<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/NCT04418102</url>
  </required_header>
  <id_info>
    <org_study_id>HR-19/20-14655</org_study_id>
    <nct_id>NCT04418102</nct_id>
  </id_info>
  <brief_title>The InterSat Study</brief_title>
  <acronym>InterSat</acronym>
  <official_title>The InterSat Study: Interesterified Fats: Health Effects of Commercially Relevant Palmitic Versus Stearic Acid Rich Interesterified Fats</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maastricht University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College London</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>
      In response to the removal of trans fats from our foods, the food industry now uses&#xD;
      interesterified (IE) fats. Randomly interesterified (IE) fats rich in palmitic (Europe) and&#xD;
      stearic (North America) acids are the most commonly used IE fats by the food industry.&#xD;
      Despite their widespread use, there has been no published research on the acute and chronic&#xD;
      cardio-metabolic health effects of the most commonly consumed palmitic and stearic acid rich&#xD;
      IE fats. The aim of InterSat is to investigate the postprandial and chronic effects of a diet&#xD;
      rich in IE fats on cardiometabolic health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Choice of design: A randomised crossover study with two arms, each arm consisting of a 6-week&#xD;
      dietary intervention, separated by a 3-week (minimum) washout period.&#xD;
&#xD;
      Study population: Healthy adult snackers aged 35-65 years. 48 participants in total, 24 at&#xD;
      each centre (see Locations).&#xD;
&#xD;
      Locations:&#xD;
&#xD;
      Metabolic Research Unit, Franklin-Wilkins Building, Waterloo Campus, King College London.&#xD;
&#xD;
      Metabolic Research Unit Maastricht, Academic Hospital Maastricht, Maastricht University.&#xD;
&#xD;
      Screening Assessment: Prospective participants will be selected based on the defined&#xD;
      inclusion and exclusion criteria by the study management team. Recruitment will be done over&#xD;
      the phone and via the Internet and emails and prospective participants will be booked in for&#xD;
      their initial appointment to acquire baseline measurements.&#xD;
&#xD;
      Study duration: A 2-week run-in period, two 6-week dietary interventions, and a 3-week&#xD;
      (minimum) washout period.&#xD;
&#xD;
      Dietary intervention: The InterSat intervention aims to provide 10% of total daily energy&#xD;
      intake in the form of IE fat. These will be consumed in the form of muffins and spreads,&#xD;
      designed to replace typically consumed snacks and spreads throughout the day. Energy&#xD;
      requirements will be calculated using the Henry equation and physical activity levels (PAL).&#xD;
&#xD;
      At the baseline visit, participants will have and anthropometric measures and fasted blood&#xD;
      samples taken, and will be assessed for endothelial function via flow mediated dilation&#xD;
      (FMD), after which they will be provided with enough muffins and spread for a 2-week period,&#xD;
      as well a study booklet (containing instructions and a diary to log muffin and spread&#xD;
      consumption). They will receive guidance on how to incorporate the muffins and spread into&#xD;
      their diet. Food collection dates will be set, and participants are then free to leave. At&#xD;
      the second visit (first snack collection visit), no physical measures are taken, but the&#xD;
      empty tubs and muffin cases are collected, and the study booklet is checked by a researcher&#xD;
      to ensure the participant is compliant to the intervention. Any issues should be discussed,&#xD;
      and guidance given to increase compliance if necessary. Another snack collection visit is&#xD;
      booked. At the end of the 6-week intervention, participants will undergo physical and blood&#xD;
      sampling as well as FMD, as with the baseline testing day. After a 3-week (minimum) washout&#xD;
      period, the same procedures occur for the other arm of the trial.&#xD;
&#xD;
      Anthropometry: Weight, height, waist and hip circumference, blood pressure, body fat will be&#xD;
      taken using standard procedures, in duplicates by a trained researcher at all face to face&#xD;
      appointments.&#xD;
&#xD;
      Habitual food intake: Participants will complete the EPIC (European prospective investigation&#xD;
      of cancer) food frequency questionnaire at the screening visit. They will also complete three&#xD;
      4-day diet diaries (one at the run-in period and one in each of the dietary intervention&#xD;
      periods).&#xD;
&#xD;
      Blood samples: Fasting blood samples will be collected from a superficial antecubital vein&#xD;
      via venepuncture before and after each dietary intervention. Postprandial blood samples will&#xD;
      be taken via cannulation in a subgroup (see Subgroup below) for an 8-hour postprandial test&#xD;
      day.&#xD;
&#xD;
      Participants will be asked to record and monitor the following information:&#xD;
&#xD;
      Amount of muffins and spread consumed (study booklet). Habitual intake (4-day diet diaries).&#xD;
&#xD;
      Subgroup: A subset (n = 24) of participants will undergo a postprandial test day at the&#xD;
      baseline and 6-week points of each intervention arm. After baseline samples (anthropometrics,&#xD;
      blood samples, FMD) are taken, participants will consume a breakfast containing a large bolus&#xD;
      of the IE fat they are assigned to. Blood samples will be taken over an 8-hour testing period&#xD;
      and FMD will be taken 2 more times. Liver fat will be assessed via MRI imaging (Maastricht&#xD;
      only).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Actual">August 25, 2022</completion_date>
  <primary_completion_date type="Actual">August 25, 2022</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomised controlled trial with 2x6 week interventions separated by a 3 week washout.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in fasting total:HDL cholesterol ratio</measure>
    <time_frame>6 weeks</time_frame>
    <description>Total to high-density lipoprotein (Total:HDL) cholesterol ratio</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postprandial lipaemia</measure>
    <time_frame>Fasting, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.</time_frame>
    <description>Plasma triglyceride concentrations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial function</measure>
    <time_frame>Fasting, 270 min and 450 min following consumption of breakfast containing IE fats</time_frame>
    <description>Flow mediated dilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial glucose homeostasis (Incremental area under the curve (iAUC) 0-240 min and 0-480 min)</measure>
    <time_frame>Fasting, 30 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.</time_frame>
    <description>Glucose, Insulin, C-peptide, Non-esterified fatty acids (NEFA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Insulin sensitivity</measure>
    <time_frame>Fasting, 30 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.</time_frame>
    <description>Revised Quantitative Insulin Sensitivity Check Index (RQUICKI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in liver fat (Maastricht only)</measure>
    <time_frame>6 weeks</time_frame>
    <description>MRI (magnetic resonance imaging)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting total cholesterol</measure>
    <time_frame>6 weeks</time_frame>
    <description>Fasting plasma total cholesterol concentrations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting LDL cholesterol</measure>
    <time_frame>6 weeks</time_frame>
    <description>Fasting plasma low density lipoprotein cholesterol (LDL-C) concentrations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting Lp(a)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Fasting plasma lipoprotein a (Lp(a))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting apoA1</measure>
    <time_frame>6 weeks</time_frame>
    <description>Fasting plasma apolipoprotein A1 (apoA1),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting apoB</measure>
    <time_frame>6 weeks</time_frame>
    <description>Fasting plasma apolipoprotein B (apo B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in plasma total fatty acid composition</measure>
    <time_frame>6 weeks</time_frame>
    <description>Fasting plasma total fatty acid composition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting glucose</measure>
    <time_frame>6 weeks</time_frame>
    <description>Fasting plasma glucose concentrations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting insulin</measure>
    <time_frame>6 weeks</time_frame>
    <description>Fasting plasma insulin concentrations</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Cardiometabolic Health</condition>
  <arm_group>
    <arm_group_label>Palmitic acid rich interesterified fat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Snacks (muffins) and spread containing palmitic acid rich interesterified fat to replace habitual snacks and spreads, and provide 10% of total daily energy intake with the interesterified fat.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stearic acid rich interesterified fat</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Snacks (muffins) and spread containing stearic acid rich interesterified fat to replace habitual snacks and spreads, and provide 10% of total daily energy intake with the interesterified fat.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Palmitic acid rich interesterified fat</intervention_name>
    <description>Muffins and spread containing the palmitic acid rich IE fat will be consumed daily for a 6-week dietary intervention period</description>
    <arm_group_label>Palmitic acid rich interesterified fat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Stearic acid rich interesterified fat</intervention_name>
    <description>Muffins and spread containing the palmitic acid rich IE fat will be consumed daily for a 6-week dietary intervention period.</description>
    <arm_group_label>Stearic acid rich interesterified fat</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy (free of diagnosed diseases listed in exclusion criteria).&#xD;
&#xD;
          -  Able to give informed consent.&#xD;
&#xD;
          -  Able to give informed consent.&#xD;
&#xD;
          -  Accessible veins on arms as determined by examination at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a medical condition or history which might impact study measurements, to be&#xD;
             judged by the study physician (e.g. myocardial infarction, angina, thrombosis, stroke,&#xD;
             cancer, liver or bowel disease or diabetes)&#xD;
&#xD;
          -  Use of plant-sterol/stanol-enriched foods or supplements in the three months prior to&#xD;
             the screening and/or during the study&#xD;
&#xD;
          -  Body mass index &lt; 20 kg/m2 or &gt; 35 kg/m2&#xD;
&#xD;
          -  Plasma cholesterol ≥7.5 mmol/L&#xD;
&#xD;
          -  Plasma triacylglycerol &gt; 3 mmol/L&#xD;
&#xD;
          -  Plasma glucose &gt; 7 mmol/L&#xD;
&#xD;
          -  Full blood count (FBC), liver function out of healthy range&#xD;
&#xD;
          -  Blood pressure ≥140/90 mmHg&#xD;
&#xD;
          -  Current use of antihypertensive or lipid lowering medications&#xD;
&#xD;
          -  Use of over-the-counter and prescribed medication, which may interfere with study&#xD;
             measurements (to be judged by the principal investigator)&#xD;
&#xD;
          -  Alcohol intake exceeding a moderate intake (&gt; 21 units per week)&#xD;
&#xD;
          -  Current cigarette smoker (or quit within last 6 months)&#xD;
&#xD;
          -  ≥ 20% 10-year risk of cardiovascular disease (CVD) as calculated using a risk&#xD;
             calculator&#xD;
&#xD;
          -  Active blood donor or plans to donate blood within 6 months of study completion&#xD;
&#xD;
          -  Use of oral antibiotics (with the exception of topical antibiotics) in 40 days or less&#xD;
             prior to the start of the study&#xD;
&#xD;
          -  Reported weight loss or gain of 3 kg or more during a period of 2 months prior to&#xD;
             screening&#xD;
&#xD;
          -  Reported dietary habits: medically prescribed diet, allergy/intolerance to test&#xD;
             products that will be provided during the study&#xD;
&#xD;
          -  Reported participation in another nutritional or biomedical trial 3 months prior to&#xD;
             screening&#xD;
&#xD;
          -  Reported participation in night shift work 2 weeks prior to screening and/or during&#xD;
             the study. Night work is defined as working between midnight and 6.00 am Anyone who&#xD;
             has given blood in the last 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Maastricht University</name>
      <address>
        <city>Maastricht</city>
        <zip>616 6200</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Nutritional Sciences, King's College London. Franklin-Wilkins Buiding. Waterloo Campus</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>SE1 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>February 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>April 18, 2023</last_update_submitted>
  <last_update_submitted_qc>April 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Interesterified fat</keyword>
  <keyword>Cardiometabolic health</keyword>
  <keyword>Palmitic acid</keyword>
  <keyword>Stearic acid</keyword>
  <keyword>Vascular function</keyword>
  <keyword>Postprandial lipaemia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Palmitic Acid</mesh_term>
  </intervention_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/NCT04418102
org study id: HR-19/20-14655
nct id: NCT04418102
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In response to the removal of trans fats from our foods, the food industry now uses
      interesterified (IE) fats. Randomly interesterified (IE) fats rich in palmitic (Europe) and
      stearic (North America) acids are the most commonly used IE fats by the food industry.
      Despite their widespread use, there has been no published research on the acute and chronic
      cardio-metabolic health effects of the most commonly consumed palmitic and stearic acid rich
      IE fats. The aim of InterSat is to investigate the postprandial and chronic effects of a diet
      rich in IE fats on cardiometabolic health.
Choice of design: A randomised crossover study with two arms, each arm consisting of a 6-week
      dietary intervention, separated by a 3-week (minimum) washout period.

      Study population: Healthy adult snackers aged 35-65 years. 48 participants in total, 24 at
      each centre (see Locations).

      Locations:

      Metabolic Research Unit, Franklin-Wilkins Building, Waterloo Campus, King College London.

      Metabolic Research Unit Maastricht, Academic Hospital Maastricht, Maastricht University.

      Screening Assessment: Prospective participants will be selected based on the defined
      inclusion and exclusion criteria by the study management team. Recruitment will be done over
      the phone and via the Internet and emails and prospective participants will be booked in for
      their initial appointment to acquire baseline measurements.

      Study duration: A 2-week run-in period, two 6-week dietary interventions, and a 3-week
      (minimum) washout period.

      Dietary intervention: The InterSat intervention aims to provide 10% of total daily energy
      intake in the form of IE fat. These will be consumed in the form of muffins and spreads,
      designed to replace typically consumed snacks and spreads throughout the day. Energy
      requirements will be calculated using the Henry equation and physical activity levels (PAL).

      At the baseline visit, participants will have and anthropometric measures and fasted blood
      samples taken, and will be assessed for endothelial function via flow mediated dilation
      (FMD), after which they will be provided with enough muffins and spread for a 2-week period,
      as well a study booklet (containing instructions and a diary to log muffin and spread
      consumption). They will receive guidance on how to incorporate the muffins and spread into
      their diet. Food collection dates will be set, and participants are then free to leave. At
      the second visit (first snack collection visit), no physical measures are taken, but the
      empty tubs and muffin cases are collected, and the study booklet is checked by a researcher
      to ensure the participant is compliant to the intervention. Any issues should be discussed,
      and guidance given to increase compliance if necessary. Another snack collection visit is
      booked. At the end of the 6-week intervention, participants will undergo physical and blood
      sampling as well as FMD, as with the baseline testing day. After a 3-week (minimum) washout
      period, the same procedures occur for the other arm of the trial.

      Anthropometry: Weight, height, waist and hip circumference, blood pressure, body fat will be
      taken using standard procedures, in duplicates by a trained researcher at all face to face
      appointments.

      Habitual food intake: Participants will complete the EPIC (European prospective investigation
      of cancer) food frequency questionnaire at the screening visit. They will also complete three
      4-day diet diaries (one at the run-in period and one in each of the dietary intervention
      periods).

      Blood samples: Fasting blood samples will be collected from a superficial antecubital vein
      via venepuncture before and after each dietary intervention. Postprandial blood samples will
      be taken via cannulation in a subgroup (see Subgroup below) for an 8-hour postprandial test
      day.

      Participants will be asked to record and monitor the following information:

      Amount of muffins and spread consumed (study booklet). Habitual intake (4-day diet diaries).

      Subgroup: A subset (n = 24) of participants will undergo a postprandial test day at the
      baseline and 6-week points of each intervention arm. After baseline samples (anthropometrics,
      blood samples, FMD) are taken, participants will consume a breakfast containing a large bolus
      of the IE fat they are assigned to. Blood samples will be taken over an 8-hour testing period
      and FMD will be taken 2 more times. Liver fat will be assessed via MRI imaging (Maastricht
      only).
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomised controlled trial with 2x6 week interventions separated by a 3 week washout.
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in fasting total:HDL cholesterol ratio
time frame: 6 weeks
description: Total to high-density lipoprotein (Total:HDL) cholesterol ratio
measure: Postprandial lipaemia
time frame: Fasting, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.
description: Plasma triglyceride concentrations
measure: Endothelial function
time frame: Fasting, 270 min and 450 min following consumption of breakfast containing IE fats
description: Flow mediated dilation
measure: Postprandial glucose homeostasis (Incremental area under the curve (iAUC) 0-240 min and 0-480 min)
time frame: Fasting, 30 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.
description: Glucose, Insulin, C-peptide, Non-esterified fatty acids (NEFA)
measure: Fasting Insulin sensitivity
time frame: Fasting, 30 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.
description: Revised Quantitative Insulin Sensitivity Check Index (RQUICKI)
measure: Change from baseline in liver fat (Maastricht only)
time frame: 6 weeks
description: MRI (magnetic resonance imaging)
measure: Change from baseline in fasting total cholesterol
time frame: 6 weeks
description: Fasting plasma total cholesterol concentrations
measure: Change from baseline in fasting LDL cholesterol
time frame: 6 weeks
description: Fasting plasma low density lipoprotein cholesterol (LDL-C) concentrations
measure: Change from baseline in fasting Lp(a)
time frame: 6 weeks
description: Fasting plasma lipoprotein a (Lp(a))
measure: Change from baseline in fasting apoA1
time frame: 6 weeks
description: Fasting plasma apolipoprotein A1 (apoA1),
measure: Change from baseline in fasting apoB
time frame: 6 weeks
description: Fasting plasma apolipoprotein B (apo B)
measure: Change from baseline in plasma total fatty acid composition
time frame: 6 weeks
description: Fasting plasma total fatty acid composition
measure: Change from baseline in fasting glucose
time frame: 6 weeks
description: Fasting plasma glucose concentrations
measure: Change from baseline in fasting insulin
time frame: 6 weeks
description: Fasting plasma insulin concentrations
arm group label: Palmitic acid rich interesterified fat
arm group type: Experimental
description: Snacks (muffins) and spread containing palmitic acid rich interesterified fat to replace habitual snacks and spreads, and provide 10% of total daily energy intake with the interesterified fat.
arm group label: Stearic acid rich interesterified fat
arm group type: Active Comparator
description: Snacks (muffins) and spread containing stearic acid rich interesterified fat to replace habitual snacks and spreads, and provide 10% of total daily energy intake with the interesterified fat.
intervention type: Dietary Supplement
intervention name: Palmitic acid rich interesterified fat
description: Muffins and spread containing the palmitic acid rich IE fat will be consumed daily for a 6-week dietary intervention period
arm group label: Palmitic acid rich interesterified fat
intervention type: Dietary Supplement
intervention name: Stearic acid rich interesterified fat
description: Muffins and spread containing the palmitic acid rich IE fat will be consumed daily for a 6-week dietary intervention period.
arm group label: Stearic acid rich interesterified fat
criteria: 
gender: All
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Netherlands
country: United Kingdom
responsible party type: Sponsor
mesh term: Palmitic Acid
sharing ipd: No