<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/NCT02982525</url>
  </required_header>
  <id_info>
    <org_study_id>2016/RINH/7</org_study_id>
    <nct_id>NCT02982525</nct_id>
  </id_info>
  <brief_title>Mussel Intake and Vitamin D Status in Humans</brief_title>
  <acronym>Mussel</acronym>
  <official_title>Effect of Mussel Intake on Vitamin D Status Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aberdeen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aberdeen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A significant proportion of the United Kingdom population have inadequate levels of vitamin D&#xD;
      in their blood. Vitamin D is a fat-soluble vitamin that is essential for the growth and&#xD;
      maintenance of healthy bones through increasing dietary calcium absorption within the body. A&#xD;
      low vitamin D status has also been associated with other diseases such as osteoporosis,&#xD;
      cancer (especially colorectal cancer), cardiovascular disease and type 1 diabetes. Our skin&#xD;
      is able to synthesise vitamin D upon exposure to sunlight in summer. If exposure to sunlight&#xD;
      is limited, then a dietary supply of vitamin D becomes essential.&#xD;
&#xD;
      However, very few foods contain vitamin D. Among the best dietary sources of vitamin D are&#xD;
      oily fish (including salmon, mackerel, herring and trout) and fish oils. Recently, the&#xD;
      investigators found that certain shellfish, especially mussels, contain significant amounts&#xD;
      of a metabolite of vitamin D, 25(OH)D3. Consumption of this metabolite, as a supplement, has&#xD;
      already been shown to improve vitamin D status in humans. Whether consumption of mussels&#xD;
      improves vitamin D status is unknown.&#xD;
&#xD;
      In this study the investigators will be looking at whether consumption of 1, 2 or 3 portions&#xD;
      of mussels per week for 12 weeks increases vitamin D status in healthy people.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vitamin D, the main forms being vitamin D2 (ergocalciferol) and D3 (cholecalciferol), is a&#xD;
      group of fat-soluble secosteroids which are synthesised from ergosterol in fungi and yeast,&#xD;
      or from 7-dehydrocholesterol in humans, animals including fish and plants including&#xD;
      microalgae, upon exposure to UV radiation. The metabolically inert vitamin D3 is then&#xD;
      converted into 25-hydroxy D3 (25(OH)D3) and subsequently into 1α,25-dihydroxy D3&#xD;
      (1,25(OH)2D3).&#xD;
&#xD;
      A significant proportion of the global population have inadequate vitamin D levels - as&#xD;
      defined by a plasma 25(OH)D concentration of &lt;25 nM, - a level where the risk of poor&#xD;
      musculoskeletal health appears to increase, which is especially apparent in older children,&#xD;
      younger adults, older institutionalised individuals and infants from black and ethnic&#xD;
      minority groups. Data from the NDNS and other studies suggest that between 29 and 54% of&#xD;
      various population groups in the UK have a serum 25(OH)D concentration &lt; 25 nmol/L in the&#xD;
      winter. However, summer synthesis of vitamin D, facilitating maintenance of winter serum&#xD;
      25(OH)D concentration ≥ 25 nmol/L is clearly not occurring for many in the UK population&#xD;
      (Consultation on draft SACN Vitamin D and Health report). If there is inadequate vitamin D3&#xD;
      synthesis within the skin, generally caused by limited exposure to sunlight, then a dietary&#xD;
      supply of vitamin D becomes essential.&#xD;
&#xD;
      Overall however, very few foods contain vitamin D. Among the best dietary sources of vitamin&#xD;
      D are oily fish (including salmon, mackerel, herring and trout) and fish oils, providing up&#xD;
      to 20g of vitamin D per 100 g. Lower amounts of vitamin D are present in red meat, liver and&#xD;
      egg yolks (approximately 1-5g/100 g). Vitamin D in these foods and in fish is primarily in&#xD;
      the form of vitamin D3 and its metabolite 25(OH)D3.&#xD;
&#xD;
      Recently, investigators have found that certain shellfish, especially mussels, contain&#xD;
      significant amounts of 25(OH)D3, ranging from 0.7 to 9.9 µg/100 g wet weight. Thus far, food&#xD;
      composition databases give either very low or no values for levels of vitamin D in shellfish.&#xD;
      The amount of vitamin D3 in mussels is either reported to be below the detection limit, or is&#xD;
      not analysed, in mussels in the food database analysis. The importance of finding 25(OH)D3&#xD;
      rather than vitamin D3 in mussels is illustrated by the fact that this metabolite is&#xD;
      considered 5 times more effective in raising serum 25(OH)D3 levels in humans, and thus&#xD;
      vitamin D status, than vitamin D3 itself. An interesting parallel with meat appears. Meat&#xD;
      contains little native vitamin D but as better measurement techniques detected more&#xD;
      metabolites of vitamin D, which were considered to be more potent, these have been added to&#xD;
      food composition tables. Indeed, the apparent increase in vitamin D intakes in the British&#xD;
      household food data, in 1995 and 1996, is a direct result of including the potency factor for&#xD;
      meat. Taking account of this potency factor, mussels could provide up to 50g of vitamin D per&#xD;
      100g. Whether consumption of mussels improves vitamin D status in humans is however, not&#xD;
      known.&#xD;
&#xD;
      According to exploratory meta-regression analyses of RCT data in a number of European&#xD;
      (51-60°N) winter-based, dose-related RCTs which used supplemental doses of vitamin D between&#xD;
      0-20 μg/d, have reported vitamin D-serum 25(OH)D concentration slope estimates of 1.55-2.43&#xD;
      nmol/L increment per 1 μg vitamin D (Consultation on draft SACN Vitamin D and Health report).&#xD;
      Thus 1, 2 and 3 portions of mussels per week, providing the equivalent of approx. 2.7, 5.4&#xD;
      and 8.0 mg/day (including the potency factor of 5) may increase serum levels of 25(OH)D3 by&#xD;
      4.2-6.6 nmol/L for 1 portion of mussels per week, 8.4-13.1 nmol/L for 2 portions per week or&#xD;
      12.4-19.4 nmol/L for 3 portions of mussels per week&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">April 20, 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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Vitamin D status</measure>
    <time_frame>At baseline and after 12 weeks mussel supplementation</time_frame>
    <description>Serum Vitamin D status will be assessed by measuring plasma 25-hydroxy vitamin D3 by Liquid Chromatography/Mass Spectrometry, the gold standard method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vitamin B12 status</measure>
    <time_frame>At baseline and after 12 weeks mussel supplementation</time_frame>
    <description>Vitamin B12 status will be measured in plasma using the microbiological assay using L. Delbrueckii. Lactis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in omega-3 index</measure>
    <time_frame>At baseline and after 12 weeks mussel supplementation</time_frame>
    <description>The Omega-3 index will be measured by Gas Chromatography-Mass Spectrometry. An optimal target level of the Omega-3 index is 8%, and an undesirable level is less than 4%, with 4-8% being an intermediate-risk zone.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>No Mussels</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The control group will continue to consume their normal habitual diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>One mussel portion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One 75g portion of Scottish mussels provided per week for 12 weeks on top of normal habitual shellfish consumption.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Two mussel portions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two 75g portions of Scottish mussels provided per week for 12 weeks on top of normal habitual shellfish consumption</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Three mussel portions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three 75g portion of Scottish mussels provided per week for 12 weeks on top of normal habitual shellfish consumption</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>No Mussels</intervention_name>
    <description>Habitual diet only</description>
    <arm_group_label>No Mussels</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>One mussel portion</intervention_name>
    <description>1 x 75g mussel portions provided per week</description>
    <arm_group_label>One mussel portion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Two mussel portions</intervention_name>
    <description>2 x 75g mussel portions provided per week</description>
    <arm_group_label>Two mussel portions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Three mussel portions</intervention_name>
    <description>3 x 75g mussel portions provided per week</description>
    <arm_group_label>Three mussel portions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI ranging from 18-35&#xD;
&#xD;
          -  Not having any food allergies&#xD;
&#xD;
          -  Not taking any fish oil or certain nutritional / vitamin supplements&#xD;
&#xD;
          -  Non-smoker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Regularly take aspirin or aspirin-containing drugs&#xD;
&#xD;
          -  Taking drugs or herbal medicines known to alter the haemostatic system in general&#xD;
&#xD;
          -  Taking certain dietary supplements / multivitamin tablets&#xD;
&#xD;
          -  Anyone suffering from diabetes, hypertension, renal, hepatic or haematological disease&#xD;
&#xD;
          -  Heart / circulation problems&#xD;
&#xD;
          -  Eating disorders&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Any existing shellfish allergy&#xD;
&#xD;
          -  Having difficult venous access or problems giving blood in the past&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Baukje De Roos, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aberdeen, The Rowett Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Aberdeen, The Rowett Institute</name>
      <address>
        <city>Aberdeen</city>
        <zip>AB25 2ZD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>October 8, 2019</last_update_submitted>
  <last_update_submitted_qc>October 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mussels</keyword>
  <keyword>Dietary Intervention</keyword>
  <keyword>Long-term intervention</keyword>
  <keyword>Vitamin D status</keyword>
  <keyword>Selenium</keyword>
  <keyword>Iodine</keyword>
  <keyword>Vitamin B12</keyword>
  <keyword>Omega-3 index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT02982525
org study id: 2016/RINH/7
nct id: NCT02982525
lead sponsor: 
has dmc: No
A significant proportion of the United Kingdom population have inadequate levels of vitamin D
      in their blood. Vitamin D is a fat-soluble vitamin that is essential for the growth and
      maintenance of healthy bones through increasing dietary calcium absorption within the body. A
      low vitamin D status has also been associated with other diseases such as osteoporosis,
      cancer (especially colorectal cancer), cardiovascular disease and type 1 diabetes. Our skin
      is able to synthesise vitamin D upon exposure to sunlight in summer. If exposure to sunlight
      is limited, then a dietary supply of vitamin D becomes essential.

      However, very few foods contain vitamin D. Among the best dietary sources of vitamin D are
      oily fish (including salmon, mackerel, herring and trout) and fish oils. Recently, the
      investigators found that certain shellfish, especially mussels, contain significant amounts
      of a metabolite of vitamin D, 25(OH)D3. Consumption of this metabolite, as a supplement, has
      already been shown to improve vitamin D status in humans. Whether consumption of mussels
      improves vitamin D status is unknown.

      In this study the investigators will be looking at whether consumption of 1, 2 or 3 portions
      of mussels per week for 12 weeks increases vitamin D status in healthy people.
Vitamin D, the main forms being vitamin D2 (ergocalciferol) and D3 (cholecalciferol), is a
      group of fat-soluble secosteroids which are synthesised from ergosterol in fungi and yeast,
      or from 7-dehydrocholesterol in humans, animals including fish and plants including
      microalgae, upon exposure to UV radiation. The metabolically inert vitamin D3 is then
      converted into 25-hydroxy D3 (25(OH)D3) and subsequently into 1α,25-dihydroxy D3
      (1,25(OH)2D3).

      A significant proportion of the global population have inadequate vitamin D levels - as
      defined by a plasma 25(OH)D concentration of <25 nM, - a level where the risk of poor
      musculoskeletal health appears to increase, which is especially apparent in older children,
      younger adults, older institutionalised individuals and infants from black and ethnic
      minority groups. Data from the NDNS and other studies suggest that between 29 and 54% of
      various population groups in the UK have a serum 25(OH)D concentration < 25 nmol/L in the
      winter. However, summer synthesis of vitamin D, facilitating maintenance of winter serum
      25(OH)D concentration ≥ 25 nmol/L is clearly not occurring for many in the UK population
      (Consultation on draft SACN Vitamin D and Health report). If there is inadequate vitamin D3
      synthesis within the skin, generally caused by limited exposure to sunlight, then a dietary
      supply of vitamin D becomes essential.

      Overall however, very few foods contain vitamin D. Among the best dietary sources of vitamin
      D are oily fish (including salmon, mackerel, herring and trout) and fish oils, providing up
      to 20g of vitamin D per 100 g. Lower amounts of vitamin D are present in red meat, liver and
      egg yolks (approximately 1-5g/100 g). Vitamin D in these foods and in fish is primarily in
      the form of vitamin D3 and its metabolite 25(OH)D3.

      Recently, investigators have found that certain shellfish, especially mussels, contain
      significant amounts of 25(OH)D3, ranging from 0.7 to 9.9 µg/100 g wet weight. Thus far, food
      composition databases give either very low or no values for levels of vitamin D in shellfish.
      The amount of vitamin D3 in mussels is either reported to be below the detection limit, or is
      not analysed, in mussels in the food database analysis. The importance of finding 25(OH)D3
      rather than vitamin D3 in mussels is illustrated by the fact that this metabolite is
      considered 5 times more effective in raising serum 25(OH)D3 levels in humans, and thus
      vitamin D status, than vitamin D3 itself. An interesting parallel with meat appears. Meat
      contains little native vitamin D but as better measurement techniques detected more
      metabolites of vitamin D, which were considered to be more potent, these have been added to
      food composition tables. Indeed, the apparent increase in vitamin D intakes in the British
      household food data, in 1995 and 1996, is a direct result of including the potency factor for
      meat. Taking account of this potency factor, mussels could provide up to 50g of vitamin D per
      100g. Whether consumption of mussels improves vitamin D status in humans is however, not
      known.

      According to exploratory meta-regression analyses of RCT data in a number of European
      (51-60°N) winter-based, dose-related RCTs which used supplemental doses of vitamin D between
      0-20 μg/d, have reported vitamin D-serum 25(OH)D concentration slope estimates of 1.55-2.43
      nmol/L increment per 1 μg vitamin D (Consultation on draft SACN Vitamin D and Health report).
      Thus 1, 2 and 3 portions of mussels per week, providing the equivalent of approx. 2.7, 5.4
      and 8.0 mg/day (including the potency factor of 5) may increase serum levels of 25(OH)D3 by
      4.2-6.6 nmol/L for 1 portion of mussels per week, 8.4-13.1 nmol/L for 2 portions per week or
      12.4-19.4 nmol/L for 3 portions of mussels per week
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Change in Vitamin D status
time frame: At baseline and after 12 weeks mussel supplementation
description: Serum Vitamin D status will be assessed by measuring plasma 25-hydroxy vitamin D3 by Liquid Chromatography/Mass Spectrometry, the gold standard method
measure: Vitamin B12 status
time frame: At baseline and after 12 weeks mussel supplementation
description: Vitamin B12 status will be measured in plasma using the microbiological assay using L. Delbrueckii. Lactis
measure: Change in omega-3 index
time frame: At baseline and after 12 weeks mussel supplementation
description: The Omega-3 index will be measured by Gas Chromatography-Mass Spectrometry. An optimal target level of the Omega-3 index is 8%, and an undesirable level is less than 4%, with 4-8% being an intermediate-risk zone.
arm group label: No Mussels
arm group type: Experimental
description: The control group will continue to consume their normal habitual diet
arm group label: One mussel portion
arm group type: Experimental
description: One 75g portion of Scottish mussels provided per week for 12 weeks on top of normal habitual shellfish consumption.
arm group label: Two mussel portions
arm group type: Experimental
description: Two 75g portions of Scottish mussels provided per week for 12 weeks on top of normal habitual shellfish consumption
arm group label: Three mussel portions
arm group type: Experimental
description: Three 75g portion of Scottish mussels provided per week for 12 weeks on top of normal habitual shellfish consumption
intervention type: Dietary Supplement
intervention name: No Mussels
description: Habitual diet only
arm group label: No Mussels
intervention type: Dietary Supplement
intervention name: One mussel portion
description: 1 x 75g mussel portions provided per week
arm group label: One mussel portion
intervention type: Dietary Supplement
intervention name: Two mussel portions
description: 2 x 75g mussel portions provided per week
arm group label: Two mussel portions
intervention type: Dietary Supplement
intervention name: Three mussel portions
description: 3 x 75g mussel portions provided per week
arm group label: Three mussel portions
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Baukje De Roos, PhD
role: Principal Investigator
affiliation: University of Aberdeen, The Rowett Institute
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: No