<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/NCT02239198</url>
  </required_header>
  <id_info>
    <org_study_id>Nutrition Bar Trials</org_study_id>
    <secondary_id>CHORIbar</secondary_id>
    <nct_id>NCT02239198</nct_id>
  </id_info>
  <brief_title>Impact of a Nutritional Supplement on Metabolic Health</brief_title>
  <acronym>CHORIBar</acronym>
  <official_title>Attenuating the Micronutrient Malnutrition of Overnutrition (AMMO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UCSF Benioff Children's Hospital Oakland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>USDA Beltsville Human Nutrition Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>UCSF Benioff Children's Hospital Oakland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are prevalent micronutrient and fiber deficiencies in a significant proportion of US&#xD;
      population, particularly among the overweight or obese. Intensive lifestyle counseling&#xD;
      results in modest, measurable dietary improvements and weight stabilization, yet falls short&#xD;
      of restoring optimal nutritional status and metabolism. A carefully formulated nutritional&#xD;
      supplement bar (referred to as the CHORIBAR) delivered in a whole food matrix may correct&#xD;
      micronutrient deficiencies in overweight or obese adults and children. This may have a&#xD;
      beneficial impact on traditional indices of insulin dysregulation and the metabolic syndrome,&#xD;
      gut inflammation, redox status, immune function and DNA integrity, and may favorably&#xD;
      influence weight change and fat distribution.&#xD;
&#xD;
      The investigators believe that the improvements seen with CHORIBAR trials will be mediated at&#xD;
      the level of generalized enhancement in cellular metabolism that are not readily achieved&#xD;
      with lifestyle counseling alone. The investigators suspect this is due to many nutritional&#xD;
      barriers, some of which are disproportionately borne by inner city populations, such as cost&#xD;
      and access to healthy food. The investigators hypothesize that a nutritional supplement like&#xD;
      the CHORIBAR will facilitate restoration of optimal nutritional status and improve metabolic&#xD;
      and weight outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With our USDA partners, we have developed a whole-food, multi-component nutrient bars.&#xD;
      Previous pilot studies demonstrated that short-term bar consumption results in favorable&#xD;
      increases in HDL-cholesterol (HDL-c), particularly large-HDL (HDL-L) in most lean but only in&#xD;
      some overweight/obese individuals. Obesity is associated with poor gastrointestinal health&#xD;
      and systemic inflammation, which are also associated with low HDL. Our hypothesis is that a&#xD;
      carefully formulated nutritional supplement bar delivered in a whole food matrix can correct&#xD;
      micronutrient deficiencies in obese adults and have a beneficial impact on indices of insulin&#xD;
      dysregulation and the metabolic syndrome. The aims of this project are 1) to characterize the&#xD;
      effect size on indices of lipid profile, homocysteine, inflammation, insulin resistance,&#xD;
      micronutrient levels, DNA integrity, hunger and satiety, BMI, waist circumference, and blood&#xD;
      pressure with different formulations of CHORI bar taken twice daily for periods ranging from&#xD;
      2-8 weeks. We will also evaluate gut inflammation, redox status, tissue metals, and DNA&#xD;
      integrity with novel exploratory assays that may serve as markers for micronutrient&#xD;
      malnutrition and chronic disease risk. 2) Where significant improvement in the outcome&#xD;
      variables is observed, we will attempt to &quot;deconstruct&quot; the bars and attempt to determine the&#xD;
      active ingredients responsible for these changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 5, 2016</start_date>
  <completion_date type="Actual">April 13, 2017</completion_date>
  <primary_completion_date type="Actual">April 5, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>High density lipoprotein</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Cardiovascular Disease Prevention</condition>
  <arm_group>
    <arm_group_label>C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutrition bar without omega-3 fatty acids</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutrition bar without added minerals and vitamins</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Complete nutrition bar</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutrition bar</intervention_name>
    <description>The nutrition bar has been formulated to help achieve balanced nutrition with a polyphenolic-rich whole food matrix with vitamins, minerals, omega-3 fatty acids, and fiber at generally physiologic doses intended not to replace but to supplement a typical diet.</description>
    <arm_group_label>A</arm_group_label>
    <arm_group_label>B</arm_group_label>
    <arm_group_label>C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Either taking no dietary supplements or willing to discontinue any dietary supplements&#xD;
             for two weeks preceding the trial.&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  BMI &lt;40&#xD;
&#xD;
          -  Blood pressure &lt;140/90 mmHg, or stable blood pressure on medicines for past 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known diabetes mellitus according to the 2010 ADA criteria, but pre-diabetic subjects&#xD;
             with known impaired glucose tolerance (fasting glucose 101-125, and 2-hour&#xD;
             post-prandial glucose level 141-200 mg/dL) can remain eligible.&#xD;
&#xD;
          -  Weight loss pharmacotherapy.&#xD;
&#xD;
          -  Lipid-lowering medication as this will alter the lipid profile being measured.&#xD;
&#xD;
          -  Renal disease as this may affect blood pressure and dietary requirements.&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Pregnancy- a negative urine pregnancy test will be documented for any women&#xD;
             participants of childbearing age prior to enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruce Ames</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital &amp; Research Center at Oakland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ashutosh Lal, MD</last_name>
    <role>Study Director</role>
    <affiliation>Children's Hospital &amp; Research Center at Oakland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joyce McCann, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Children's Hospital &amp; Research Center at Oakland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michele Mietus-Snyder, MD</last_name>
    <role>Study Director</role>
    <affiliation>Children's Hospital &amp; Research Center at Oakland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital &amp; Research Center Oakland</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Mietus-Snyder ML, Shigenaga MK, Suh JH, Shenvi SV, Lal A, McHugh T, Olson D, Lilienstein J, Krauss RM, Gildengoren G, McCann JC, Ames BN. A nutrient-dense, high-fiber, fruit-based supplement bar increases HDL cholesterol, particularly large HDL, lowers homocysteine, and raises glutathione in a 2-wk trial. FASEB J. 2012 Aug;26(8):3515-27. doi: 10.1096/fj.11-201558. Epub 2012 May 1.</citation>
    <PMID>22549511</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>April 17, 2017</last_update_submitted>
  <last_update_submitted_qc>April 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HDL</keyword>
  <keyword>nutrition bar</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02239198
org study id: Nutrition Bar Trials
secondary id: CHORIbar
nct id: NCT02239198
lead sponsor: 
collaborator: 
has dmc: No
There are prevalent micronutrient and fiber deficiencies in a significant proportion of US
      population, particularly among the overweight or obese. Intensive lifestyle counseling
      results in modest, measurable dietary improvements and weight stabilization, yet falls short
      of restoring optimal nutritional status and metabolism. A carefully formulated nutritional
      supplement bar (referred to as the CHORIBAR) delivered in a whole food matrix may correct
      micronutrient deficiencies in overweight or obese adults and children. This may have a
      beneficial impact on traditional indices of insulin dysregulation and the metabolic syndrome,
      gut inflammation, redox status, immune function and DNA integrity, and may favorably
      influence weight change and fat distribution.

      The investigators believe that the improvements seen with CHORIBAR trials will be mediated at
      the level of generalized enhancement in cellular metabolism that are not readily achieved
      with lifestyle counseling alone. The investigators suspect this is due to many nutritional
      barriers, some of which are disproportionately borne by inner city populations, such as cost
      and access to healthy food. The investigators hypothesize that a nutritional supplement like
      the CHORIBAR will facilitate restoration of optimal nutritional status and improve metabolic
      and weight outcomes.
With our USDA partners, we have developed a whole-food, multi-component nutrient bars.
      Previous pilot studies demonstrated that short-term bar consumption results in favorable
      increases in HDL-cholesterol (HDL-c), particularly large-HDL (HDL-L) in most lean but only in
      some overweight/obese individuals. Obesity is associated with poor gastrointestinal health
      and systemic inflammation, which are also associated with low HDL. Our hypothesis is that a
      carefully formulated nutritional supplement bar delivered in a whole food matrix can correct
      micronutrient deficiencies in obese adults and have a beneficial impact on indices of insulin
      dysregulation and the metabolic syndrome. The aims of this project are 1) to characterize the
      effect size on indices of lipid profile, homocysteine, inflammation, insulin resistance,
      micronutrient levels, DNA integrity, hunger and satiety, BMI, waist circumference, and blood
      pressure with different formulations of CHORI bar taken twice daily for periods ranging from
      2-8 weeks. We will also evaluate gut inflammation, redox status, tissue metals, and DNA
      integrity with novel exploratory assays that may serve as markers for micronutrient
      malnutrition and chronic disease risk. 2) Where significant improvement in the outcome
      variables is observed, we will attempt to "deconstruct" the bars and attempt to determine the
      active ingredients responsible for these changes.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: High density lipoprotein
time frame: 1 year
arm group label: C
arm group type: Experimental
description: Nutrition bar without omega-3 fatty acids
arm group label: B
arm group type: Experimental
description: Nutrition bar without added minerals and vitamins
arm group label: A
arm group type: Active Comparator
description: Complete nutrition bar
intervention type: Other
intervention name: Nutrition bar
description: The nutrition bar has been formulated to help achieve balanced nutrition with a polyphenolic-rich whole food matrix with vitamins, minerals, omega-3 fatty acids, and fiber at generally physiologic doses intended not to replace but to supplement a typical diet.
arm group label: A
arm group label: B
arm group label: C
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bruce Ames
role: Principal Investigator
affiliation: Children's Hospital & Research Center at Oakland
last name: Ashutosh Lal, MD
role: Study Director
affiliation: Children's Hospital & Research Center at Oakland
last name: Joyce McCann, PhD
role: Study Director
affiliation: Children's Hospital & Research Center at Oakland
last name: Michele Mietus-Snyder, MD
role: Study Director
affiliation: Children's Hospital & Research Center at Oakland
facility: 
country: United States
citation: Mietus-Snyder ML, Shigenaga MK, Suh JH, Shenvi SV, Lal A, McHugh T, Olson D, Lilienstein J, Krauss RM, Gildengoren G, McCann JC, Ames BN. A nutrient-dense, high-fiber, fruit-based supplement bar increases HDL cholesterol, particularly large HDL, lowers homocysteine, and raises glutathione in a 2-wk trial. FASEB J. 2012 Aug;26(8):3515-27. doi: 10.1096/fj.11-201558. Epub 2012 May 1.
PMID: 22549511
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: No