyunsaturated fatty acid (PUFA) status
time frame: Change at 8 weeks from baseline
description: Serum Polyunsaturated fatty acid (PUFA) status
measure: Hair mercury
time frame: Change at 8 & 16 weeks from baseline
description: Hair mercury status
measure: Lipid profile
time frame: Change at 8 weeks from baseline
description: Serum lipid profile
measure: Iodine
time frame: Change at 8 weeks from baseline
description: Urine iodine
measure: Inflammatory status
time frame: Change at 8 weeks from baseline
description: Cytokine concentration (Interleukin (IL)-5, IL-1β, IL-2, IL-4, IL-6, IL-10, MCP-1, TARC, sFlt-1, VEgF-D, CRP, TNF-α, IFN-γ)
measure: Oxidative stress
time frame: Change at 8 weeks from baseline
description: Change in glutathione peroxidase and 8-isoprostanes
measure: Microbiota
time frame: Change at 8 weeks from baseline
description: Faecal microbiota profile
measure: Thyroid hormones
time frame: Change at 8 weeks from baseline
description: Serum T3, T4 and thyroid-stimulating hormone (TSH). Dried blood spot for thyroglobulin, T4 and TSH
measure: Stable isotopes
time frame: Change at 8 & 16 weeks from baseline
description: Hair methyl-mercury and sulphur-34
measure: Methyl-mercury (MeHg)
time frame: Change at 8 weeks from baseline
description: Whole blood and urine MeHg
arm group label: Control group
arm group type: Placebo Comparator
description: No fish
arm group label: 1 portion of fish per week
arm group type: Experimental
description: 140g fish/week
arm group label: 2 portions of fish per week
arm group type: Experimental
description: 280g fish/week
intervention type: Dietary Supplement
intervention name: Fish
description: Lunch containing fish
arm group label: 1 portion of fish per week
arm group label: 2 portions of fish per week
intervention type: Other
intervention name: Control
description: Lunch containing no fish
arm group label: Control group
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: Undecided