<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/NCT02977039</url>
  </required_header>
  <id_info>
    <org_study_id>2016P000321</org_study_id>
    <nct_id>NCT02977039</nct_id>
  </id_info>
  <brief_title>Effect of a Plant Rich Diet on in People With Type 2 Diabetes and Obesity</brief_title>
  <official_title>Effect of a Nutrient Dense Plant Rich Diet on Glycemic Control in People With Type 2 Diabetes and Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of a nutrient dense plant rich (NDPR)&#xD;
      diet compared to a standard USDA diet on glycemic control, inflammation, and cardiovascular&#xD;
      risk in individuals with type 2 diabetes and overweight/obesity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 2019</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>change at 1, 3, 6, 9, 12 months</time_frame>
    <description>A1C and finger stick blood sugar levels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>body weight</measure>
    <time_frame>change at 1, 3, 6, 9, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body composition</measure>
    <time_frame>change at 1,3,6,9, 12 months</time_frame>
    <description>DXA scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hepatic steatosis</measure>
    <time_frame>baseline, 1, 3, 6, 9, 12 months</time_frame>
    <description>MRspectroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory markers</measure>
    <time_frame>change at, 1, 3, 6, 9, 12 months</time_frame>
    <description>serum inflammatory markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>change at, 1, 3, 6, 9, 12 months</time_frame>
    <description>validated questionnaired</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Type 2 Diabetes Mellitus in Obese</condition>
  <arm_group>
    <arm_group_label>NDPR diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to the nutrient dense plant rich (NDPR) diet will eat foods with high micronutrient density, and favorable glycemic index. The diet is low in saturated fat, high in fiber, and rich in phytochemicals. Total caloric intake will range from 1600-2000/day based on individual needs. Foods include vegetables (30-70% of calories), fruits (15-20% of calories), Beans/Legumes (20-30% of calories), raw nuts and seeds (10-20% of calories), fish or fat-free dairy (twice weekly or less), poultry, eggs and oils (once weekly or less) and limited beef, cheese/milk, processed food and beef.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>USDA diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to the healthy U.S.-Style pattern diet will eat the types and proportions of foods Americans typically consume, but in nutrient-dense forms and appropriate amounts. It is designed to meet nutrient needs while not exceeding calorie requirements and while staying within limits for overconsumed dietary components. Total caloric intake will range from 1600-2000/day based on individual needs. Foods include fruits, vegetables (dark green, red/orange, beans, and peas, starchy vegetables), grains (whole grains and refined grains), protein foods (meat, poultry, eggs, seafood, nuts, seeds and soy products), dairy, and oils.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NDPR diet</intervention_name>
    <description>nutrient rich plant based diert</description>
    <arm_group_label>NDPR diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>USDA healthy eating diet</intervention_name>
    <description>DASH diet</description>
    <arm_group_label>USDA diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women ages 18-75&#xD;
&#xD;
          2. Type 2 diabetes mellitus diagnosed &gt; 6 months prior to screening visit according to&#xD;
             American Diabetes Association criteria&#xD;
&#xD;
          3. HBA1c &gt;7.5% but &lt; 10%&#xD;
&#xD;
          4. BMI &gt;25 kg/m2 ; &gt;23 kg/m2 for Asian subjects but &lt; 45 kg/m2&#xD;
&#xD;
          5. Stable weight (variation &lt; 5 kg within 6 months of screening visit)&#xD;
&#xD;
          6. Ability to give informed consent&#xD;
&#xD;
          7. Ability to follow verbal and written instructions in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active cardiac issues: history of myocardial infarction within 3 months of screening&#xD;
             visit, unstable angina pectoris, or Class III or Class IV congestive heart failure&#xD;
&#xD;
          2. Persistent uncontrolled hypertension (BP &gt; 160/100 mmHg on or off antihypertensive&#xD;
             medication)&#xD;
&#xD;
          3. Active marijuana or intravenous drug use&#xD;
&#xD;
          4. Recent weight loss (&gt; 5 kg within 6 months of the screening visit)&#xD;
&#xD;
          5. Inflammatory or irritable bowel disease (Crohn's Disease, Ulcerative Colitis, or IBS)&#xD;
&#xD;
          6. Celiac disease&#xD;
&#xD;
          7. Malignancy treated with chemotherapy within the past 1 year&#xD;
&#xD;
          8. Depression or psychosis requiring hospitalization within 1 year, or use of major&#xD;
             antipsychotic or tranquilizer drugs (i.e. benzodiazepines)&#xD;
&#xD;
          9. Renal insufficiency (creatinine clearance &lt; 30 ml/min)&#xD;
&#xD;
         10. Transaminases &gt; 2x above the normal range&#xD;
&#xD;
         11. Pregnancy within 6 months of the screening visit&#xD;
&#xD;
         12. Lactation&#xD;
&#xD;
         13. History of surgery for the treatment of obesity (gastric banding, gastric bypass,&#xD;
             gastric stapling&#xD;
&#xD;
         14. History of alcohol abuse within the past 5 years&#xD;
&#xD;
         15. Vegetarian/Vegan diet&#xD;
&#xD;
         16. Dairy Allergy/Intolerance&#xD;
&#xD;
         17. Anemia, including iron deficient and megaloblastic&#xD;
&#xD;
         18. Vitamin B12 deficiency&#xD;
&#xD;
         19. Leber's disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>January 13, 2020</last_update_submitted>
  <last_update_submitted_qc>January 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Martin Abrahamson</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will not share individual participant data with other researchers</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/NCT02977039
org study id: 2016P000321
nct id: NCT02977039
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effect of a nutrient dense plant rich (NDPR)
      diet compared to a standard USDA diet on glycemic control, inflammation, and cardiovascular
      risk in individuals with type 2 diabetes and overweight/obesity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Glycemic control
time frame: change at 1, 3, 6, 9, 12 months
description: A1C and finger stick blood sugar levels
measure: body weight
time frame: change at 1, 3, 6, 9, 12 months
measure: body composition
time frame: change at 1,3,6,9, 12 months
description: DXA scan
measure: hepatic steatosis
time frame: baseline, 1, 3, 6, 9, 12 months
description: MRspectroscopy
measure: inflammatory markers
time frame: change at, 1, 3, 6, 9, 12 months
description: serum inflammatory markers
measure: quality of life
time frame: change at, 1, 3, 6, 9, 12 months
description: validated questionnaired
arm group label: NDPR diet
arm group type: Experimental
description: Subjects randomized to the nutrient dense plant rich (NDPR) diet will eat foods with high micronutrient density, and favorable glycemic index. The diet is low in saturated fat, high in fiber, and rich in phytochemicals. Total caloric intake will range from 1600-2000/day based on individual needs. Foods include vegetables (30-70% of calories), fruits (15-20% of calories), Beans/Legumes (20-30% of calories), raw nuts and seeds (10-20% of calories), fish or fat-free dairy (twice weekly or less), poultry, eggs and oils (once weekly or less) and limited beef, cheese/milk, processed food and beef.
arm group label: USDA diet
arm group type: Experimental
description: Subjects randomized to the healthy U.S.-Style pattern diet will eat the types and proportions of foods Americans typically consume, but in nutrient-dense forms and appropriate amounts. It is designed to meet nutrient needs while not exceeding calorie requirements and while staying within limits for overconsumed dietary components. Total caloric intake will range from 1600-2000/day based on individual needs. Foods include fruits, vegetables (dark green, red/orange, beans, and peas, starchy vegetables), grains (whole grains and refined grains), protein foods (meat, poultry, eggs, seafood, nuts, seeds and soy products), dairy, and oils.
intervention type: Other
intervention name: NDPR diet
description: nutrient rich plant based diert
arm group label: NDPR diet
intervention type: Other
intervention name: USDA healthy eating diet
description: DASH diet
arm group label: USDA diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Martin Abrahamson
investigator title: Principal Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
ipd description: We will not share individual participant data with other researchers