<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/NCT02210767</url>
  </required_header>
  <id_info>
    <org_study_id>PKE ALA</org_study_id>
    <nct_id>NCT02210767</nct_id>
  </id_info>
  <brief_title>Effects of Walnuts on Central Blood Pressure, Arterial Stiffness Indices, Lipoproteins, and Other CVD Risk Factors</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>California Walnut Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Penn State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the effects of walnut-derived ALA and bioactives on multiple CVD&#xD;
      risk factors, including central blood pressure, arterial stiffness indices, inflammatory&#xD;
      markers, urinary isoprostanes, vascular adhesion markers, and changes in lipids and&#xD;
      lipoproteins. Gut microbiome changes due to walnut consumption will also be assessed using&#xD;
      the 16S rRNA gene.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diets containing nuts likely reduce cardiovascular disease (CVD) risk but the mechanisms&#xD;
      remain poorly defined. Walnuts contain substantial amounts of polyunsaturated fatty acids&#xD;
      (PUFAs), particularly alpha-linolenic acid (ALA), and are a rich source of bioactives. Many&#xD;
      vegetable oils are high in PUFAs but most lack ALA and do not provide the same complement of&#xD;
      bioactive compounds as walnuts. ALA is thought to improve cardiovascular health by modulating&#xD;
      circulating lipid concentrations, altering membrane structure/function by enhancing the total&#xD;
      ω-3 fatty acid content of cell membrane phospholipids, and reducing inflammatory reactions by&#xD;
      inhibiting production of arachidonic acid-derived eicosanoids. Consumption of walnuts has&#xD;
      consistently been shown to improve blood lipids/lipoproteins and vascular health. However,&#xD;
      there remains much debate over what is the preferable replacement for saturated fat in the&#xD;
      diet. Because of the ALA and bioactives that they provide, walnuts may confer specific CVD&#xD;
      benefits. To study the effects of walnuts, in terms of both their ALA content and bioactive&#xD;
      compounds, we will compare two test diets (one containing walnuts and one matched for PUFA&#xD;
      and ALA content but devoid of walnuts and their bioactives) to a control diet matched for&#xD;
      macronutrient and linoleic acid (LA) content but providing oleic acid in place of ALA. This&#xD;
      diet design will provide information about how walnuts affect the selected endpoints of&#xD;
      interest due to their bioactives as well as their ALA content, and whether walnut ALA is a&#xD;
      superior substitute for dietary saturated fat compared to oleic acid.&#xD;
&#xD;
      Feeding protocol and study treatments:&#xD;
&#xD;
      This study is designed as a double-blind, 3-period, randomized, cross-over controlled feeding&#xD;
      study. Prior to randomization, participants will complete a two week run-in on a standard&#xD;
      Western diet. Each diet period treatment phase will be 6 weeks in duration, separated by&#xD;
      2-week washout periods. The three test diets are: 1) a walnut diet (WD; providing ~2.0 oz of&#xD;
      walnuts per day); 2) a matched walnut control diet (WCD) that will provide the same fatty&#xD;
      acid profile as the walnut diet, but will not contain walnuts (and their bioactives); and 3)&#xD;
      a low ALA diet (LAD) with a similar macronutrient (and linoleic acid) composition as the WD&#xD;
      and WCD, but using oleic acid to replace ALA. Study diets will be prepared in a metabolic&#xD;
      kitchen, with three isocaloric meals and a snack provided each day, based on a 7-day rotating&#xD;
      menu cycle. Participants will be instructed to consume only the prepared foods and limit&#xD;
      their intake of alcohol to 2 drinks/week and caffeinated calorie-free beverages to 40 ounces&#xD;
      (5 drinks) per day. Diets will be planned for every subject according to his/her energy&#xD;
      requirements and will be nutritionally adequate. This diet design will permit the WD to be&#xD;
      compared with the WCD and LAD and, thereby, allow us to ascertain the specific effects that&#xD;
      walnuts and their bioactive components (including and beyond ALA) may have on CVD risk&#xD;
      factors and artery health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in central blood pressure at the end of diet period 1 (week 6), end of diet period 2 (week 14), and end of diet period 3 (week 22)</measure>
    <time_frame>End of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in 24-hour ambulatory blood pressure</measure>
    <time_frame>Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in indices of arterial stiffness (pulse wave velocity)</measure>
    <time_frame>Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lipoprotein particle size</measure>
    <time_frame>Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)</time_frame>
    <description>The VAP© Test provides a direct measure of the following lipid and lipoprotein classes and subclasses: LDL, Lp(a), IDL, LDL1, LDL2, LDL3, LDL4, HDL, HDL2, HDL3, VLDL, VLDL1+2, VLDL3, TC, TG, Non-HDL, Remnant Lipoproteins, ApoB100, and ApoA1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in inflammatory cytokines (tumor necrosis factor-alpha and interleukin-6)</measure>
    <time_frame>Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the composition of the gut microbiome</measure>
    <time_frame>Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)</time_frame>
    <description>This will be assessed via sequencing of microbial 16S rRNA from fecal samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum C-reactive protein</measure>
    <time_frame>Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum glucose</measure>
    <time_frame>Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum insulin</measure>
    <time_frame>Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in urinary F2α-isoprostanes</measure>
    <time_frame>Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lipid/lipoprotein profile</measure>
    <time_frame>Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)</time_frame>
    <description>Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate variability</measure>
    <time_frame>Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in vascular adhesion markers (VCAM and ICAM)</measure>
    <time_frame>Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Walnut Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Provides ~2 oz. walnuts/day (2-3% of total calories from alpha-linolenic acid [ALA])</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Walnut Control Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Provides same fatty acid profile (&lt;7% SFA, 9% MUFA, 14-15% PUFA, 2-3% ALA) as Walnut Diet, but is devoid of walnuts and their bioactives</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low ALA Diet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Provides similar macronutrient and linoleic acid profile but replaces ALA with oleic acid (&lt;7% SFA, 12% MUFA, 12% PUFA, 0.5% ALA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Walnut Diet</intervention_name>
    <description>2 oz. walnuts/day (2-3% of total calories from ALA)</description>
    <arm_group_label>Walnut Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Walnut Control Diet</intervention_name>
    <description>2-3% ALA but no walnuts provided</description>
    <arm_group_label>Walnut Control Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low ALA Diet</intervention_name>
    <description>ALA replaced by oleic acid</description>
    <arm_group_label>Low ALA Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 30-65 years&#xD;
&#xD;
          -  BMI greater than 25 and less than or equal to 40 kg/m2&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  TG &lt; 350 mg/dL&#xD;
&#xD;
          -  LDL-C between the 25-95th percentile from NHANES:&#xD;
&#xD;
          -  Males: 105-194 mg/dL&#xD;
&#xD;
          -  Females: 98-190 mg/dL&#xD;
&#xD;
          -  Stage I hypertension:&#xD;
&#xD;
          -  SBP &gt; 120 mmHg and/or DBP &gt; 80 mmHg&#xD;
&#xD;
          -  SBP &lt; 160 mmHg and DBP &lt; 100 mmHg&#xD;
&#xD;
          -  Free of established CVD, stroke, diabetes, liver, kidney or autoimmune disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Elevated BP (SBP ≥160 mmHg OR DBP ≥ 100 mmHg)&#xD;
&#xD;
          -  A history of myocardial infarction, stroke, diabetes mellitus, liver disease,&#xD;
             inflammatory disease, kidney disease, and/or thyroid disease (unless controlled on&#xD;
             medication).&#xD;
&#xD;
          -  Blood pressure or cholesterol-lowering medication use&#xD;
&#xD;
          -  Refusal to discontinue intake of putative cholesterol-lowering supplements (psyllium,&#xD;
             fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens).&#xD;
&#xD;
          -  Vegetarianism or other dietary practices that are inconsistent with the test diets&#xD;
&#xD;
          -  Nut allergies (Other food allergies will be reviewed on a case-by-case basis)&#xD;
&#xD;
          -  Refusal to discontinue nutritional supplements, herbs, vitamins or NSAID's&#xD;
&#xD;
          -  Latex allergy&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Penn State University</name>
      <address>
        <city>University Park</city>
        <state>Pennsylvania</state>
        <zip>16802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>McGuire S. U.S. Department of Agriculture and U.S. Department of Health and Human Services, Dietary Guidelines for Americans, 2010. 7th Edition, Washington, DC: U.S. Government Printing Office, January 2011. Adv Nutr. 2011 May;2(3):293-4. doi: 10.3945/an.111.000430. Epub 2011 Apr 30. No abstract available.</citation>
    <PMID>22332062</PMID>
  </reference>
  <reference>
    <citation>Sabate J, Fraser GE, Burke K, Knutsen SF, Bennett H, Lindsted KD. Effects of walnuts on serum lipid levels and blood pressure in normal men. N Engl J Med. 1993 Mar 4;328(9):603-7. doi: 10.1056/NEJM199303043280902.</citation>
    <PMID>8357360</PMID>
  </reference>
  <reference>
    <citation>Zhao G, Etherton TD, Martin KR, West SG, Gillies PJ, Kris-Etherton PM. Dietary alpha-linolenic acid reduces inflammatory and lipid cardiovascular risk factors in hypercholesterolemic men and women. J Nutr. 2004 Nov;134(11):2991-7. doi: 10.1093/jn/134.11.2991.</citation>
    <PMID>15514264</PMID>
  </reference>
  <reference>
    <citation>Banel DK, Hu FB. Effects of walnut consumption on blood lipids and other cardiovascular risk factors: a meta-analysis and systematic review. Am J Clin Nutr. 2009 Jul;90(1):56-63. doi: 10.3945/ajcn.2009.27457. Epub 2009 May 20.</citation>
    <PMID>19458020</PMID>
  </reference>
  <reference>
    <citation>West SG, Krick AL, Klein LC, Zhao G, Wojtowicz TF, McGuiness M, Bagshaw DM, Wagner P, Ceballos RM, Holub BJ, Kris-Etherton PM. Effects of diets high in walnuts and flax oil on hemodynamic responses to stress and vascular endothelial function. J Am Coll Nutr. 2010 Dec;29(6):595-603. doi: 10.1080/07315724.2010.10719898.</citation>
    <PMID>21677123</PMID>
  </reference>
  <reference>
    <citation>Estruch R, Ros E, Salas-Salvadó J, Covas MI, Corella D, Arós F, Gómez-Gracia E, Ruiz-Gutiérrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L,Pintó X, Basora J, Muñoz MA, Sorlí JV, Martínez JA, Martínez-González MA; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013;368:1279-1290.</citation>
  </reference>
  <reference>
    <citation>Zhang J, Grieger JA, Kris-Etherton PM, Thompson JT, Gillies PJ, Fleming JA, Vanden Heuvel JP. Walnut oil increases cholesterol efflux through inhibition of stearoyl CoA desaturase 1 in THP-1 macrophage-derived foam cells. Nutr Metab (Lond). 2011 Aug 26;8:61. doi: 10.1186/1743-7075-8-61.</citation>
    <PMID>21871057</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 16, 2023</last_update_submitted>
  <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>


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/NCT02210767
org study id: PKE ALA
nct id: NCT02210767
lead sponsor: 
collaborator: 
has dmc: No
This study will evaluate the effects of walnut-derived ALA and bioactives on multiple CVD
      risk factors, including central blood pressure, arterial stiffness indices, inflammatory
      markers, urinary isoprostanes, vascular adhesion markers, and changes in lipids and
      lipoproteins. Gut microbiome changes due to walnut consumption will also be assessed using
      the 16S rRNA gene.
Diets containing nuts likely reduce cardiovascular disease (CVD) risk but the mechanisms
      remain poorly defined. Walnuts contain substantial amounts of polyunsaturated fatty acids
      (PUFAs), particularly alpha-linolenic acid (ALA), and are a rich source of bioactives. Many
      vegetable oils are high in PUFAs but most lack ALA and do not provide the same complement of
      bioactive compounds as walnuts. ALA is thought to improve cardiovascular health by modulating
      circulating lipid concentrations, altering membrane structure/function by enhancing the total
      ω-3 fatty acid content of cell membrane phospholipids, and reducing inflammatory reactions by
      inhibiting production of arachidonic acid-derived eicosanoids. Consumption of walnuts has
      consistently been shown to improve blood lipids/lipoproteins and vascular health. However,
      there remains much debate over what is the preferable replacement for saturated fat in the
      diet. Because of the ALA and bioactives that they provide, walnuts may confer specific CVD
      benefits. To study the effects of walnuts, in terms of both their ALA content and bioactive
      compounds, we will compare two test diets (one containing walnuts and one matched for PUFA
      and ALA content but devoid of walnuts and their bioactives) to a control diet matched for
      macronutrient and linoleic acid (LA) content but providing oleic acid in place of ALA. This
      diet design will provide information about how walnuts affect the selected endpoints of
      interest due to their bioactives as well as their ALA content, and whether walnut ALA is a
      superior substitute for dietary saturated fat compared to oleic acid.

      Feeding protocol and study treatments:

      This study is designed as a double-blind, 3-period, randomized, cross-over controlled feeding
      study. Prior to randomization, participants will complete a two week run-in on a standard
      Western diet. Each diet period treatment phase will be 6 weeks in duration, separated by
      2-week washout periods. The three test diets are: 1) a walnut diet (WD; providing ~2.0 oz of
      walnuts per day); 2) a matched walnut control diet (WCD) that will provide the same fatty
      acid profile as the walnut diet, but will not contain walnuts (and their bioactives); and 3)
      a low ALA diet (LAD) with a similar macronutrient (and linoleic acid) composition as the WD
      and WCD, but using oleic acid to replace ALA. Study diets will be prepared in a metabolic
      kitchen, with three isocaloric meals and a snack provided each day, based on a 7-day rotating
      menu cycle. Participants will be instructed to consume only the prepared foods and limit
      their intake of alcohol to 2 drinks/week and caffeinated calorie-free beverages to 40 ounces
      (5 drinks) per day. Diets will be planned for every subject according to his/her energy
      requirements and will be nutritionally adequate. This diet design will permit the WD to be
      compared with the WCD and LAD and, thereby, allow us to ascertain the specific effects that
      walnuts and their bioactive components (including and beyond ALA) may have on CVD risk
      factors and artery health.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change from baseline in central blood pressure at the end of diet period 1 (week 6), end of diet period 2 (week 14), and end of diet period 3 (week 22)
time frame: End of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)
measure: Change in 24-hour ambulatory blood pressure
time frame: Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)
measure: Change in indices of arterial stiffness (pulse wave velocity)
time frame: Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)
measure: Change in lipoprotein particle size
time frame: Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)
description: The VAP© Test provides a direct measure of the following lipid and lipoprotein classes and subclasses: LDL, Lp(a), IDL, LDL1, LDL2, LDL3, LDL4, HDL, HDL2, HDL3, VLDL, VLDL1+2, VLDL3, TC, TG, Non-HDL, Remnant Lipoproteins, ApoB100, and ApoA1
measure: Change in inflammatory cytokines (tumor necrosis factor-alpha and interleukin-6)
time frame: Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)
measure: Change in the composition of the gut microbiome
time frame: Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)
description: This will be assessed via sequencing of microbial 16S rRNA from fecal samples.
measure: Change in serum C-reactive protein
time frame: Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)
measure: Change in serum glucose
time frame: Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)
measure: Change in serum insulin
time frame: Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)
measure: Change in urinary F2α-isoprostanes
time frame: Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)
measure: Change in lipid/lipoprotein profile
time frame: Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)
description: Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
measure: Change in heart rate variability
time frame: Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)
measure: Change in vascular adhesion markers (VCAM and ICAM)
time frame: Week 0, end of diet period 1 (week 6), end of diet period 2 (week 14), end of diet period 3 (week 22)
arm group label: Walnut Diet
arm group type: Experimental
description: Provides ~2 oz. walnuts/day (2-3% of total calories from alpha-linolenic acid [ALA])
arm group label: Walnut Control Diet
arm group type: Active Comparator
description: Provides same fatty acid profile (<7% SFA, 9% MUFA, 14-15% PUFA, 2-3% ALA) as Walnut Diet, but is devoid of walnuts and their bioactives
arm group label: Low ALA Diet
arm group type: Placebo Comparator
description: Provides similar macronutrient and linoleic acid profile but replaces ALA with oleic acid (<7% SFA, 12% MUFA, 12% PUFA, 0.5% ALA)
intervention type: Other
intervention name: Walnut Diet
description: 2 oz. walnuts/day (2-3% of total calories from ALA)
arm group label: Walnut Diet
intervention type: Other
intervention name: Walnut Control Diet
description: 2-3% ALA but no walnuts provided
arm group label: Walnut Control Diet
intervention type: Other
intervention name: Low ALA Diet
description: ALA replaced by oleic acid
arm group label: Low ALA Diet
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: McGuire S. U.S. Department of Agriculture and U.S. Department of Health and Human Services, Dietary Guidelines for Americans, 2010. 7th Edition, Washington, DC: U.S. Government Printing Office, January 2011. Adv Nutr. 2011 May;2(3):293-4. doi: 10.3945/an.111.000430. Epub 2011 Apr 30. No abstract available.
PMID: 22332062
citation: Sabate J, Fraser GE, Burke K, Knutsen SF, Bennett H, Lindsted KD. Effects of walnuts on serum lipid levels and blood pressure in normal men. N Engl J Med. 1993 Mar 4;328(9):603-7. doi: 10.1056/NEJM199303043280902.
PMID: 8357360
citation: Zhao G, Etherton TD, Martin KR, West SG, Gillies PJ, Kris-Etherton PM. Dietary alpha-linolenic acid reduces inflammatory and lipid cardiovascular risk factors in hypercholesterolemic men and women. J Nutr. 2004 Nov;134(11):2991-7. doi: 10.1093/jn/134.11.2991.
PMID: 15514264
citation: Banel DK, Hu FB. Effects of walnut consumption on blood lipids and other cardiovascular risk factors: a meta-analysis and systematic review. Am J Clin Nutr. 2009 Jul;90(1):56-63. doi: 10.3945/ajcn.2009.27457. Epub 2009 May 20.
PMID: 19458020
citation: West SG, Krick AL, Klein LC, Zhao G, Wojtowicz TF, McGuiness M, Bagshaw DM, Wagner P, Ceballos RM, Holub BJ, Kris-Etherton PM. Effects of diets high in walnuts and flax oil on hemodynamic responses to stress and vascular endothelial function. J Am Coll Nutr. 2010 Dec;29(6):595-603. doi: 10.1080/07315724.2010.10719898.
PMID: 21677123
citation: Estruch R, Ros E, Salas-Salvadó J, Covas MI, Corella D, Arós F, Gómez-Gracia E, Ruiz-Gutiérrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L,Pintó X, Basora J, Muñoz MA, Sorlí JV, Martínez JA, Martínez-González MA; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013;368:1279-1290.
citation: Zhang J, Grieger JA, Kris-Etherton PM, Thompson JT, Gillies PJ, Fleming JA, Vanden Heuvel JP. Walnut oil increases cholesterol efflux through inhibition of stearoyl CoA desaturase 1 in THP-1 macrophage-derived foam cells. Nutr Metab (Lond). 2011 Aug 26;8:61. doi: 10.1186/1743-7075-8-61.
PMID: 21871057
responsible party type: Sponsor
mesh term: Cardiovascular Diseases