<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/NCT02987049</url>
  </required_header>
  <id_info>
    <org_study_id>201611030</org_study_id>
    <nct_id>NCT02987049</nct_id>
  </id_info>
  <brief_title>Intensive Cardiac Rehabilitation (ICR): Tolerability and Effectiveness</brief_title>
  <official_title>Intensive Cardiac Rehabilitation (ICR) With the Pritikin Program: Tolerability and Effectiveness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to fill in the gaps in knowledge on the tolerability and&#xD;
      effectiveness of an outpatient, Pritikin-based Intensive Cardiac Rehabilitation (ICR) program&#xD;
      on traditional cardiovascular risk factors, exercise performance, and patient well-being (as&#xD;
      assessed by questionnaires), as well as to monitor subsequent clinical events. The hypothesis&#xD;
      is that patients in the Intensive Cardiac Rehabilitation (ICR) group will have greater&#xD;
      improvements in several cardiovascular disease risk factors than patients in the conventional&#xD;
      Cardiac Rehabilitation (CR) group at the end of 24 sessions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND: Conventional Cardiac Rehabilitation (CR) involves a 36-session supervised and&#xD;
      monitored exercise treatment program in a cardiac rehabilitation facility for patients with&#xD;
      an approved cardiac diagnosis, such as chronic angina, recent myocardial infarction (heart&#xD;
      attack), cardiac surgery, or recent percutaneous coronary intervention. The exercise sessions&#xD;
      generally are one hour each and the treatment period is typically over 12 weeks. Intensive&#xD;
      Cardiac Rehabilitation (ICR) includes the 36-session exercise intervention plus 36 one-hour&#xD;
      educational sessions on the Pritikin program. These education sessions include one-on-one&#xD;
      dietary consultation with a registered dietitian, nutrition workshops and cooking classes led&#xD;
      by a registered dietitian, a series of Pritikin videos, and a notebook of Pritikin handouts&#xD;
      on various topics, including reading nutrition labels, how to prepare heart-healthy meals,&#xD;
      mindfulness, smoking cessation, and the process of atherosclerosis.&#xD;
&#xD;
      Nathan Pritikin started the Pritikin program in the 1970s with the aim of decreasing&#xD;
      recurrent cardiovascular disease (CVD) events in humans. The three pillars of the Pritikin&#xD;
      lifestyle program are a healthy diet, exercise, and mindfulness. The Pritikin diet emphasizes&#xD;
      unprocessed foods that are high in fiber, low in calorie density, and very low in sodium,&#xD;
      saturated fat, and cholesterol. Mindfulness includes behavior modification therapies such as&#xD;
      smoking cessation and stress management. Since the 1970s, there have been more than 100&#xD;
      publications in scientific, peer-reviewed journals demonstrating the efficacy of this program&#xD;
      on improving many traditional cardiac risk factors and biomarkers of cardiac health, as well&#xD;
      as preventing and treating CVD. In addition, a low-fat, high fiber diet combined with&#xD;
      exercise has been shown to improve markers of nitric oxide bioavailability and fasting&#xD;
      insulin concentrations.&#xD;
&#xD;
      Most of these results, however, were derived from studies of patients domiciled at a Pritikin&#xD;
      wellness center. Relatively recently, the Pritikin program was approved as a form of ICR in&#xD;
      an outpatient setting. The BJC/Washington University School of Medicine Cardiac Rehab program&#xD;
      at the Heart Care Institute was the first Cardiac Rehab program in the world to offer an&#xD;
      outpatient Pritikin ICR program. Currently, Medicare and some (but not all) third-party&#xD;
      insurance companies pay for ICR. Thus, many patients under the age of 65 years are not&#xD;
      afforded the potential benefits of ICR.&#xD;
&#xD;
      SPECIFIC AIM: The purpose of this study is to fill in the gaps in knowledge on the&#xD;
      tolerability and effectiveness of an outpatient, Pritikin-based ICR program on traditional&#xD;
      cardiovascular risk factors, exercise performance, and patient well-being (as assessed by&#xD;
      questionnaires), as well as to monitor subsequent clinical events in this outpatient&#xD;
      population.&#xD;
&#xD;
      HYPOTHESIS: The hypothesis is that patients in the Intensive Cardiac Rehabilitation (ICR)&#xD;
      group will have greater improvements in several cardiovascular risk factors than patients in&#xD;
      the conventional Cardiac Rehab (CR) group at the end of 24 sessions.&#xD;
&#xD;
      FUTURE DIRECTIONS: If the results of this study are favorable, then there are several&#xD;
      implications for clinical practice. 1) Evidence of the effectiveness and tolerability of&#xD;
      outpatient ICR should encourage expanded coverage of ICR so that more cardiac patients may&#xD;
      benefit from this treatment in the future. 2) Demonstration of any trends in improvement of&#xD;
      outcomes would support the need for a multi-center trial to define the degree to which ICR&#xD;
      can help patients and decrease health care-related costs. These questions would be explored&#xD;
      in future R34 grants and Patient-Centered Outcomes Research Institute (PCORI) grants.&#xD;
&#xD;
      STUDY OVERVIEW: This is a 2-year, non-randomized study in which the Intensive Cardiac Rehab&#xD;
      (ICR) and conventional Cardiac Rehab (CR) treatment programs are already being conducted as&#xD;
      part of routine clinical care in a cardiac rehabilitation facility. Many of the assessments&#xD;
      to be conducted and the outcome measures of this study are being obtained as part of the&#xD;
      existing cardiac rehab programs. Assignment to the ICR or CR group will be according to the&#xD;
      referring physician's recommendation and insurance coverage and will occur before study&#xD;
      enrollment. The research portion is obtaining permission to include the participants'&#xD;
      phenotypic and outcome data in the research study database and analyzing the information in a&#xD;
      systematic manner to answer study questions regarding the tolerability and effectiveness of&#xD;
      the ICR program. Participants also will be asked to complete additional assessments and&#xD;
      questionnaires that are for research purposes only.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>Baseline and Vist 24, which occurs between 8 and 12 weeks</time_frame>
    <description>BMI will be computed from measured height and weight</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dietary Intake</measure>
    <time_frame>Baseline and Vist 24, which occurs between 8 and 12 weeks</time_frame>
    <description>Diet will be assessed using the Rate Your Plate questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>Baseline and Vist 24, which occurs between 8 and 12 weeks</time_frame>
    <description>% body fat, fat mass (kg), and fat-free mass (FFM) will be assessed by bioelectrical impedance analysis</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hand Grip Strength</measure>
    <time_frame>Baseline and Vist 24, which occurs between 8 and 12 weeks</time_frame>
    <description>Quantified with a Jamar Plus hand dynamometer</description>
  </other_outcome>
  <other_outcome>
    <measure>Short Physical Performance Battery (SPBB)</measure>
    <time_frame>Baseline and Vist 24, which occurs between 8 and 12 weeks</time_frame>
    <description>3 tests: 4m walk, balance, chair rise</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum Lipid Concentrations</measure>
    <time_frame>Baseline and Vist 24, which occurs between 8 and 12 weeks</time_frame>
    <description>Total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides</description>
  </other_outcome>
  <other_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>Baseline and Vist 24, which occurs between 8 and 12 weeks</time_frame>
    <description>quantified in whole blood</description>
  </other_outcome>
  <other_outcome>
    <measure>Resting Blood Pressure</measure>
    <time_frame>Baseline and Vist 24, which occurs between 8 and 12 weeks</time_frame>
    <description>systolic BP and diastolic BP (mmHg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Resting Heart Rate</measure>
    <time_frame>Baseline and Vist 24, which occurs between 8 and 12 weeks</time_frame>
    <description>bpm</description>
  </other_outcome>
  <other_outcome>
    <measure>Duke Activity Status Index (DASI) Questionnaire</measure>
    <time_frame>Baseline and Vist 24, which occurs between 8 and 12 weeks</time_frame>
    <description>Self-reported physical activity assessment</description>
  </other_outcome>
  <other_outcome>
    <measure>Dartmouth Coop General Health Questionnaire</measure>
    <time_frame>Baseline and Vist 24, which occurs between 8 and 12 weeks</time_frame>
    <description>Self-reported general health</description>
  </other_outcome>
  <other_outcome>
    <measure>Cardiac Self-Efficacy Questionnaire</measure>
    <time_frame>Baseline and Vist 24, which occurs between 8 and 12 weeks</time_frame>
    <description>Sullivan CSE</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>Baseline and Vist 24, which occurs between 8 and 12 weeks</time_frame>
    <description>Depression assessment</description>
  </other_outcome>
  <other_outcome>
    <measure>6-Minute Walk</measure>
    <time_frame>Baseline and Vist 24, which occurs between 8 and 12 weeks</time_frame>
    <description>Distance walked in 6 minutes</description>
  </other_outcome>
  <other_outcome>
    <measure>Arterial Function</measure>
    <time_frame>Baseline and Vist 24, which occurs between 8 and 12 weeks</time_frame>
    <description>Endothelial vasodilator function (i.e., arterial function) will be assessed using an EndoPat device</description>
  </other_outcome>
  <other_outcome>
    <measure>Medication Changes</measure>
    <time_frame>Baseline and Vist 24, which occurs between 8 and 12 weeks</time_frame>
    <description>Medication changes from Baseline to Visit 24</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Cardiac Disease</condition>
  <arm_group>
    <arm_group_label>ICR (Intensive Cardiac Rehab)</arm_group_label>
    <description>The Intensive Cardiac Rehabilitation (ICR) group will follow their physician-prescribed series of supervised exercise sessions and educational sessions in a cardiac rehab facility. The education component includes a series of Pritikin videos, nutrition workshops and cooking classes led by a registered dietitian, one-on-one dietary consultation with a registered dietitian, and a Pritikin notebook. The intervention for this study is comprised of 24 exercise sessions plus 24 educational sessions in 24 visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CR (conventional Cardiac Rehab)</arm_group_label>
    <description>The conventional Cardiac Rehabilitation (CR) group will follow their physician-prescribed series of supervised exercise sessions in the same cardiac rehab facility as the ICR group. The intervention for this study is comprised of 24 exercise sessions during 24 visits.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples will be obtained and the serum or plasma will be stored for future&#xD;
      quantification of inflammatory cytokines and other factors related to cardiovascular disease&#xD;
      risk.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female patients who are at least 18 years of age and are referred to the&#xD;
        BJC/Washington University School of Medicine Cardiac Rehab program at the Heart Care&#xD;
        Institute in St. Louis, MO will be invited to participate in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  individuals with a cardiac diagnosis or procedure who are referred to the BJC&#xD;
             HealthCare / Washington University School of Medicine Cardiac Rehab program at the&#xD;
             Heart Care Institute in St. Louis, Missouri&#xD;
&#xD;
          -  individuals who are ambulatory&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  individuals with other significant medical conditions that preclude exercise or that&#xD;
             would interfere with the assessments involved in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda R Peterson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <reference>
    <citation>Martin W. Nathan Pritikin and atheroma. Med Hypotheses. 1991 Nov;36(3):181-2. doi: 10.1016/0306-9877(91)90125-i. No abstract available.</citation>
    <PMID>1787805</PMID>
  </reference>
  <reference>
    <citation>Rosenthal MB, Barnard RJ, Rose DP, Inkeles S, Hall J, Pritikin N. Effects of a high-complex-carbohydrate, low-fat, low-cholesterol diet on levels of serum lipids and estradiol. Am J Med. 1985 Jan;78(1):23-7. doi: 10.1016/0002-9343(85)90456-5.</citation>
    <PMID>3966484</PMID>
  </reference>
  <reference>
    <citation>Roberts CK, Vaziri ND, Barnard RJ. Effect of diet and exercise intervention on blood pressure, insulin, oxidative stress, and nitric oxide availability. Circulation. 2002 Nov 12;106(20):2530-2. doi: 10.1161/01.cir.0000040584.91836.0d.</citation>
    <PMID>12427646</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>January 30, 2023</last_update_submitted>
  <last_update_submitted_qc>January 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heart disease, cardiac rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The current plan is that individual participant data will be shared with investigators on the research team only.</ipd_description>
  </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/NCT02987049
org study id: 201611030
nct id: NCT02987049
lead sponsor: 
has dmc: No
The purpose of this study is to fill in the gaps in knowledge on the tolerability and
      effectiveness of an outpatient, Pritikin-based Intensive Cardiac Rehabilitation (ICR) program
      on traditional cardiovascular risk factors, exercise performance, and patient well-being (as
      assessed by questionnaires), as well as to monitor subsequent clinical events. The hypothesis
      is that patients in the Intensive Cardiac Rehabilitation (ICR) group will have greater
      improvements in several cardiovascular disease risk factors than patients in the conventional
      Cardiac Rehabilitation (CR) group at the end of 24 sessions.
BACKGROUND: Conventional Cardiac Rehabilitation (CR) involves a 36-session supervised and
      monitored exercise treatment program in a cardiac rehabilitation facility for patients with
      an approved cardiac diagnosis, such as chronic angina, recent myocardial infarction (heart
      attack), cardiac surgery, or recent percutaneous coronary intervention. The exercise sessions
      generally are one hour each and the treatment period is typically over 12 weeks. Intensive
      Cardiac Rehabilitation (ICR) includes the 36-session exercise intervention plus 36 one-hour
      educational sessions on the Pritikin program. These education sessions include one-on-one
      dietary consultation with a registered dietitian, nutrition workshops and cooking classes led
      by a registered dietitian, a series of Pritikin videos, and a notebook of Pritikin handouts
      on various topics, including reading nutrition labels, how to prepare heart-healthy meals,
      mindfulness, smoking cessation, and the process of atherosclerosis.

      Nathan Pritikin started the Pritikin program in the 1970s with the aim of decreasing
      recurrent cardiovascular disease (CVD) events in humans. The three pillars of the Pritikin
      lifestyle program are a healthy diet, exercise, and mindfulness. The Pritikin diet emphasizes
      unprocessed foods that are high in fiber, low in calorie density, and very low in sodium,
      saturated fat, and cholesterol. Mindfulness includes behavior modification therapies such as
      smoking cessation and stress management. Since the 1970s, there have been more than 100
      publications in scientific, peer-reviewed journals demonstrating the efficacy of this program
      on improving many traditional cardiac risk factors and biomarkers of cardiac health, as well
      as preventing and treating CVD. In addition, a low-fat, high fiber diet combined with
      exercise has been shown to improve markers of nitric oxide bioavailability and fasting
      insulin concentrations.

      Most of these results, however, were derived from studies of patients domiciled at a Pritikin
      wellness center. Relatively recently, the Pritikin program was approved as a form of ICR in
      an outpatient setting. The BJC/Washington University School of Medicine Cardiac Rehab program
      at the Heart Care Institute was the first Cardiac Rehab program in the world to offer an
      outpatient Pritikin ICR program. Currently, Medicare and some (but not all) third-party
      insurance companies pay for ICR. Thus, many patients under the age of 65 years are not
      afforded the potential benefits of ICR.

      SPECIFIC AIM: The purpose of this study is to fill in the gaps in knowledge on the
      tolerability and effectiveness of an outpatient, Pritikin-based ICR program on traditional
      cardiovascular risk factors, exercise performance, and patient well-being (as assessed by
      questionnaires), as well as to monitor subsequent clinical events in this outpatient
      population.

      HYPOTHESIS: The hypothesis is that patients in the Intensive Cardiac Rehabilitation (ICR)
      group will have greater improvements in several cardiovascular risk factors than patients in
      the conventional Cardiac Rehab (CR) group at the end of 24 sessions.

      FUTURE DIRECTIONS: If the results of this study are favorable, then there are several
      implications for clinical practice. 1) Evidence of the effectiveness and tolerability of
      outpatient ICR should encourage expanded coverage of ICR so that more cardiac patients may
      benefit from this treatment in the future. 2) Demonstration of any trends in improvement of
      outcomes would support the need for a multi-center trial to define the degree to which ICR
      can help patients and decrease health care-related costs. These questions would be explored
      in future R34 grants and Patient-Centered Outcomes Research Institute (PCORI) grants.

      STUDY OVERVIEW: This is a 2-year, non-randomized study in which the Intensive Cardiac Rehab
      (ICR) and conventional Cardiac Rehab (CR) treatment programs are already being conducted as
      part of routine clinical care in a cardiac rehabilitation facility. Many of the assessments
      to be conducted and the outcome measures of this study are being obtained as part of the
      existing cardiac rehab programs. Assignment to the ICR or CR group will be according to the
      referring physician's recommendation and insurance coverage and will occur before study
      enrollment. The research portion is obtaining permission to include the participants'
      phenotypic and outcome data in the research study database and analyzing the information in a
      systematic manner to answer study questions regarding the tolerability and effectiveness of
      the ICR program. Participants also will be asked to complete additional assessments and
      questionnaires that are for research purposes only.
observational model: Cohort
time perspective: Prospective
measure: Body Mass Index (BMI)
time frame: Baseline and Vist 24, which occurs between 8 and 12 weeks
description: BMI will be computed from measured height and weight
measure: Dietary Intake
time frame: Baseline and Vist 24, which occurs between 8 and 12 weeks
description: Diet will be assessed using the Rate Your Plate questionnaire
measure: Body Composition
time frame: Baseline and Vist 24, which occurs between 8 and 12 weeks
description: % body fat, fat mass (kg), and fat-free mass (FFM) will be assessed by bioelectrical impedance analysis
measure: Hand Grip Strength
time frame: Baseline and Vist 24, which occurs between 8 and 12 weeks
description: Quantified with a Jamar Plus hand dynamometer
measure: Short Physical Performance Battery (SPBB)
time frame: Baseline and Vist 24, which occurs between 8 and 12 weeks
description: 3 tests: 4m walk, balance, chair rise
measure: Serum Lipid Concentrations
time frame: Baseline and Vist 24, which occurs between 8 and 12 weeks
description: Total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides
measure: Hemoglobin A1c
time frame: Baseline and Vist 24, which occurs between 8 and 12 weeks
description: quantified in whole blood
measure: Resting Blood Pressure
time frame: Baseline and Vist 24, which occurs between 8 and 12 weeks
description: systolic BP and diastolic BP (mmHg)
measure: Resting Heart Rate
time frame: Baseline and Vist 24, which occurs between 8 and 12 weeks
description: bpm
measure: Duke Activity Status Index (DASI) Questionnaire
time frame: Baseline and Vist 24, which occurs between 8 and 12 weeks
description: Self-reported physical activity assessment
measure: Dartmouth Coop General Health Questionnaire
time frame: Baseline and Vist 24, which occurs between 8 and 12 weeks
description: Self-reported general health
measure: Cardiac Self-Efficacy Questionnaire
time frame: Baseline and Vist 24, which occurs between 8 and 12 weeks
description: Sullivan CSE
measure: Patient Health Questionnaire-9 (PHQ-9)
time frame: Baseline and Vist 24, which occurs between 8 and 12 weeks
description: Depression assessment
measure: 6-Minute Walk
time frame: Baseline and Vist 24, which occurs between 8 and 12 weeks
description: Distance walked in 6 minutes
measure: Arterial Function
time frame: Baseline and Vist 24, which occurs between 8 and 12 weeks
description: Endothelial vasodilator function (i.e., arterial function) will be assessed using an EndoPat device
measure: Medication Changes
time frame: Baseline and Vist 24, which occurs between 8 and 12 weeks
description: Medication changes from Baseline to Visit 24
arm group label: ICR (Intensive Cardiac Rehab)
description: The Intensive Cardiac Rehabilitation (ICR) group will follow their physician-prescribed series of supervised exercise sessions and educational sessions in a cardiac rehab facility. The education component includes a series of Pritikin videos, nutrition workshops and cooking classes led by a registered dietitian, one-on-one dietary consultation with a registered dietitian, and a Pritikin notebook. The intervention for this study is comprised of 24 exercise sessions plus 24 educational sessions in 24 visits.
arm group label: CR (conventional Cardiac Rehab)
description: The conventional Cardiac Rehabilitation (CR) group will follow their physician-prescribed series of supervised exercise sessions in the same cardiac rehab facility as the ICR group. The intervention for this study is comprised of 24 exercise sessions during 24 visits.
Blood samples will be obtained and the serum or plasma will be stored for future
      quantification of inflammatory cytokines and other factors related to cardiovascular disease
      risk.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Linda R Peterson, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
citation: Martin W. Nathan Pritikin and atheroma. Med Hypotheses. 1991 Nov;36(3):181-2. doi: 10.1016/0306-9877(91)90125-i. No abstract available.
PMID: 1787805
citation: Rosenthal MB, Barnard RJ, Rose DP, Inkeles S, Hall J, Pritikin N. Effects of a high-complex-carbohydrate, low-fat, low-cholesterol diet on levels of serum lipids and estradiol. Am J Med. 1985 Jan;78(1):23-7. doi: 10.1016/0002-9343(85)90456-5.
PMID: 3966484
citation: Roberts CK, Vaziri ND, Barnard RJ. Effect of diet and exercise intervention on blood pressure, insulin, oxidative stress, and nitric oxide availability. Circulation. 2002 Nov 12;106(20):2530-2. doi: 10.1161/01.cir.0000040584.91836.0d.
PMID: 12427646
responsible party type: Sponsor
mesh term: Heart Diseases
sharing ipd: Undecided
ipd description: The current plan is that individual participant data will be shared with investigators on the research team only.