<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/NCT03025620</url>
  </required_header>
  <id_info>
    <org_study_id>Alphalinolenage</org_study_id>
    <nct_id>NCT03025620</nct_id>
  </id_info>
  <brief_title>Dietary Intake of Alpha-linolenic Acid in Elderly</brief_title>
  <official_title>Investigation of the Relationship Between Alpha-linolenic Acid and Arterial, Biochemical, Biological Parameters in Older Persons With History of Cardiovascular Events and/or Moderate Cognitive Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut Elevage</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ITERG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>SAINT HUBERT</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>TERRES UNIVIA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>TERRES INOVIA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the antiatherogenic and anti-inflammatory potential&#xD;
      of an adequate intake of alpha-linolenic acid in elderly.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is growing evidence that diets high in long chain n-3 polyunsaturated fatty acids&#xD;
      (PUFA) decrease the risk of fatal ischemic heart disease.Both epidemiologic studies and&#xD;
      clinical trials demonstrate substantial cardioprotective effects of alpha linolenic acid&#xD;
      (ALA) from vegetable oils.However, little is known about the relation of the dietary intake&#xD;
      of ALA with ischemic heart disease among older adults.In this study, elderly volunteers will&#xD;
      be asked to ingest a supplement of a vegetable oil providing 1g of ALA, or an equivalent&#xD;
      amount of linoleic acid as sunflower oil, for a diet period of 6 weeks.Serum samples will be&#xD;
      collected before the dietary intervention and 6 weeks later.Plasma biomarkers of&#xD;
      inflammatory, lipid cardiovascular risk factors and serum and red cell membrane fatty acid&#xD;
      composition will be determined on all samples.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2006</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">February 2011</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>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effects of diet supplementation on fatty acid composition in serum and red cell membrane phospholipids, at the end of dietary period</measure>
    <time_frame>6 weeks</time_frame>
    <description>Blood samples have been done at the beginning and at the end of the dietary period. Fatty acids analyses of the red cells and serum have been performed by GC method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pulse wave velocity (PWV)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Pulse wave velocity values have been performed at the beginning and the end of the dietary period.&#xD;
The purpose was to evaluate the relationship between PWV and dietary intakes of ALA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Others</measure>
    <time_frame>6 weeks</time_frame>
    <description>ApoB ApoA1 Oxydative parameters (ie CRP) Lp(a)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">254</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Inflammation</condition>
  <condition>Metabolism Disorder, Lipid</condition>
  <arm_group>
    <arm_group_label>Sunflower arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants were supplied with the usual diet of the hospital, daily enriched with 17.5g fat as follows during 42 days: 10 g of sunflower oil (with a high content in linoleic acid) were added into the dinner soup and 7.5g delivered through a 12.5g portion of margarine made with sunflower oil (60% fat) that replaced butter on the breakfast toasts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rapeseed arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants were supplied with the usual diet of the hospital, daily enriched with 17.5g fat as follows during 42 days: 10 g of rapeseed oil (with a high content in alpha-linolenic acid) were added into the dinner soup and 7.5g delivered through a 12.5g portion of margarine made with rapeseed oil (60% fat) that replaced butter on the breakfast toasts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Rapeseed oil</intervention_name>
    <description>Active comparator arm : Dietary Supplement: rapeseed oil supplementation (10g per day) and margarine with a high level of alpha-linolenic acid (12.5g per day) during 42 days.</description>
    <arm_group_label>Rapeseed arm</arm_group_label>
    <other_name>Alpha-linolenic acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sunflower oil</intervention_name>
    <description>Placebo comparator arm : Dietary Supplement: sunflower oil supplementation (10g per day) and margarine with a high level of inoleic acid (12.5g per day) during 42 days.</description>
    <arm_group_label>Sunflower arm</arm_group_label>
    <other_name>Linoleic acid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elderly patients over 65 years old exhibiting clinical indices of cardiovascular&#xD;
             disease&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Subjects who were hospitalized in the Geriatric Unit of the Emile Roux Hospital&#xD;
             (AP-HP)&#xD;
&#xD;
          -  MMSE (Mini Mental State Examination)score &gt; or = 15&#xD;
&#xD;
          -  Supervision available for study medication&#xD;
&#xD;
          -  Able to ingest oral diet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to understand the objectives of the dietary intervention&#xD;
&#xD;
          -  Patients in paliative care&#xD;
&#xD;
          -  Patients receiving supplement diets&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>olivier henry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique de Paris. Hopital Emile Roux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>hopital Emile Roux</name>
      <address>
        <city>Limeil Brevannes</city>
        <zip>94450</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Giallauria F, Vigorito C, Tramarin R, Fattirolli F, Ambrosetti M, De Feo S, Griffo R, Riccio C, Piepoli M; ISYDE-2008 Investigators of the Italian Association for Cardiovascular Prevention, Rehabilitation, and Prevention. Cardiac rehabilitation in very old patients: data from the Italian Survey on Cardiac Rehabilitation-2008 (ISYDE-2008)--official report of the Italian Association for Cardiovascular Prevention, Rehabilitation, and Epidemiology. J Gerontol A Biol Sci Med Sci. 2010 Dec;65(12):1353-61. doi: 10.1093/gerona/glq138. Epub 2010 Jul 28.</citation>
    <PMID>20667934</PMID>
  </reference>
  <reference>
    <citation>Rodriguez-Leyva D, Dupasquier CM, McCullough R, Pierce GN. The cardiovascular effects of flaxseed and its omega-3 fatty acid, alpha-linolenic acid. Can J Cardiol. 2010 Nov;26(9):489-96. doi: 10.1016/s0828-282x(10)70455-4.</citation>
    <PMID>21076723</PMID>
  </reference>
  <reference>
    <citation>Salva A, Corman B, Andrieu S, Salas J, Vellas B; International Association Of Gerontology/International Academy Of Nutrition And Aging Task Force. Minimum data set for nutritional intervention studies in elderly people. J Gerontol A Biol Sci Med Sci. 2004 Jul;59(7):724-9. doi: 10.1093/gerona/59.7.m724.</citation>
    <PMID>15304539</PMID>
  </reference>
  <reference>
    <citation>Bischoff HA, Staehelin HB, Willett WC. The effect of undernutrition in the development of frailty in older persons. J Gerontol A Biol Sci Med Sci. 2006 Jun;61(6):585-9. doi: 10.1093/gerona/61.6.585. No abstract available.</citation>
    <PMID>16799140</PMID>
  </reference>
  <reference>
    <citation>Abbatecola AM, Cherubini A, Guralnik JM, Andres Lacueva C, Ruggiero C, Maggio M, Bandinelli S, Paolisso G, Ferrucci L. Plasma polyunsaturated fatty acids and age-related physical performance decline. Rejuvenation Res. 2009 Feb;12(1):25-32. doi: 10.1089/rej.2008.0799.</citation>
    <PMID>19196012</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assistance Publique - Hôpitaux de Paris</investigator_affiliation>
    <investigator_full_name>Fathi Driss</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>Alphalinolenic acid</keyword>
  <keyword>Lipid cardiovascular risk factors</keyword>
  <keyword>Inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Lipid Metabolism Disorders</mesh_term>
    <mesh_term>Inflammation</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/NCT03025620
org study id: Alphalinolenage
nct id: NCT03025620
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the antiatherogenic and anti-inflammatory potential
      of an adequate intake of alpha-linolenic acid in elderly.
There is growing evidence that diets high in long chain n-3 polyunsaturated fatty acids
      (PUFA) decrease the risk of fatal ischemic heart disease.Both epidemiologic studies and
      clinical trials demonstrate substantial cardioprotective effects of alpha linolenic acid
      (ALA) from vegetable oils.However, little is known about the relation of the dietary intake
      of ALA with ischemic heart disease among older adults.In this study, elderly volunteers will
      be asked to ingest a supplement of a vegetable oil providing 1g of ALA, or an equivalent
      amount of linoleic acid as sunflower oil, for a diet period of 6 weeks.Serum samples will be
      collected before the dietary intervention and 6 weeks later.Plasma biomarkers of
      inflammatory, lipid cardiovascular risk factors and serum and red cell membrane fatty acid
      composition will be determined on all samples.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Effects of diet supplementation on fatty acid composition in serum and red cell membrane phospholipids, at the end of dietary period
time frame: 6 weeks
description: Blood samples have been done at the beginning and at the end of the dietary period. Fatty acids analyses of the red cells and serum have been performed by GC method.
measure: Pulse wave velocity (PWV)
time frame: 6 weeks
description: Pulse wave velocity values have been performed at the beginning and the end of the dietary period.
The purpose was to evaluate the relationship between PWV and dietary intakes of ALA.
measure: Others
time frame: 6 weeks
description: ApoB ApoA1 Oxydative parameters (ie CRP) Lp(a)
arm group label: Sunflower arm
arm group type: Placebo Comparator
description: Participants were supplied with the usual diet of the hospital, daily enriched with 17.5g fat as follows during 42 days: 10 g of sunflower oil (with a high content in linoleic acid) were added into the dinner soup and 7.5g delivered through a 12.5g portion of margarine made with sunflower oil (60% fat) that replaced butter on the breakfast toasts.
arm group label: Rapeseed arm
arm group type: Active Comparator
description: Participants were supplied with the usual diet of the hospital, daily enriched with 17.5g fat as follows during 42 days: 10 g of rapeseed oil (with a high content in alpha-linolenic acid) were added into the dinner soup and 7.5g delivered through a 12.5g portion of margarine made with rapeseed oil (60% fat) that replaced butter on the breakfast toasts.
intervention type: Dietary Supplement
intervention name: Rapeseed oil
description: Active comparator arm : Dietary Supplement: rapeseed oil supplementation (10g per day) and margarine with a high level of alpha-linolenic acid (12.5g per day) during 42 days.
arm group label: Rapeseed arm
other name: Alpha-linolenic acid
intervention type: Dietary Supplement
intervention name: Sunflower oil
description: Placebo comparator arm : Dietary Supplement: sunflower oil supplementation (10g per day) and margarine with a high level of inoleic acid (12.5g per day) during 42 days.
arm group label: Sunflower arm
other name: Linoleic acid
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: olivier henry, MD
role: Principal Investigator
affiliation: Assistance Publique de Paris. Hopital Emile Roux
facility: 
country: France
citation: Giallauria F, Vigorito C, Tramarin R, Fattirolli F, Ambrosetti M, De Feo S, Griffo R, Riccio C, Piepoli M; ISYDE-2008 Investigators of the Italian Association for Cardiovascular Prevention, Rehabilitation, and Prevention. Cardiac rehabilitation in very old patients: data from the Italian Survey on Cardiac Rehabilitation-2008 (ISYDE-2008)--official report of the Italian Association for Cardiovascular Prevention, Rehabilitation, and Epidemiology. J Gerontol A Biol Sci Med Sci. 2010 Dec;65(12):1353-61. doi: 10.1093/gerona/glq138. Epub 2010 Jul 28.
PMID: 20667934
citation: Rodriguez-Leyva D, Dupasquier CM, McCullough R, Pierce GN. The cardiovascular effects of flaxseed and its omega-3 fatty acid, alpha-linolenic acid. Can J Cardiol. 2010 Nov;26(9):489-96. doi: 10.1016/s0828-282x(10)70455-4.
PMID: 21076723
citation: Salva A, Corman B, Andrieu S, Salas J, Vellas B; International Association Of Gerontology/International Academy Of Nutrition And Aging Task Force. Minimum data set for nutritional intervention studies in elderly people. J Gerontol A Biol Sci Med Sci. 2004 Jul;59(7):724-9. doi: 10.1093/gerona/59.7.m724.
PMID: 15304539
citation: Bischoff HA, Staehelin HB, Willett WC. The effect of undernutrition in the development of frailty in older persons. J Gerontol A Biol Sci Med Sci. 2006 Jun;61(6):585-9. doi: 10.1093/gerona/61.6.585. No abstract available.
PMID: 16799140
citation: Abbatecola AM, Cherubini A, Guralnik JM, Andres Lacueva C, Ruggiero C, Maggio M, Bandinelli S, Paolisso G, Ferrucci L. Plasma polyunsaturated fatty acids and age-related physical performance decline. Rejuvenation Res. 2009 Feb;12(1):25-32. doi: 10.1089/rej.2008.0799.
PMID: 19196012
responsible party type: Principal Investigator
investigator affiliation: Assistance Publique - Hôpitaux de Paris
investigator full name: Fathi Driss
investigator title: Doctor
mesh term: Cardiovascular Diseases
mesh term: Metabolic Diseases
mesh term: Lipid Metabolism Disorders
mesh term: Inflammation
sharing ipd: No