<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/NCT02214173</url>
  </required_header>
  <id_info>
    <org_study_id>20130279</org_study_id>
    <nct_id>NCT02214173</nct_id>
  </id_info>
  <brief_title>The Effect of an Enhanced Rice Bran Nutritional Supplement in HIV</brief_title>
  <acronym>BRM4</acronym>
  <official_title>The Effect of an Enhanced Rice Bran Nutritional Supplement on Metabolic Syndrome Variables in HIV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Daiwa Health Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effects of the nutritional supplement rice&#xD;
      bran arabinoxylan compound (RBAC) on metabolic syndrome variables in persons living with HIV.&#xD;
      The hypothesis is that there will be a significant improvement in metabolic syndrome and&#xD;
      immune variables in HIV-positive participants in the intervention group compared to the&#xD;
      control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to investigate the effects of Rice Bran Arabinoxylan Compound&#xD;
      (RBAC) on metabolic syndrome variables in persons living with HIV (PLWH). This nutritional&#xD;
      supplement is made from a water soluble extract of rice bran that has been partially&#xD;
      hydrolyzed by the action of a natural enzyme complex extracted from Shiitake mushroom. Given&#xD;
      that these micronutrients may be important for regulating the immune system and metabolizing&#xD;
      glucose, the investigators will explore the impact of RBAC on metabolic syndrome (MetSyn)&#xD;
      variables according to the National Cholesterol Education Program (NCEP) Adult Treatment&#xD;
      Panel III guidelines (1) (fasting plasma glucose, waist circumference, high-density&#xD;
      lipoprotein [HDL] cholesterol, triglycerides, and blood pressure), secondarily on additional&#xD;
      atherogenic variables (total cholesterol, low-density lipoprotein [LDL] cholesterol, hip&#xD;
      circumference, and body mass index) and immune functioning (CD4+ and CD8+) among 40 HIV+&#xD;
      adult (18+ years of age and over) patients on stable antiretroviral therapy (ART).&#xD;
      Specifically, subjects will participate in a 6-month, two-group, randomized intervention,&#xD;
      where one group (n=20) will take 3 gram/day RBAC and the other group (n=20) will take a&#xD;
      placebo to compare differences in outcomes between the two groups. The results of the study&#xD;
      are intended to address the multi-faceted physiological problems of HIV+ patients by testing&#xD;
      the efficacy of a nutritional supplement intervention on multiple outcomes in this&#xD;
      population.&#xD;
&#xD;
      No substantial psychological, medical, or social risks exist to the participants, other than&#xD;
      minor discomfort associated with the venipuncture. Although all measures to protect&#xD;
      confidentiality will be put in place, the possibility exists that electronic data could be&#xD;
      jeopardized. In the remote case that such event occurs, it will be immediately reported to&#xD;
      the Institutional Review Board.&#xD;
&#xD;
      The components of RBAC should be harmless without significant food allergies. No serious,&#xD;
      untoward side effects have been reported to the company by consumers nor observed during&#xD;
      previous human studies. Potential adverse effects will be explained to each participant when&#xD;
      informed consent is obtained. Whole foods supplements are virtually no different than&#xD;
      consuming food, because of how they are manufactured. The investigators prior study on RBAC&#xD;
      showed no adverse effects. If any side effect does occur, the remedy is to discontinue until&#xD;
      asymptomatic, and then reintroduce at 1/4 dosage, increasing by the same amount every 2 days,&#xD;
      if uneventful, until full dosage is achieved. Study staff will provide additional follow-up&#xD;
      and consultation with any subject who experiences an untoward side effect.&#xD;
&#xD;
      Other potential risks include:&#xD;
&#xD;
        1. Randomization. A potential risk for the placebo group is no improvement in the&#xD;
           investigators outcomes of interest.&#xD;
&#xD;
        2. Data collection. The investigators foresee minimal risks associated with the testing,&#xD;
           other than discomfort or fatigue.&#xD;
&#xD;
      A toxicology search for each component reveals no unique toxicity characteristic of the&#xD;
      materials. As reported by Daiwa Health Development, the manufacturer of the product,&#xD;
      thousands of people currently use RBAC (under the trade names BRM4 and PeakImmune 4), and&#xD;
      Daiwa is unaware of significant toxicities. Daiwa applies the latest scientific methods to&#xD;
      ensure the value and safety of their raw materials. Daiwa products are manufactured in&#xD;
      state-of-the-art facilities, under strict quality control and environmental protection&#xD;
      standards.&#xD;
&#xD;
      Participants will incur no additional appreciable psychological or social risks by&#xD;
      participating in this study, although they may undergo psychological and physical discomfort&#xD;
      sometimes. The process of interviewing during the assessment may cause discomfort. Discomfort&#xD;
      or fatigue may also be experienced in completing the assessment battery.&#xD;
&#xD;
      Alternatives to this study for these MetSyn and immune functioning variables include&#xD;
      prescription medications, exercise, dietary modification, and other nutritional supplements.&#xD;
      The risks of medications can be very significant, including life-threatening, but the risk of&#xD;
      taking nutritional supplements is not totally understood, since they are not regulated by the&#xD;
      US Food and Drug Administration. Medications and nutritional supplements, as part of a change&#xD;
      in lifestyle behaviors, may also prove to be beneficial for MetSyn variables and immune&#xD;
      system functioning, but their long-term use has unknown consequences.&#xD;
&#xD;
      The information obtained in this study will help in determining the efficacy of using RBAC on&#xD;
      MetSyn and metabolic variables and immune system functioning. By participating in the study,&#xD;
      subjects may experience improved health status. The risk of participating in this study is&#xD;
      reasonable because of the potential enhancements in metabolic and immune system functioning&#xD;
      with improved nutritional status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Metabolic Syndrome Markers</measure>
    <time_frame>3 months and 6 months</time_frame>
    <description>Improvement in glucose, lipid profile, blood pressure, cluster of differentiation 4 (CD4), and cluster of differentiation 8 (CD8) values.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Human Immunodeficiency Virus Infection</condition>
  <arm_group>
    <arm_group_label>rice bran arabinoxylan compound (RBAC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>rice bran arabinoxylan compound (RBAC)</intervention_name>
    <description>2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.</description>
    <arm_group_label>rice bran arabinoxylan compound (RBAC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 or older&#xD;
&#xD;
          2. Confirmed HIV infection&#xD;
&#xD;
          3. CD4 T cell counts &gt; 50/µl and &lt; 250/µl&#xD;
&#xD;
          4. On a stable ART regimen (e.g., Kaletra-based) before (≤6 months) and during the&#xD;
             intervention&#xD;
&#xD;
          5. Planning to maintain current medication during the course of the intervention&#xD;
&#xD;
          6. Not on any lipid-lowering agents for a minimum of 3 months before the enrollment&#xD;
&#xD;
          7. Previous nutritional supplement usage of similar polysaccharide formula permitted, but&#xD;
             current use must be stopped 2 weeks before and during trial&#xD;
&#xD;
          8. Interested in participating in a dietary supplement study&#xD;
&#xD;
          9. Willing to follow recommendations for participating in the study&#xD;
&#xD;
         10. Willing to not consume food, alcohol, caffeine, or stimulants (amphetamines) 12 hours&#xD;
             before each assessment&#xD;
&#xD;
         11. Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently enrolled in another research trial for similar investigative nutritional&#xD;
             therapies&#xD;
&#xD;
          2. Known allergy to rice, rice bran, mushrooms, or related food products&#xD;
&#xD;
          3. Any gastrointestinal disorders that could lead to uncertain resorption of the study&#xD;
             supplement&#xD;
&#xD;
          4. Other medical complications that might preclude one from participating in the study,&#xD;
             i.e., recent heart attack or stroke or chronic kidney disease&#xD;
&#xD;
          5. Currently taking immunomodulatory medication, i.e., interferon&#xD;
&#xD;
          6. Currently taking chemotherapeutic agents&#xD;
&#xD;
          7. Multiple drug resistance&#xD;
&#xD;
          8. Current smoker&#xD;
&#xD;
          9. Severe anemia or other medical condition that will not permit a safe blood draw&#xD;
&#xD;
         10. A bleeding disorder&#xD;
&#xD;
         11. A terminal illness&#xD;
&#xD;
         12. Women who are pregnant or are attempting conception, especially in the presence of a&#xD;
             history of recurrent spontaneous abortion&#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>John E Lewis, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine, Clinical Research Building, Department of Psychiatry &amp; Behavioral Sciences</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>July 15, 2016</last_update_submitted>
  <last_update_submitted_qc>July 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>John E. Lewis</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>HIV, BRM4, hydrolyzed rice bran, metabolic syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</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/NCT02214173
org study id: 20130279
nct id: NCT02214173
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate the effects of the nutritional supplement rice
      bran arabinoxylan compound (RBAC) on metabolic syndrome variables in persons living with HIV.
      The hypothesis is that there will be a significant improvement in metabolic syndrome and
      immune variables in HIV-positive participants in the intervention group compared to the
      control group.
The purpose of this study is to investigate the effects of Rice Bran Arabinoxylan Compound
      (RBAC) on metabolic syndrome variables in persons living with HIV (PLWH). This nutritional
      supplement is made from a water soluble extract of rice bran that has been partially
      hydrolyzed by the action of a natural enzyme complex extracted from Shiitake mushroom. Given
      that these micronutrients may be important for regulating the immune system and metabolizing
      glucose, the investigators will explore the impact of RBAC on metabolic syndrome (MetSyn)
      variables according to the National Cholesterol Education Program (NCEP) Adult Treatment
      Panel III guidelines (1) (fasting plasma glucose, waist circumference, high-density
      lipoprotein [HDL] cholesterol, triglycerides, and blood pressure), secondarily on additional
      atherogenic variables (total cholesterol, low-density lipoprotein [LDL] cholesterol, hip
      circumference, and body mass index) and immune functioning (CD4+ and CD8+) among 40 HIV+
      adult (18+ years of age and over) patients on stable antiretroviral therapy (ART).
      Specifically, subjects will participate in a 6-month, two-group, randomized intervention,
      where one group (n=20) will take 3 gram/day RBAC and the other group (n=20) will take a
      placebo to compare differences in outcomes between the two groups. The results of the study
      are intended to address the multi-faceted physiological problems of HIV+ patients by testing
      the efficacy of a nutritional supplement intervention on multiple outcomes in this
      population.

      No substantial psychological, medical, or social risks exist to the participants, other than
      minor discomfort associated with the venipuncture. Although all measures to protect
      confidentiality will be put in place, the possibility exists that electronic data could be
      jeopardized. In the remote case that such event occurs, it will be immediately reported to
      the Institutional Review Board.

      The components of RBAC should be harmless without significant food allergies. No serious,
      untoward side effects have been reported to the company by consumers nor observed during
      previous human studies. Potential adverse effects will be explained to each participant when
      informed consent is obtained. Whole foods supplements are virtually no different than
      consuming food, because of how they are manufactured. The investigators prior study on RBAC
      showed no adverse effects. If any side effect does occur, the remedy is to discontinue until
      asymptomatic, and then reintroduce at 1/4 dosage, increasing by the same amount every 2 days,
      if uneventful, until full dosage is achieved. Study staff will provide additional follow-up
      and consultation with any subject who experiences an untoward side effect.

      Other potential risks include:

        1. Randomization. A potential risk for the placebo group is no improvement in the
           investigators outcomes of interest.

        2. Data collection. The investigators foresee minimal risks associated with the testing,
           other than discomfort or fatigue.

      A toxicology search for each component reveals no unique toxicity characteristic of the
      materials. As reported by Daiwa Health Development, the manufacturer of the product,
      thousands of people currently use RBAC (under the trade names BRM4 and PeakImmune 4), and
      Daiwa is unaware of significant toxicities. Daiwa applies the latest scientific methods to
      ensure the value and safety of their raw materials. Daiwa products are manufactured in
      state-of-the-art facilities, under strict quality control and environmental protection
      standards.

      Participants will incur no additional appreciable psychological or social risks by
      participating in this study, although they may undergo psychological and physical discomfort
      sometimes. The process of interviewing during the assessment may cause discomfort. Discomfort
      or fatigue may also be experienced in completing the assessment battery.

      Alternatives to this study for these MetSyn and immune functioning variables include
      prescription medications, exercise, dietary modification, and other nutritional supplements.
      The risks of medications can be very significant, including life-threatening, but the risk of
      taking nutritional supplements is not totally understood, since they are not regulated by the
      US Food and Drug Administration. Medications and nutritional supplements, as part of a change
      in lifestyle behaviors, may also prove to be beneficial for MetSyn variables and immune
      system functioning, but their long-term use has unknown consequences.

      The information obtained in this study will help in determining the efficacy of using RBAC on
      MetSyn and metabolic variables and immune system functioning. By participating in the study,
      subjects may experience improved health status. The risk of participating in this study is
      reasonable because of the potential enhancements in metabolic and immune system functioning
      with improved nutritional status.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Improvement in Metabolic Syndrome Markers
time frame: 3 months and 6 months
description: Improvement in glucose, lipid profile, blood pressure, cluster of differentiation 4 (CD4), and cluster of differentiation 8 (CD8) values.
arm group label: rice bran arabinoxylan compound (RBAC)
arm group type: Experimental
description: 2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.
arm group label: placebo
arm group type: Placebo Comparator
description: 2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.
intervention type: Dietary Supplement
intervention name: rice bran arabinoxylan compound (RBAC)
description: 2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.
arm group label: rice bran arabinoxylan compound (RBAC)
intervention type: Dietary Supplement
intervention name: Placebo
description: 2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John E Lewis, Ph.D.
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: John E. Lewis
investigator title: Principal Investigator
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: No