<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/NCT02224092</url>
  </required_header>
  <id_info>
    <org_study_id>Amway-2010-RU1</org_study_id>
    <nct_id>NCT02224092</nct_id>
  </id_info>
  <brief_title>Effects of Supplementation in Healthy Russian Population</brief_title>
  <official_title>Effects of Multivitamin, Multimineral and Phytonutrient Supplementation on Selected Nutrients Blood Level and Heart Health Risk Factors in Russian Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Access Business Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Russian Institute of Nutrition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Access Business Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this exploratory study are to (1) evaluate the effect of the multivitamin&#xD;
      multimineral with phytonutrient product vs. placebo on heart health risk factors following&#xD;
      twice-daily consumption for eight weeks; (2) To test the safety and tolerability of the&#xD;
      multivitamin multimineral with phytonutrient product vs. placebo following twice-daily&#xD;
      consumption for eight weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      More and more evidence shows the benefit of fruit and vegetable intake on the maintenance of&#xD;
      good health throughout the lift span. Unfortunately, many people in developed and developing&#xD;
      societies do not eat a diet with the variety and quantity of fruits and vegetables. Because&#xD;
      of this, prevalence of chronic disease increases rapidly in worldwide as well as the burden&#xD;
      on the health care system. Therefore, promoting healthy lifestyle and dietary behavior&#xD;
      becomes a critical approach in preventing chronic disease development. According to results&#xD;
      from the Moscow Behavioural Risk Factor Survey performed from 2000-2001 found that mean fruit&#xD;
      and vegetable intake in men and women in Moscow was 190 grams per day, much lower than the&#xD;
      World Health Organization's recommended 400 grams per day. This lower than recommended intake&#xD;
      would correlate to a lower intake of phytonutrients and antioxidants and may be associated&#xD;
      with higher risks for chronic diseases such as cardiovascular disease (CVD) and cancer. In&#xD;
      this study, we are particularly interested in understanding whether a multivitamin&#xD;
      multimineral with phytonutrient product can improve nutritional status and reduce heart&#xD;
      health risk factors in Russian population with low fruit and vegetable intake. This study is&#xD;
      conducted in Russia Institute of Nutrition (ION) clinic, which has 200 beds and outpatients&#xD;
      department.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">July 2011</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of heart risk factors by measuring homocysteine, C reactive protein (CRP), oxidized low-density lipoprotein (Ox-LDL) and lipid profile at baseline and Day 56</measure>
    <time_frame>Baseline, Day 56</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of nutrient status by measuring b-carotene, a- and r-tocopherol, vitamin C, folic acid, B6, B12, zinc, selenium, polyphenols at baseline, Day 28 and Day 56</measure>
    <time_frame>Baseline, Day 28 and Day 56</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of potential heart health risk factors by measuring gamma-glutamyl transferase (GGT) and uric acid</measure>
    <time_frame>Baseline and Day 56</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change of anthropomorphic evaluation markers by measuring height, weight, body mass index (BMI, kg/m2), and waist-to-hip ratio at baseline and Day 56</measure>
    <time_frame>Baseline and Day 56</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Evaluation of general health status, lifestyle and dietary behavior</measure>
    <time_frame>Baseline</time_frame>
    <description>dietary questionnaire was used.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Heart Health Markers</condition>
  <condition>General Nutritional Status</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active is a multivitamin multimineral with phytonutrient product.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo is a sugar pill.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>multivitamin multimineral with phytonutrient supplementation</intervention_name>
    <description>The multivitamin multimineral with phytonutrient product consists of four tablets per dose, two &quot;Vitamin&quot; tablets, a &quot;Mineral&quot; tablet, and a &quot;Phytonutrient&quot; tablet. The placebo for this trial will be formulated to match the shape and color of all multivitamin multimineral with phytonutrient product tablets, e.g., a Vitamin Placebo, a Mineral Placebo and a Phytonutrient Placebo.</description>
    <arm_group_label>Active</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Active is Nutrilite Double X</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Generally healthy men and women aged from 40 to 70 years of age preferable smokers and&#xD;
             who regularly consumes alcohol, and consuming fewer than 12 items found on the&#xD;
             Recommended Foods Checklist (see below) per week.&#xD;
&#xD;
          -  Individual should be judged to be in good general health on the basis of an interview&#xD;
             and abbreviated physical exam.&#xD;
&#xD;
          -  Individual understands the procedures and agrees to participate in the study.&#xD;
&#xD;
          -  Individual is able and willing to provide written informed consent and confidentiality&#xD;
             agreement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of dietary supplements within one week of Day 1. Supplements include any vitamins,&#xD;
             minerals, and herbal products, including herbal drinks.&#xD;
&#xD;
          -  Presence of cardiovascular disease, hypercholesterolemia, cancer, diabetes mellitus,&#xD;
             or any other chronic health condition identified from the findings of the interview.&#xD;
&#xD;
          -  Currently treated for uncontrolled hypertension or blood pressure greater &gt; 140 mm Hg&#xD;
             systolic or &gt; 90 mm Hg diastolic during seated, resting measurement on two consecutive&#xD;
             occasions during visit 1.&#xD;
&#xD;
          -  Therapeutic uses of coumadin, aspirin, or other medications that influence hemostasis&#xD;
             within four weeks of Day 1.&#xD;
&#xD;
          -  Participation in another clinical trial within 30 days of enrollment into the study.&#xD;
&#xD;
          -  History or current abuse of drugs or alcohol, or intake &gt; 4 alcoholic beverages per&#xD;
             day.&#xD;
&#xD;
          -  Known hypersensitivity to study product or any ingredient in study product.&#xD;
&#xD;
          -  A change in hormone therapy, including oral contraceptives, within 4 weeks prior to&#xD;
             screening, or unwilling to maintain current hormone therapy/oral contraceptive use&#xD;
             throughout the course of the study.&#xD;
&#xD;
          -  Pregnant or lactating women, or women of child-bearing potential unwilling to use a&#xD;
             medically approved form of birth control.&#xD;
&#xD;
          -  Any condition that the Principal Investigator believes may put the subject at undue&#xD;
             risk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vasily A Isakov, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Russian Institute of Nutrition</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Russian Institute of Nutrition</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>December 19, 2013</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heart health</keyword>
  <keyword>general well-being</keyword>
  <!-- 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/NCT02224092
org study id: Amway-2010-RU1
nct id: NCT02224092
lead sponsor: 
collaborator: 
has dmc: No
The objectives of this exploratory study are to (1) evaluate the effect of the multivitamin
      multimineral with phytonutrient product vs. placebo on heart health risk factors following
      twice-daily consumption for eight weeks; (2) To test the safety and tolerability of the
      multivitamin multimineral with phytonutrient product vs. placebo following twice-daily
      consumption for eight weeks.
More and more evidence shows the benefit of fruit and vegetable intake on the maintenance of
      good health throughout the lift span. Unfortunately, many people in developed and developing
      societies do not eat a diet with the variety and quantity of fruits and vegetables. Because
      of this, prevalence of chronic disease increases rapidly in worldwide as well as the burden
      on the health care system. Therefore, promoting healthy lifestyle and dietary behavior
      becomes a critical approach in preventing chronic disease development. According to results
      from the Moscow Behavioural Risk Factor Survey performed from 2000-2001 found that mean fruit
      and vegetable intake in men and women in Moscow was 190 grams per day, much lower than the
      World Health Organization's recommended 400 grams per day. This lower than recommended intake
      would correlate to a lower intake of phytonutrients and antioxidants and may be associated
      with higher risks for chronic diseases such as cardiovascular disease (CVD) and cancer. In
      this study, we are particularly interested in understanding whether a multivitamin
      multimineral with phytonutrient product can improve nutritional status and reduce heart
      health risk factors in Russian population with low fruit and vegetable intake. This study is
      conducted in Russia Institute of Nutrition (ION) clinic, which has 200 beds and outpatients
      department.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change of heart risk factors by measuring homocysteine, C reactive protein (CRP), oxidized low-density lipoprotein (Ox-LDL) and lipid profile at baseline and Day 56
time frame: Baseline, Day 56
measure: Change of nutrient status by measuring b-carotene, a- and r-tocopherol, vitamin C, folic acid, B6, B12, zinc, selenium, polyphenols at baseline, Day 28 and Day 56
time frame: Baseline, Day 28 and Day 56
measure: Change of potential heart health risk factors by measuring gamma-glutamyl transferase (GGT) and uric acid
time frame: Baseline and Day 56
measure: Change of anthropomorphic evaluation markers by measuring height, weight, body mass index (BMI, kg/m2), and waist-to-hip ratio at baseline and Day 56
time frame: Baseline and Day 56
measure: Evaluation of general health status, lifestyle and dietary behavior
time frame: Baseline
description: dietary questionnaire was used.
arm group label: Active
arm group type: Active Comparator
description: Active is a multivitamin multimineral with phytonutrient product.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo is a sugar pill.
intervention type: Dietary Supplement
intervention name: multivitamin multimineral with phytonutrient supplementation
description: The multivitamin multimineral with phytonutrient product consists of four tablets per dose, two "Vitamin" tablets, a "Mineral" tablet, and a "Phytonutrient" tablet. The placebo for this trial will be formulated to match the shape and color of all multivitamin multimineral with phytonutrient product tablets, e.g., a Vitamin Placebo, a Mineral Placebo and a Phytonutrient Placebo.
arm group label: Active
arm group label: Placebo
other name: Active is Nutrilite Double X
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vasily A Isakov, M.D., Ph.D.
role: Principal Investigator
affiliation: Russian Institute of Nutrition
facility: 
country: Russian Federation
responsible party type: Sponsor