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/NCT06042673</url>
    </required_header>
    <id_info>
      <org_study_id>UREC 22/11</org_study_id>
      <nct_id>NCT06042673</nct_id>
    </id_info>
    <brief_title>Impact of Pomegranate Seed Oil on Postprandial Cardiovascular Disease Risk Markers</brief_title>
    <official_title>Impact of Pomegranate Seed Oil on Postprandial Cardiovascular Disease Risk Markers in Postmenopausal Women.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Reading</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Reading</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>
        Dietary fat plays a crucial role as a modifiable risk factor influencing both non-fasting&#xD;
        lipaemia and vascular reactivity. Notably, the intake of dietary saturated fatty acids (SFAs)&#xD;
        has been associated with adverse effects on blood lipid profiles, whereas increased&#xD;
        consumption of unsaturated fatty acids (UFAs) has shown potential to improve lipid health.&#xD;
        Pomegranate seed oil (PSO) stands out due to its high content of conjugated α-linolenic acids&#xD;
        (CLnAs). However, research comparing the impact of these fatty acids on postprandial vascular&#xD;
        function, particularly in postmenopausal women, remains limited. A cross-over, single-blind,&#xD;
        randomised acute postprandial study will be conducted in 15 healthy postmenopausal women.&#xD;
        Participants will be assigned to consume the test meals either a placebo (50 g of mixed fat;&#xD;
        4:0.5:0.5 palm oil: rapeseed oil: safflower oil) or PSO (40 g of mixed fat and 10g of PSO) in&#xD;
        random order on 2 separate occasions, with 4-6 weeks between each study visit. The&#xD;
        anthropometric, blood pressure, and arterial stiffness, will be taken for each study visit.&#xD;
        Blood samples will be collected for the measurement of fasting lipids, glucose, insulin,&#xD;
        inflammatory markers, and whole blood culture. The findings from this study will contribute&#xD;
        to the evidence base on how consuming meals rich in PSO influence the level of blood lipids&#xD;
        as well as other biomarkers for cardiovascular disease.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 6, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline in postprandial triacylglycerol</measure>
      <time_frame>Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes</time_frame>
      <description>Triacylglycerol</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Fasting blood lipids</measure>
      <time_frame>Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes</time_frame>
      <description>Total cholesterol, high density lipoprotein cholesterol</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in postprandial insulin</measure>
      <time_frame>Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes</time_frame>
      <description>Insulin</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in postprandial endothelial activation</measure>
      <time_frame>Acute study: taken at 0 (baseline),180, 300 and 420 minutes</time_frame>
      <description>E-selectin, P-selectin, vascular cell adhesion molecule 1, intercellular adhesion molecule-1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in postprandial blood pressure</measure>
      <time_frame>Acute study: taken at 0 (baseline), 120, 240, 360 and 480 minutes</time_frame>
      <description>Systolic and diastolic blood pressure Systolic and diastolic blood pressure Systolic and diastolic blood pressure Systolic and diastolic blood pressure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline endothelial microvascular function</measure>
      <time_frame>Acute study: taken at 0 (baseline),180, 300 and 420 minutes</time_frame>
      <description>Laser Doppler imaging (LDI) with iontophoresis</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Postmenopausal Women</condition>
    <arm_group>
      <arm_group_label>Pomegranate seed oil</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be asked to consume breakfast (0 minute) containing pomegranate seed oil</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mixed vegetable oil</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will be asked to consume breakfast (0 minute) containing mixed vegetable oil</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Pomegranate seed oil</intervention_name>
      <description>10 g of pomegranate seed oil+40g mixed oil (palm oil/ rapeseed oil/ safflower oil (4:0.5:0.5)) will be added to the test meal for breakfast</description>
      <arm_group_label>Pomegranate seed oil</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Mixed vegetable oil</intervention_name>
      <description>50g mixed oil (palm oil/ rapeseed oil/ safflower oil (4:0.5:0.5)) will be added to the test meal for breakfast</description>
      <arm_group_label>mixed vegetable oil</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Postmenopausal women who have been postmenopausal for at least 12 months.&#xD;
  &#xD;
            -  Aged 65 and under years&#xD;
  &#xD;
            -  Serum TAG &lt; 2.3 mmol/l&#xD;
  &#xD;
            -  Body mass index (BMI) between 18-35 kg/m2&#xD;
  &#xD;
            -  Fasting total cholesterol &lt; 7.5 mmol/l&#xD;
  &#xD;
            -  Fasting glucose concentration &lt;7 mmol/L&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Smokers&#xD;
  &#xD;
            -  Medical history of myocardial infarction or stroke in the past 12 months&#xD;
  &#xD;
            -  Diabetes (defined as fasting glucose &gt; 7.0 mmol/l) or other endocrine disorders&#xD;
  &#xD;
            -  Kidney, liver, pancreas or gastrointestinal disorder&#xD;
  &#xD;
            -  Hypertension (blood pressure &gt; 140/90 mmHg), cancer, medication for hyperlipidaemia&#xD;
               (e.g. statins), hypertension or, inflammation&#xD;
  &#xD;
            -  Anaemia (&lt;115 g/L haemoglobin)&#xD;
  &#xD;
            -  Taking any dietary supplements known to influence lipids/gut microbiota (e.g. plant&#xD;
               stanols, fish oil, phytochemicals, natural laxatives, probiotics and prebiotics)&#xD;
  &#xD;
            -  Drinking in excess of 14 units of alcohol per week&#xD;
  &#xD;
            -  Planning on a weight-reducing regime&#xD;
  &#xD;
            -  Parallel participation in another dietary intervention study&#xD;
  &#xD;
            -  Any other unusual medical history or diet and lifestyle habits or practices that would&#xD;
               preclude volunteers from participating in a dietary intervention and metabolic study&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jeremy Spencer, BSc, PhD</last_name>
      <phone>+44(0)1183788724</phone>
      <email>j.p.e.spencer@reading.ac.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Food and Nutritional Sciences, University of Reading</name>
        <address>
          <city>Reading</city>
          <zip>RG6 6AP</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jeremy Spencer, BSc, PhD</last_name>
        <email>j.p.e.spencer@reading.ac.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 16, 2023</last_update_submitted>
    <last_update_submitted_qc>September 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Reading</investigator_affiliation>
      <investigator_full_name>Jeremy Paul Edward Spencer</investigator_full_name>
      <investigator_title>Prof</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
    </condition_browse>
    <!-- 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/NCT06042673
  org study id: UREC 22/11
  nct id: NCT06042673
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Dietary fat plays a crucial role as a modifiable risk factor influencing both non-fasting
        lipaemia and vascular reactivity. Notably, the intake of dietary saturated fatty acids (SFAs)
        has been associated with adverse effects on blood lipid profiles, whereas increased
        consumption of unsaturated fatty acids (UFAs) has shown potential to improve lipid health.
        Pomegranate seed oil (PSO) stands out due to its high content of conjugated α-linolenic acids
        (CLnAs). However, research comparing the impact of these fatty acids on postprandial vascular
        function, particularly in postmenopausal women, remains limited. A cross-over, single-blind,
        randomised acute postprandial study will be conducted in 15 healthy postmenopausal women.
        Participants will be assigned to consume the test meals either a placebo (50 g of mixed fat;
        4:0.5:0.5 palm oil: rapeseed oil: safflower oil) or PSO (40 g of mixed fat and 10g of PSO) in
        random order on 2 separate occasions, with 4-6 weeks between each study visit. The
        anthropometric, blood pressure, and arterial stiffness, will be taken for each study visit.
        Blood samples will be collected for the measurement of fasting lipids, glucose, insulin,
        inflammatory markers, and whole blood culture. The findings from this study will contribute
        to the evidence base on how consuming meals rich in PSO influence the level of blood lipids
        as well as other biomarkers for cardiovascular disease.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Change from baseline in postprandial triacylglycerol
  time frame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes
  description: Triacylglycerol
  measure: Fasting blood lipids
  time frame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes
  description: Total cholesterol, high density lipoprotein cholesterol
  measure: Change from baseline in postprandial insulin
  time frame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes
  description: Insulin
  measure: Change from baseline in postprandial endothelial activation
  time frame: Acute study: taken at 0 (baseline),180, 300 and 420 minutes
  description: E-selectin, P-selectin, vascular cell adhesion molecule 1, intercellular adhesion molecule-1
  measure: Change from baseline in postprandial blood pressure
  time frame: Acute study: taken at 0 (baseline), 120, 240, 360 and 480 minutes
  description: Systolic and diastolic blood pressure Systolic and diastolic blood pressure Systolic and diastolic blood pressure Systolic and diastolic blood pressure
  measure: Change from baseline endothelial microvascular function
  time frame: Acute study: taken at 0 (baseline),180, 300 and 420 minutes
  description: Laser Doppler imaging (LDI) with iontophoresis
  arm group label: Pomegranate seed oil
  arm group type: Experimental
  description: Participants will be asked to consume breakfast (0 minute) containing pomegranate seed oil
  arm group label: mixed vegetable oil
  arm group type: Placebo Comparator
  description: Participants will be asked to consume breakfast (0 minute) containing mixed vegetable oil
  intervention type: Dietary Supplement
  intervention name: Pomegranate seed oil
  description: 10 g of pomegranate seed oil+40g mixed oil (palm oil/ rapeseed oil/ safflower oil (4:0.5:0.5)) will be added to the test meal for breakfast
  arm group label: Pomegranate seed oil
  intervention type: Dietary Supplement
  intervention name: Mixed vegetable oil
  description: 50g mixed oil (palm oil/ rapeseed oil/ safflower oil (4:0.5:0.5)) will be added to the test meal for breakfast
  arm group label: mixed vegetable oil
  criteria: 
  gender: Female
  minimum age: N/A
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jeremy Spencer, BSc, PhD
  phone: +44(0)1183788724
  email: j.p.e.spencer@reading.ac.uk
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: University of Reading
  investigator full name: Jeremy Paul Edward Spencer
  investigator title: Prof
  mesh term: Cardiovascular Diseases