<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/NCT01665742</url>
  </required_header>
  <id_info>
    <org_study_id>TNS-5</org_study_id>
    <nct_id>NCT01665742</nct_id>
  </id_info>
  <brief_title>Anti-inflammatory Dietary Intervention in Overweight and Obese Adolescents</brief_title>
  <official_title>Novel Anti-inflammatory Dietary Intervention to Improve the Metabolic Phenotype of Overweight and Obese 13-18 Year Old Adolescents - Insights Into Potential Genetic Susceptibility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College Dublin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Children's Research Centre, Ireland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Dublin, Trinity College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Adelaide and Meath Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. James's Hospital, Ireland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University College Dublin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The number of overweight and obese children has increased in Ireland at a greater rate than&#xD;
      worldwide trends. The poor eating patterns that drive adolescent obesity leads to an increase&#xD;
      in the number of unhealthy inflammatory hormones and fats circulating in the blood which&#xD;
      increase an adolescent's risk of developing diabetes and heart disease later in life. Dietary&#xD;
      patterns have changed whereby key nutrients that are found in fruit, vegetables and fish,&#xD;
      which are known to have beneficial effects and reduce risk of obesity and diabetes in later&#xD;
      life, may need to be replaced. This project will determine whether a key anti-inflammatory&#xD;
      nutrient supplement taken for 8 weeks will improve the metabolic profile of adolescents aged&#xD;
      13-18 years old. Detailed cellular analysis will determine the cellular and molecular&#xD;
      mechanisms to provide a thorough explanation of the health effects of this intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The emerging model of obesity and diabetes is characterised by sub-acute chronic inflammation&#xD;
      and insulin resistance. Mechanistic data indicates inflamed adipose tissue with increased&#xD;
      infiltration of immune cells that generate pro-inflammatory cytokines. With childhood obesity&#xD;
      in Ireland increasing at a rapid pace, it is important to establish the role of a&#xD;
      non-pharmacological dietary approach to decreasing the sub-acute chronic inflammation seen in&#xD;
      overweight and obese children. Several foods contain nutrients that are known to have&#xD;
      anti-inflammatory properties. Such foods including fish, fruits and vegetables are known to&#xD;
      be deplete in the adolescent diet. The aim of this project is to investigate whether a&#xD;
      nutritional supplement containing anti-inflammatory nutrients, n-3 polyunsaturated fatty&#xD;
      acids (found in fish oil), vitamin C, vitamin E, and polyphenols found in green tea and&#xD;
      tomato; will improve metabolic phenotype in 13-18 year old teenagers over an 8-week period.&#xD;
      Further, to provide insight into the role of genetics in the development of metabolic&#xD;
      dysregulation and response to dietary treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Homeostasis model of assessment - insulin resistance</measure>
    <time_frame>8 weeks</time_frame>
    <description>Homeostasis model of assessment - insulin resistance (HOMA-IR) will be derived from fasting glucose and insulin concentrations [(fasting plasma glucose x fasting serum insulin)/22.5] as determined by Matthews et al., 1985</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adiponectin</measure>
    <time_frame>8 weeks</time_frame>
    <description>Adiponectin, a marker of insulin sensitivity, will be determined pre- and post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of inflammation</measure>
    <time_frame>8 weeks</time_frame>
    <description>Markers of inflammation such as C reactive protein, interleukin (IL) - 6, IL-1β, tumour necrosis factor alpha, intra-cellular adhesion molecule-1, vascular cell adhesion molecule-1, retinol binding protein 4, fibrinogen, white blood cells and related inflammatory markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid Profile</measure>
    <time_frame>8 weeks</time_frame>
    <description>Full lipid profile and lipidomic analyses (total triacylglycerol, non-esterified fatty acids, total cholesterol, LDL cholesterol, HDL cholesterol and plasma fatty acid composition, diglycerides, cholesterol esters and sphingomyelins,) and related lipid markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory genetic variants</measure>
    <time_frame>8 weeks</time_frame>
    <description>Inflammatory genetic variants such as complement component 3, lymphotoxin- α, IL-6, IL-1β, TNF-α, adiponectin polymorphisms and related variants that link to the inflammatory phenotype</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional molecular analysis (ex-vivo)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Functional molecular analysis will be conducted to determine which insulin sensitising pathways have been modulated by the intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Anti-inflammatory supplement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>8-weeks of daily supplementation with:&#xD;
1 x fruit juice fortified with fish oil, and 4 x film-coated tablets containing vitamin C, alpha-tocopherol, green tea extract and lycopene&#xD;
in conjunction with a weight management programme</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo supplement</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>8 weeks of daily supplementation with:&#xD;
1 x fruit juice fortified with high-oleic sunflower oil, and 4 x film-coated placebo tablets&#xD;
in conjunction with a weight management programme</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopene</intervention_name>
    <description>1 x fruit juice fortified with salmon oil containing 1000mg EPA and 1000mg DHA daily for 8 weeks&#xD;
AND&#xD;
4 x film-coated tablets containing 561mg vitamin C, 389mg alpha-tocopherol, 416mg green tea extract and 15mg lycopene daily for 8 weeks&#xD;
in conjunction with a weight management programme</description>
    <arm_group_label>Anti-inflammatory supplement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo supplement</intervention_name>
    <description>1 x fruit juice fortified fortified with high oleic sunflower oil daily for 8 weeks&#xD;
AND&#xD;
4 x film-coated placebo tablets daily for 8 weeks&#xD;
in conjunction with a weight management programme</description>
    <arm_group_label>Placebo supplement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female&#xD;
&#xD;
          2. 13-18 years&#xD;
&#xD;
          3. Body mass index ≥ 91st percentile on UK growth reference charts (Cole, 1995)&#xD;
&#xD;
          4. Medications/dietary supplements which do not interfere with the intervention are&#xD;
             allowed, on condition that the participants adhere to the same regimen during the&#xD;
             intervention, including oral contraceptives and other non-fatty acid based dietary&#xD;
             supplements (e.g. garlic)&#xD;
&#xD;
          5. Smoker or non-smoker&#xD;
&#xD;
          6. Not participating in any other intervention study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or lactation&#xD;
&#xD;
          2. Endocrine disorders such as Polycystic Ovary Syndrome&#xD;
&#xD;
          3. Currently on treatment for a chronic inflammatory condition such as asthma&#xD;
&#xD;
          4. Kidney or liver dysfunction&#xD;
&#xD;
          5. Iron deficiency anaemia&#xD;
&#xD;
          6. Prescribed anti-inflammatory medication&#xD;
&#xD;
          7. Consumers of fatty acid supplements including fish oils, evening primrose oil and&#xD;
             antioxidant vitamin (A, C, E, -carotene) supplements&#xD;
&#xD;
          8. High consumers of oily fish (&gt; 2 servings/week)&#xD;
&#xD;
          9. Participants planning to start a special diet or lose weight (e.g. Slimfast, Atkins&#xD;
             etc)&#xD;
&#xD;
         10. Weight change ≥3kg within the last 3 months&#xD;
&#xD;
         11. Alcohol or drug abuse (based on clinical judgement)&#xD;
&#xD;
         12. Participants with an allergy to fish and/or shellfish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helen M Roche, BSc, MSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University College Dublin</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fiona Lithander, BSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Dublin, Trinity College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Trinity Centre for Health Sciences, St, James's Hospital</name>
      <address>
        <city>Dublin 8</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adelaide and Meath Hospital, Incorporating the National Children's Hospital Dublin,</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College Dublin</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>December 5, 2014</last_update_submitted>
  <last_update_submitted_qc>December 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University College Dublin</investigator_affiliation>
    <investigator_full_name>Prof Helen M Roche</investigator_full_name>
    <investigator_title>Associate Professor of Nutrigenomics</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Chronic inflammation</keyword>
  <keyword>Anti-inflammatory dietary intervention</keyword>
  <keyword>Genetic susceptibility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tocopherols</mesh_term>
    <mesh_term>Vitamin E</mesh_term>
    <mesh_term>alpha-Tocopherol</mesh_term>
    <mesh_term>Lycopene</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01665742
org study id: TNS-5
nct id: NCT01665742
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The number of overweight and obese children has increased in Ireland at a greater rate than
      worldwide trends. The poor eating patterns that drive adolescent obesity leads to an increase
      in the number of unhealthy inflammatory hormones and fats circulating in the blood which
      increase an adolescent's risk of developing diabetes and heart disease later in life. Dietary
      patterns have changed whereby key nutrients that are found in fruit, vegetables and fish,
      which are known to have beneficial effects and reduce risk of obesity and diabetes in later
      life, may need to be replaced. This project will determine whether a key anti-inflammatory
      nutrient supplement taken for 8 weeks will improve the metabolic profile of adolescents aged
      13-18 years old. Detailed cellular analysis will determine the cellular and molecular
      mechanisms to provide a thorough explanation of the health effects of this intervention.
The emerging model of obesity and diabetes is characterised by sub-acute chronic inflammation
      and insulin resistance. Mechanistic data indicates inflamed adipose tissue with increased
      infiltration of immune cells that generate pro-inflammatory cytokines. With childhood obesity
      in Ireland increasing at a rapid pace, it is important to establish the role of a
      non-pharmacological dietary approach to decreasing the sub-acute chronic inflammation seen in
      overweight and obese children. Several foods contain nutrients that are known to have
      anti-inflammatory properties. Such foods including fish, fruits and vegetables are known to
      be deplete in the adolescent diet. The aim of this project is to investigate whether a
      nutritional supplement containing anti-inflammatory nutrients, n-3 polyunsaturated fatty
      acids (found in fish oil), vitamin C, vitamin E, and polyphenols found in green tea and
      tomato; will improve metabolic phenotype in 13-18 year old teenagers over an 8-week period.
      Further, to provide insight into the role of genetics in the development of metabolic
      dysregulation and response to dietary treatment.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Homeostasis model of assessment - insulin resistance
time frame: 8 weeks
description: Homeostasis model of assessment - insulin resistance (HOMA-IR) will be derived from fasting glucose and insulin concentrations [(fasting plasma glucose x fasting serum insulin)/22.5] as determined by Matthews et al., 1985
measure: Adiponectin
time frame: 8 weeks
description: Adiponectin, a marker of insulin sensitivity, will be determined pre- and post-intervention.
measure: Markers of inflammation
time frame: 8 weeks
description: Markers of inflammation such as C reactive protein, interleukin (IL) - 6, IL-1β, tumour necrosis factor alpha, intra-cellular adhesion molecule-1, vascular cell adhesion molecule-1, retinol binding protein 4, fibrinogen, white blood cells and related inflammatory markers
measure: Lipid Profile
time frame: 8 weeks
description: Full lipid profile and lipidomic analyses (total triacylglycerol, non-esterified fatty acids, total cholesterol, LDL cholesterol, HDL cholesterol and plasma fatty acid composition, diglycerides, cholesterol esters and sphingomyelins,) and related lipid markers
measure: Inflammatory genetic variants
time frame: 8 weeks
description: Inflammatory genetic variants such as complement component 3, lymphotoxin- α, IL-6, IL-1β, TNF-α, adiponectin polymorphisms and related variants that link to the inflammatory phenotype
measure: Functional molecular analysis (ex-vivo)
time frame: 8 weeks
description: Functional molecular analysis will be conducted to determine which insulin sensitising pathways have been modulated by the intervention
arm group label: Anti-inflammatory supplement
arm group type: Active Comparator
description: 8-weeks of daily supplementation with:
1 x fruit juice fortified with fish oil, and 4 x film-coated tablets containing vitamin C, alpha-tocopherol, green tea extract and lycopene
in conjunction with a weight management programme
arm group label: Placebo supplement
arm group type: Placebo Comparator
description: 8 weeks of daily supplementation with:
1 x fruit juice fortified with high-oleic sunflower oil, and 4 x film-coated placebo tablets
in conjunction with a weight management programme
intervention type: Dietary Supplement
intervention name: Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopene
description: 1 x fruit juice fortified with salmon oil containing 1000mg EPA and 1000mg DHA daily for 8 weeks
AND
4 x film-coated tablets containing 561mg vitamin C, 389mg alpha-tocopherol, 416mg green tea extract and 15mg lycopene daily for 8 weeks
in conjunction with a weight management programme
arm group label: Anti-inflammatory supplement
intervention type: Dietary Supplement
intervention name: Placebo supplement
description: 1 x fruit juice fortified fortified with high oleic sunflower oil daily for 8 weeks
AND
4 x film-coated placebo tablets daily for 8 weeks
in conjunction with a weight management programme
arm group label: Placebo supplement
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: No
last name: Helen M Roche, BSc, MSc, PhD
role: Principal Investigator
affiliation: University College Dublin
last name: Fiona Lithander, BSc, PhD
role: Principal Investigator
affiliation: University of Dublin, Trinity College
facility: 
facility: 
facility: 
country: Ireland
responsible party type: Principal Investigator
investigator affiliation: University College Dublin
investigator full name: Prof Helen M Roche
investigator title: Associate Professor of Nutrigenomics
mesh term: Overweight
mesh term: Tocopherols
mesh term: Vitamin E
mesh term: alpha-Tocopherol
mesh term: Lycopene