<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/NCT02993458</url>
  </required_header>
  <id_info>
    <org_study_id>1U01HL128834-01A1</org_study_id>
    <secondary_id>1U01HL128834</secondary_id>
    <nct_id>NCT02993458</nct_id>
  </id_info>
  <brief_title>DASH-Sodium Trial in Adolescents</brief_title>
  <acronym>CampDASH</acronym>
  <official_title>DASH-Sodium Trial in Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Purdue University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Indiana University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Purdue University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Camp DASH study trial will compare the effect of two dietary patterns and two levels of&#xD;
      sodium intake on blood pressure and blood lipids in adolescents in the upper third of&#xD;
      distribution for blood pressure. The two dietary patterns are based on the Dietary Approaches&#xD;
      to Stop Hypertension (DASH) trial in adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Camp DASH study is a controlled trial. the aim of which is to compare the effect of two&#xD;
      dietary patterns and two levels of sodium intake on blood pressure and blood lipids in&#xD;
      adolescents in the upper third of distribution for blood pressure. The study also assesses&#xD;
      whether influences on blood pressure and blood lipids of dietary interventions vary according&#xD;
      to sex, race/ethnic groups, baseline levels, and other personal characteristics. The proposed&#xD;
      dietary interventions of DASH dietary patterns and sodium reduction have been shown to be&#xD;
      effective in lowering blood pressure in adults. The two dietary patterns are based on the&#xD;
      Dietary Approaches to Stop Hypertension (DASH) trial in adults. They are a Usual diet typical&#xD;
      of what many American adolescents eat, and a DASH-type diet. The DASH diet is rich in fruits,&#xD;
      vegetables, and low-fat dairy foods and low in saturated fat and total fat compared to the&#xD;
      Usual diet. The two sodium levels are High reflecting current US consumption and Low&#xD;
      reflecting current recommended intake levels. Weight will be held constant by adjusting&#xD;
      energy intake. The study participants will live in a residence hall on the Purdue campus&#xD;
      where all food and beverages will be provided, and meals and snacks will be supervised.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    safety risks to youth in the study required early termination of the study&#xD;
  </why_stopped>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">October 18, 2017</completion_date>
  <primary_completion_date type="Actual">October 18, 2017</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean systolic blood pressure (SBP)</measure>
    <time_frame>End of 25 day feeding intervention</time_frame>
    <description>The primary outcome is mean SBP at the end of each intervention feeding period. Mean end of intervention SBP is the average of daily readings during days 19-25 of each intervention feeding period. Blood pressure will also be measured periodically at baseline and throughout the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-HDL Cholesterol (HDLC)</measure>
    <time_frame>End of 25 day feeding intervention</time_frame>
    <description>Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure (DBP)</measure>
    <time_frame>End of 25 day feeding intervention</time_frame>
    <description>The secondary outcome is mean DBP at the end of each intervention feeding period. Mean end of intervention DBP is the average of daily readings during days 19-25 of each intervention feeding period. Blood pressure will also be measured periodically at baseline and throughout the study..</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>End of 25 day feeding intervention</time_frame>
    <description>Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-cholesterol</measure>
    <time_frame>End of 25 day feeding intervention</time_frame>
    <description>Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-cholesterol</measure>
    <time_frame>End of 25 day feeding intervention</time_frame>
    <description>Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol:HDLC ratio</measure>
    <time_frame>End of 25 day feeding intervention</time_frame>
    <description>Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>End of 25 day feeding intervention</time_frame>
    <description>Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary mineral excretion</measure>
    <time_frame>End of 25 day feeding intervention</time_frame>
    <description>Two 24-hr urine samples at the end of the feeding periods will be analyzed for sodium, potassium, magnesium, and calcium..</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regulators of sodium metabolism</measure>
    <time_frame>End of 25 day feeding intervention</time_frame>
    <description>Regulators of sodium homeostasis (renin, aldosterone, angiotensin) will be measured at the beginning and end of the feeding period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Augmentation index</measure>
    <time_frame>End of 25 day feeding intervention</time_frame>
    <description>Pulse wave analysis (At Cor Medical) will be used to measure changes in augmentation index (AI) with intervention to index central blood pressure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vasoreactivity</measure>
    <time_frame>End of 25 day feeding intervention</time_frame>
    <description>Skin flow motion (laser-doppler flowmetry) to measure diet-induced changes in vaso-reactivity will provide mechanistic information on microvascular control.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Blood High Pressure</condition>
  <arm_group>
    <arm_group_label>DASH diet-Low Na diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DASH style diet, low sodium (1500 mg/d).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DASH diet-High Na diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>DASH style diet, high sodium (3500 mg/d).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual diet-Low Na diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diet reflecting typical dietary pattern of American adolescents, low sodium (1500 mg/d).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual diet-High Na diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diet reflecting typical dietary pattern of American adolescents, high sodium (3500 mg/d).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DASH diet</intervention_name>
    <description>DASH style diet rich in fruits, vegetables, and low-fat dairy foods and low in saturated fat and total fat</description>
    <arm_group_label>DASH diet-High Na diet</arm_group_label>
    <arm_group_label>DASH diet-Low Na diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low Na diet</intervention_name>
    <description>Sodium intake of 1500 mg/d (65 mmol, or 0.75 mg/Kcal/d), representing the Adequate Intake recommended by the Institute of Medicine.</description>
    <arm_group_label>DASH diet-Low Na diet</arm_group_label>
    <arm_group_label>Usual diet-Low Na diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High Na diet</intervention_name>
    <description>Sodium intake of 3500 mg/d (152 mmol, or 1.73 mg/Kcal/d, representing the highest sodium intake used for adults in the DASH Sodium trial.</description>
    <arm_group_label>DASH diet-High Na diet</arm_group_label>
    <arm_group_label>Usual diet-High Na diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Diet</intervention_name>
    <description>The usual diet will include foods that provide the majority of energy for adolescents in the U.S., i.e. grain based desserts, pizza, sugary drinks,pasta, chicken, and chicken mixed dishes.</description>
    <arm_group_label>Usual diet-High Na diet</arm_group_label>
    <arm_group_label>Usual diet-Low Na diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  White, black, Hispanic, and Asian&#xD;
&#xD;
          -  SBP in the upper one-third of the distribution for their given sex, age, and height&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing lipid disorders, abnormal liver or kidney function&#xD;
&#xD;
          -  Taking medications that alter mineral absorption or metabolism, affect blood pressure&#xD;
             or lipids&#xD;
&#xD;
          -  If subjects are taking dietary supplements and refuse to discontinue them 2 months&#xD;
             prior to the study.&#xD;
&#xD;
          -  Taking non-prescription illegal drugs, smoke, or drink alcohol&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Carry an epi pen for food-related allergies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Connie M Weaver, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nutrition Science, Purdue University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Berdine R Martin, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Nutrition Science, Purdue University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Pediatrics, IU School of Medicine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Nutrition Science, Purdue University</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47907-2059</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997 Apr 17;336(16):1117-24. doi: 10.1056/NEJM199704173361601.</citation>
    <PMID>9099655</PMID>
  </reference>
  <reference>
    <citation>Berenson GS, Srinivasan SR, Bao W, Newman WP 3rd, Tracy RE, Wattigney WA. Association between multiple cardiovascular risk factors and atherosclerosis in children and young adults. The Bogalusa Heart Study. N Engl J Med. 1998 Jun 4;338(23):1650-6. doi: 10.1056/NEJM199806043382302.</citation>
    <PMID>9614255</PMID>
  </reference>
  <reference>
    <citation>Chen X, Wang Y. Tracking of blood pressure from childhood to adulthood: a systematic review and meta-regression analysis. Circulation. 2008 Jun 24;117(25):3171-80. doi: 10.1161/CIRCULATIONAHA.107.730366. Epub 2008 Jun 16.</citation>
    <PMID>18559702</PMID>
  </reference>
  <reference>
    <citation>Couch SC, Saelens BE, Levin L, Dart K, Falciglia G, Daniels SR. The efficacy of a clinic-based behavioral nutrition intervention emphasizing a DASH-type diet for adolescents with elevated blood pressure. J Pediatr. 2008 Apr;152(4):494-501. doi: 10.1016/j.jpeds.2007.09.022. Epub 2007 Nov 5.</citation>
    <PMID>18346503</PMID>
  </reference>
  <reference>
    <citation>Food and Nutrition Board, Institute of Medicine. 'Sodium and chloride', Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate. Washington, D.C.: National Academies Press; 2005. 269-423.</citation>
  </reference>
  <reference>
    <citation>Palacios C, Wigertz K, Martin BR, Braun M, Pratt JH, Peacock M, Weaver CM. Racial differences in potassium homeostasis in response to differences in dietary sodium in girls. Am J Clin Nutr. 2010 Mar;91(3):597-603. doi: 10.3945/ajcn.2009.28400. Epub 2009 Dec 9.</citation>
    <PMID>20007307</PMID>
  </reference>
  <reference>
    <citation>Palacios C, Wigertz K, Braun M, Martin BR, McCabe GP, McCabe L, Pratt JH, Peacock M, Weaver CM. Magnesium retention from metabolic-balance studies in female adolescents: impact of race, dietary salt, and calcium. Am J Clin Nutr. 2013 May;97(5):1014-9. doi: 10.3945/ajcn.112.039867. Epub 2013 Apr 3.</citation>
    <PMID>23553157</PMID>
  </reference>
  <reference>
    <citation>Palacios C, Wigertz K, Martin BR, Jackman L, Pratt JH, Peacock M, McCabe G, Weaver CM. Sodium retention in black and white female adolescents in response to salt intake. J Clin Endocrinol Metab. 2004 Apr;89(4):1858-63. doi: 10.1210/jc.2003-031446.</citation>
    <PMID>15070956</PMID>
  </reference>
  <reference>
    <citation>Rakova N, Juttner K, Dahlmann A, Schroder A, Linz P, Kopp C, Rauh M, Goller U, Beck L, Agureev A, Vassilieva G, Lenkova L, Johannes B, Wabel P, Moissl U, Vienken J, Gerzer R, Eckardt KU, Muller DN, Kirsch K, Morukov B, Luft FC, Titze J. Long-term space flight simulation reveals infradian rhythmicity in human Na(+) balance. Cell Metab. 2013 Jan 8;17(1):125-31. doi: 10.1016/j.cmet.2012.11.013.</citation>
    <PMID>23312287</PMID>
  </reference>
  <reference>
    <citation>Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER 3rd, Simons-Morton DG, Karanja N, Lin PH; DASH-Sodium Collaborative Research Group. Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. N Engl J Med. 2001 Jan 4;344(1):3-10. doi: 10.1056/NEJM200101043440101.</citation>
    <PMID>11136953</PMID>
  </reference>
  <reference>
    <citation>Van Horn L, Obarzanek E, Barton BA, Stevens VJ, Kwiterovich PO Jr, Lasser NL, Robson AM, Franklin FA Jr, Lauer RM, Kimm SY, Dorgan JF, Greenlick MR. A summary of results of the Dietary Intervention Study in Children (DISC): lessons learned. Prog Cardiovasc Nurs. 2003 Winter;18(1):28-41. doi: 10.1111/j.0889-7204.2003.01007.x.</citation>
    <PMID>12624570</PMID>
  </reference>
  <reference>
    <citation>Weaver CM, Martin BR, McCabe GP, McCabe LD, Woodward M, Anderson CA, Appel LJ. Individual variation in urinary sodium excretion among adolescent girls on a fixed intake. J Hypertens. 2016 Jul;34(7):1290-7. doi: 10.1097/HJH.0000000000000960.</citation>
    <PMID>27176144</PMID>
  </reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 6, 2017</last_update_submitted>
  <last_update_submitted_qc>December 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Purdue University</investigator_affiliation>
    <investigator_full_name>Berdine Martin</investigator_full_name>
    <investigator_title>Senior Research Scientist</investigator_title>
  </responsible_party>
  <keyword>dietary patterns</keyword>
  <keyword>blood pressure</keyword>
  <keyword>adolescents</keyword>
  <keyword>dietary sodium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02993458
org study id: 1U01HL128834-01A1
secondary id: 1U01HL128834
nct id: NCT02993458
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The Camp DASH study trial will compare the effect of two dietary patterns and two levels of
      sodium intake on blood pressure and blood lipids in adolescents in the upper third of
      distribution for blood pressure. The two dietary patterns are based on the Dietary Approaches
      to Stop Hypertension (DASH) trial in adults.
The Camp DASH study is a controlled trial. the aim of which is to compare the effect of two
      dietary patterns and two levels of sodium intake on blood pressure and blood lipids in
      adolescents in the upper third of distribution for blood pressure. The study also assesses
      whether influences on blood pressure and blood lipids of dietary interventions vary according
      to sex, race/ethnic groups, baseline levels, and other personal characteristics. The proposed
      dietary interventions of DASH dietary patterns and sodium reduction have been shown to be
      effective in lowering blood pressure in adults. The two dietary patterns are based on the
      Dietary Approaches to Stop Hypertension (DASH) trial in adults. They are a Usual diet typical
      of what many American adolescents eat, and a DASH-type diet. The DASH diet is rich in fruits,
      vegetables, and low-fat dairy foods and low in saturated fat and total fat compared to the
      Usual diet. The two sodium levels are High reflecting current US consumption and Low
      reflecting current recommended intake levels. Weight will be held constant by adjusting
      energy intake. The study participants will live in a residence hall on the Purdue campus
      where all food and beverages will be provided, and meals and snacks will be supervised.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Mean systolic blood pressure (SBP)
time frame: End of 25 day feeding intervention
description: The primary outcome is mean SBP at the end of each intervention feeding period. Mean end of intervention SBP is the average of daily readings during days 19-25 of each intervention feeding period. Blood pressure will also be measured periodically at baseline and throughout the study.
measure: Non-HDL Cholesterol (HDLC)
time frame: End of 25 day feeding intervention
description: Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period
measure: Diastolic blood pressure (DBP)
time frame: End of 25 day feeding intervention
description: The secondary outcome is mean DBP at the end of each intervention feeding period. Mean end of intervention DBP is the average of daily readings during days 19-25 of each intervention feeding period. Blood pressure will also be measured periodically at baseline and throughout the study..
measure: Total cholesterol
time frame: End of 25 day feeding intervention
description: Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period.
measure: HDL-cholesterol
time frame: End of 25 day feeding intervention
description: Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period
measure: LDL-cholesterol
time frame: End of 25 day feeding intervention
description: Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period
measure: Cholesterol:HDLC ratio
time frame: End of 25 day feeding intervention
description: Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period.
measure: Triglycerides
time frame: End of 25 day feeding intervention
description: Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period
measure: Urinary mineral excretion
time frame: End of 25 day feeding intervention
description: Two 24-hr urine samples at the end of the feeding periods will be analyzed for sodium, potassium, magnesium, and calcium..
measure: Regulators of sodium metabolism
time frame: End of 25 day feeding intervention
description: Regulators of sodium homeostasis (renin, aldosterone, angiotensin) will be measured at the beginning and end of the feeding period
measure: Augmentation index
time frame: End of 25 day feeding intervention
description: Pulse wave analysis (At Cor Medical) will be used to measure changes in augmentation index (AI) with intervention to index central blood pressure.
measure: Vasoreactivity
time frame: End of 25 day feeding intervention
description: Skin flow motion (laser-doppler flowmetry) to measure diet-induced changes in vaso-reactivity will provide mechanistic information on microvascular control.
arm group label: DASH diet-Low Na diet
arm group type: Experimental
description: DASH style diet, low sodium (1500 mg/d).
arm group label: DASH diet-High Na diet
arm group type: Active Comparator
description: DASH style diet, high sodium (3500 mg/d).
arm group label: Usual diet-Low Na diet
arm group type: Active Comparator
description: Diet reflecting typical dietary pattern of American adolescents, low sodium (1500 mg/d).
arm group label: Usual diet-High Na diet
arm group type: Active Comparator
description: Diet reflecting typical dietary pattern of American adolescents, high sodium (3500 mg/d).
intervention type: Other
intervention name: DASH diet
description: DASH style diet rich in fruits, vegetables, and low-fat dairy foods and low in saturated fat and total fat
arm group label: DASH diet-High Na diet
arm group label: DASH diet-Low Na diet
intervention type: Other
intervention name: Low Na diet
description: Sodium intake of 1500 mg/d (65 mmol, or 0.75 mg/Kcal/d), representing the Adequate Intake recommended by the Institute of Medicine.
arm group label: DASH diet-Low Na diet
arm group label: Usual diet-Low Na diet
intervention type: Other
intervention name: High Na diet
description: Sodium intake of 3500 mg/d (152 mmol, or 1.73 mg/Kcal/d, representing the highest sodium intake used for adults in the DASH Sodium trial.
arm group label: DASH diet-High Na diet
arm group label: Usual diet-High Na diet
intervention type: Other
intervention name: Usual Diet
description: The usual diet will include foods that provide the majority of energy for adolescents in the U.S., i.e. grain based desserts, pizza, sugary drinks,pasta, chicken, and chicken mixed dishes.
arm group label: Usual diet-High Na diet
arm group label: Usual diet-Low Na diet
criteria: 
gender: All
minimum age: 11 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Connie M Weaver, PhD
role: Principal Investigator
affiliation: Department of Nutrition Science, Purdue University
last name: Berdine R Martin, PhD
role: Study Director
affiliation: Department of Nutrition Science, Purdue University
facility: 
facility: 
country: United States
citation: Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997 Apr 17;336(16):1117-24. doi: 10.1056/NEJM199704173361601.
PMID: 9099655
citation: Berenson GS, Srinivasan SR, Bao W, Newman WP 3rd, Tracy RE, Wattigney WA. Association between multiple cardiovascular risk factors and atherosclerosis in children and young adults. The Bogalusa Heart Study. N Engl J Med. 1998 Jun 4;338(23):1650-6. doi: 10.1056/NEJM199806043382302.
PMID: 9614255
citation: Chen X, Wang Y. Tracking of blood pressure from childhood to adulthood: a systematic review and meta-regression analysis. Circulation. 2008 Jun 24;117(25):3171-80. doi: 10.1161/CIRCULATIONAHA.107.730366. Epub 2008 Jun 16.
PMID: 18559702
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responsible party type: Principal Investigator
investigator affiliation: Purdue University
investigator full name: Berdine Martin
investigator title: Senior Research Scientist
mesh term: Hypertension
sharing ipd: Undecided