<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/NCT03004807</url>
  </required_header>
  <id_info>
    <org_study_id>WI211838</org_study_id>
    <secondary_id>7158</secondary_id>
    <nct_id>NCT03004807</nct_id>
  </id_info>
  <brief_title>Role of Centrum® Silver® in Improving Micronutrient Status in Older Men</brief_title>
  <official_title>Role of Centrum® Silver® in Improving Micronutrient Status in Older Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tory Hagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Oregon State University</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>
      Older adults are susceptible to vitamin and mineral deficiencies for a variety of reasons and&#xD;
      have an increased demand for many of these micronutrients. Multivitamin/multimineral&#xD;
      supplement offer a simple way for adults to improve nutrient intake, but their ability to&#xD;
      measurably affect micronutrient status in older adults has never been explored. This study&#xD;
      intends to recruit healthy, non-smoking men aged 65 years or older. After meeting entry&#xD;
      criteria, subjects will be required to restrict the use of supplements and/or fortified&#xD;
      foods. Two months after these restrictions have begun, subjects will come to the clinical&#xD;
      research center to take cognitive tests, undergo activity monitoring, provide blood samples&#xD;
      for nutrition testing, and take food frequency questionnaires. Subjects will then be&#xD;
      randomized into one of two groups - one consuming a multivitamin/multimineral supplement&#xD;
      (Centrum Silver Mens Formula); another consuming an inert placebo tablet. Subjects will&#xD;
      consume 1 tablet each day for six months. After this period, subjects will return to the&#xD;
      clinical research center and repeat cognitive tests, activity monitor, blood sampling, and&#xD;
      food frequency questionnaires. These data will be assessed to determine if multivitamin&#xD;
      consumption results in changes in various nutrients versus taking a placebo (primary&#xD;
      outcomes), and may results in changes lipid and lipoprotein profiles, metabolic health,&#xD;
      inflammation, blood pressure or cognitive function (secondary outcomes). The investigators&#xD;
      expect that results of this study will add to the general understanding if&#xD;
      multivitamin/multimineral formulas can improve nutrition status of older adults, and&#xD;
      therefore have the capacity of altering markers of health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Older adults are at increased risk of various chronic diseases, in which inadequate levels of&#xD;
      vitamins and minerals may play a significant role, including cardiovascular disease,&#xD;
      Alzheimer's disease, liver disease, and cancer. Most adults in the United States do not meet&#xD;
      the Recommended Dietary Allowance (RDA) or Adequate Intake (AI) of many vitamins and&#xD;
      nutritionally-essential minerals from diet alone, including vitamins A, C, D, E and K,&#xD;
      calcium, magnesium, and potassium. Older adults are particularly susceptible to micronutrient&#xD;
      inadequacies because of limited absorption, increased requirements, or - in the case of&#xD;
      vitamin D - decreased synthetic capacity in the skin. Thus, there is a strong rationale for&#xD;
      supplementing the diets of older adults with a multivitamin/multimineral supplement, such as&#xD;
      Centrum® Silver®. However, little is currently known about the bioavailability of the&#xD;
      Centrum® Silver® formula in this age demographic.&#xD;
&#xD;
      Epidemiological studies and recent clinical trials have shown that use of&#xD;
      multivitamin/mineral supplements has beneficial effects on disease risk in men, including&#xD;
      those of advanced age. It is assumed that these benefits of multivitamin/mineral supplements&#xD;
      are achieved through changes in nutrition status. However, it has never been documented if&#xD;
      there are concomitant changes in micronutrient levels in individuals who consume these&#xD;
      supplements. Furthermore, changes in nutritional status in older individuals taking&#xD;
      multivitamin/multimineral supplements are a subject that has yet to be explored.&#xD;
&#xD;
      Therefore, this study seeks to recruit men who are in generally good health, 65 years of age&#xD;
      or older, to assess their vitamin and mineral status before and after six months&#xD;
      (approximately 24 weeks) of supplementation with Centrum® Silver®. The investigators&#xD;
      hypothesize that consuming multivitamin/multimineral supplements everyday will result in&#xD;
      measurable increases in the status of one or more vitamins or minerals in the body.&#xD;
      Concentrations of several vitamins and minerals in blood samples will be performed, along&#xD;
      with a general assessment of micronutrient status in white blood cells (primary outcomes). To&#xD;
      see if these changes in nutrition status impact other aspects of human health, changes in&#xD;
      lipid and lipoprotein profiles, antioxidant status, metabolic health, and inflammation and&#xD;
      treatment differences in cognitive function will be assessed (secondary outcomes). Centrum®&#xD;
      Silver® supplementation may or may not have any effect on these secondary outcomes, when&#xD;
      compared to a placebo, unless there are measurable changes in the primary outcomes.&#xD;
&#xD;
      The expectation is that the results of this research will add to a general understanding of&#xD;
      multivitamin/mineral supplements and how well they can improve the nutritional status of&#xD;
      older adults. By employing direct and functional methods to assay for nutritional content,&#xD;
      this study will determine how well these methods correlate and by using both assay methods&#xD;
      unique insight into the mechanism(s) whereby multivitamin/multimineral supplements might or&#xD;
      might not lead to improvements in health may be ascertained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2021</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Plasma and Blood Cell Vitamin and Mineral Levels</measure>
    <time_frame>Between baseline (visit 3) and 6 months after intervention begins (visit 7)</time_frame>
    <description>Blood samples will be collected at baseline and end of intervention. Plasma levels of beta carotene, pyridoxine (vitamin B6), cobalamin (vitamin B12), ascorbic acid (vitamin C), 25-hydroxy vitamin D, α- tocopherol (vitamin E), and phylloquinone/menaquinones (vitamin K) will be determined. Analyses will be performed for absolute values and values corrected for total lipids where necessary. Folate will be assessed in red blood cells. Minerals analysis by inductively coupled plasma atomic emission spectroscopy (ICP-AES) will be performed in plasma or lymphocytes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lipid Status</measure>
    <time_frame>Between baseline (visit 3) and 6 months after intervention begins (visit 7)</time_frame>
    <description>Changes to fasting lipoprotein and triglyceride status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High Resolution Respirometry</measure>
    <time_frame>Between baseline (visit 3) and 6 months after intervention begins (visit 7)</time_frame>
    <description>Isolated white blood cells will be evaluated in the Oroboros Oxygraph (Innsbruck, Austria) to evaluate the capacity of mitochondria to sustain respiration/energy demands</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive abilities</measure>
    <time_frame>Between cognitive baseline (visit 2) and 6 months after intervention begins (visit 6)</time_frame>
    <description>Cognitive abilities will be assessed by the following NIH Toolbox measures: Picture Vocabulary, Flanker Inhibitory Control and Attention Test, Sorting Working Memory Test, Dimensional Change Card Sort Test, Pattern Completion Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition Test. The individual test scores are based on time and accuracy, will be normalized to scaled scores, and averaged to obtain a Fluid Cognition Composite score, as calculated by the NIH Toolbox scoring algorithms. Significant changes in total score after intervention, or between intervention and control groups will be recorded. Logical Memory will be tested with recall of narrative story both immediate and delayed as described in Wechsler Memory Scale-IV Protocol. Additionally, a &quot;Head-Toes-Knees-Shoulders Task&quot; that combines physical activity with processing speed and accuracy will also be assessed at the completion of each session.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spatial memory as assessed by a virtual water maze</measure>
    <time_frame>At visit 6, approximately 6 months after intervention begins, 1 week before visit 7</time_frame>
    <description>A computerized environment will be presented for the subject that can be navigated with a joystick. The goal is to find a hidden platform based on spatial clues. Search accuracy for the target platform in the environment will be assessed between trials. Changes in proximity to the platform will be compared between successive trials in an individual, and also between individuals in the placebo control and multivitamin intervention groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crystallized cognitive abilities</measure>
    <time_frame>1 week before intervention begins (visit 2) and 1 week before intervention ends (visit 6)</time_frame>
    <description>Crystallized abilities will be assessed with NIH Toolbox Oral Reading Recognition Test and NIH Toolbox Picture Vocabulary Test. The individual test scores will be determined after adjusting for computer adaptive testing, normalized to scaled scores, and averaged to obtain a Crystallized Cognition Composite score, as calculated by the NIH Toolbox scoring algorithms. Significant changes in total score after intervention, or between intervention and control groups will be recorded.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Activity Monitoring</measure>
    <time_frame>Between visit 2 and visit 3 (duration: 1 week) and visit 6 and visit 7 (duration: 1 week)</time_frame>
    <description>Wrist activity monitors (FitBit, commercial model) will be worn by subjects at the given intervals. General activity level, calories burned, heart rate, and steps taken will be recorded to give a general assessment of &quot;energy level&quot;.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Vitamin Deficiency</condition>
  <condition>Mineral Deficiency</condition>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Multivitamin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Centrum Silver Men's Formula Multivitamin/Multimineral Supplement: 1/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching tablet to active multivitamin arm: 1/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Centrum Silver Mens' Formula</intervention_name>
    <description>Multivitamin/Multimineral dietary supplement produced for Pfizer for use in older men.</description>
    <arm_group_label>Multivitamin</arm_group_label>
    <other_name>Centrum Silver Men</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>A matching tablet to the dietary supplement, but without any active ingredients</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Placebo Comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants must be willing to:&#xD;
&#xD;
          -  Consume a multivitamin/mineral supplement or placebo tablet each day during the&#xD;
             6-month study period&#xD;
&#xD;
          -  Fill out online food frequency questionnaires&#xD;
&#xD;
          -  Refrain from taking vitamin and mineral supplements that match micronutrients found in&#xD;
             Centrum Silver (including certain antacids, energy drinks, fortified cereals, or&#xD;
             nutritional shakes) other than those provided during the study. . Current users of&#xD;
             supplements must agree to stop taking these supplements for two months before the&#xD;
             study begins.&#xD;
&#xD;
          -  Wear an activity monitor about the wrist continuously for two one-week periods, except&#xD;
             when exposed to water, before and during multivitamin supplementation.&#xD;
&#xD;
          -  Give blood samples on 3 separate occasions&#xD;
&#xD;
          -  Participate in cognitive testing procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently taking supplements as recommended/ordered by a physician to correct a&#xD;
             nutritional deficiency, with an exception for vitamins or minerals not found in&#xD;
             Centrum Silver (as outlined in a Post-Screen Drug and Supplement Review).&#xD;
&#xD;
          -  Current or recent (two years) history of smoking (tobacco or marijuana)&#xD;
&#xD;
          -  Dysphagia or difficulty swallowing.&#xD;
&#xD;
          -  Bariatric (gastric bypass) surgery or serious chronic illness that might affect&#xD;
             absorption of multivitamins or minerals such as Crohn's disease, unmanaged celiac&#xD;
             disease, chronic diarrhea, ulcerative colitis, gastritis, or a diagnosis of&#xD;
             malabsorption syndrome.&#xD;
&#xD;
          -  A diagnosis of cancer with chemotherapy or radiation treatment during the previous 5&#xD;
             years.&#xD;
&#xD;
          -  Major surgery in the past 6 months or planned major surgery during the duration of the&#xD;
             study.&#xD;
&#xD;
          -  Prior heart attack, stroke, or heart failure.&#xD;
&#xD;
          -  Uncontrolled stage II hypertension (blood pressure above 159/99 mm Hg).&#xD;
&#xD;
          -  A current diagnosis of kidney, liver, or thyroid disease.&#xD;
&#xD;
          -  Diabetes (Type 1 or Type 2).&#xD;
&#xD;
          -  History of hypoglycemia or low blood sugar.&#xD;
&#xD;
          -  Hb1ac levels &gt; 6.4%.&#xD;
&#xD;
          -  Fail a Post-Screen Drug and Supplement Review.&#xD;
&#xD;
          -  BMI &lt; 18.5 or &gt; 35&#xD;
&#xD;
          -  History of psychological or neurological disorders, or a diagnosis of dementia.&#xD;
&#xD;
          -  Head injury with loss of consciousness of &gt; 5 minutes in the last 5 years.&#xD;
&#xD;
          -  Chronic Migraines - More than fifteen headache days per month over a three-month&#xD;
             period of which more than eight are migraines.&#xD;
&#xD;
          -  Score &lt; 26 on the mini-mental state exam.&#xD;
&#xD;
          -  Present treatment for drug or alcohol problems.&#xD;
&#xD;
          -  Habit of taking three or more alcoholic drinks per day.&#xD;
&#xD;
          -  Corrected visual acuity worse than 20/50.&#xD;
&#xD;
          -  Anyone who cannot handwrite a letter or move a computer joystick with one of their&#xD;
             hands.&#xD;
&#xD;
          -  Cannot hear well enough to understand spoken instructions.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tory M Hagen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alexander J Michels, PhD</last_name>
    <phone>541-737-8730</phone>
    <email>Alexander.Michels@oregonstate.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sandra Uesugi, RN</last_name>
    <phone>541-737-3594</phone>
    <email>Sandra.Uesugi@oregonstate.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Linus Pauling Science Center</name>
      <address>
        <city>Corvallis</city>
        <state>Oregon</state>
        <zip>97331</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexander J Michels, PhD</last_name>
      <phone>541-737-8730</phone>
      <email>Alexander.Michels@oregonstate.edu</email>
    </contact>
    <contact_backup>
      <last_name>Sandra Uesugi, RN</last_name>
      <phone>541-737-3594</phone>
      <email>Sandra.Uesugi@oregonstate.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Tory M Hagen, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kathy Magnusson, PhD, DVM</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>February 22, 2021</last_update_submitted>
  <last_update_submitted_qc>February 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Oregon State University</investigator_affiliation>
    <investigator_full_name>Tory Hagen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Nutrition</keyword>
  <keyword>Aging</keyword>
  <keyword>Multivitamin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Avitaminosis</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/NCT03004807
org study id: WI211838
secondary id: 7158
nct id: NCT03004807
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Older adults are susceptible to vitamin and mineral deficiencies for a variety of reasons and
      have an increased demand for many of these micronutrients. Multivitamin/multimineral
      supplement offer a simple way for adults to improve nutrient intake, but their ability to
      measurably affect micronutrient status in older adults has never been explored. This study
      intends to recruit healthy, non-smoking men aged 65 years or older. After meeting entry
      criteria, subjects will be required to restrict the use of supplements and/or fortified
      foods. Two months after these restrictions have begun, subjects will come to the clinical
      research center to take cognitive tests, undergo activity monitoring, provide blood samples
      for nutrition testing, and take food frequency questionnaires. Subjects will then be
      randomized into one of two groups - one consuming a multivitamin/multimineral supplement
      (Centrum Silver Mens Formula); another consuming an inert placebo tablet. Subjects will
      consume 1 tablet each day for six months. After this period, subjects will return to the
      clinical research center and repeat cognitive tests, activity monitor, blood sampling, and
      food frequency questionnaires. These data will be assessed to determine if multivitamin
      consumption results in changes in various nutrients versus taking a placebo (primary
      outcomes), and may results in changes lipid and lipoprotein profiles, metabolic health,
      inflammation, blood pressure or cognitive function (secondary outcomes). The investigators
      expect that results of this study will add to the general understanding if
      multivitamin/multimineral formulas can improve nutrition status of older adults, and
      therefore have the capacity of altering markers of health.
Older adults are at increased risk of various chronic diseases, in which inadequate levels of
      vitamins and minerals may play a significant role, including cardiovascular disease,
      Alzheimer's disease, liver disease, and cancer. Most adults in the United States do not meet
      the Recommended Dietary Allowance (RDA) or Adequate Intake (AI) of many vitamins and
      nutritionally-essential minerals from diet alone, including vitamins A, C, D, E and K,
      calcium, magnesium, and potassium. Older adults are particularly susceptible to micronutrient
      inadequacies because of limited absorption, increased requirements, or - in the case of
      vitamin D - decreased synthetic capacity in the skin. Thus, there is a strong rationale for
      supplementing the diets of older adults with a multivitamin/multimineral supplement, such as
      Centrum® Silver®. However, little is currently known about the bioavailability of the
      Centrum® Silver® formula in this age demographic.

      Epidemiological studies and recent clinical trials have shown that use of
      multivitamin/mineral supplements has beneficial effects on disease risk in men, including
      those of advanced age. It is assumed that these benefits of multivitamin/mineral supplements
      are achieved through changes in nutrition status. However, it has never been documented if
      there are concomitant changes in micronutrient levels in individuals who consume these
      supplements. Furthermore, changes in nutritional status in older individuals taking
      multivitamin/multimineral supplements are a subject that has yet to be explored.

      Therefore, this study seeks to recruit men who are in generally good health, 65 years of age
      or older, to assess their vitamin and mineral status before and after six months
      (approximately 24 weeks) of supplementation with Centrum® Silver®. The investigators
      hypothesize that consuming multivitamin/multimineral supplements everyday will result in
      measurable increases in the status of one or more vitamins or minerals in the body.
      Concentrations of several vitamins and minerals in blood samples will be performed, along
      with a general assessment of micronutrient status in white blood cells (primary outcomes). To
      see if these changes in nutrition status impact other aspects of human health, changes in
      lipid and lipoprotein profiles, antioxidant status, metabolic health, and inflammation and
      treatment differences in cognitive function will be assessed (secondary outcomes). Centrum®
      Silver® supplementation may or may not have any effect on these secondary outcomes, when
      compared to a placebo, unless there are measurable changes in the primary outcomes.

      The expectation is that the results of this research will add to a general understanding of
      multivitamin/mineral supplements and how well they can improve the nutritional status of
      older adults. By employing direct and functional methods to assay for nutritional content,
      this study will determine how well these methods correlate and by using both assay methods
      unique insight into the mechanism(s) whereby multivitamin/multimineral supplements might or
      might not lead to improvements in health may be ascertained.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
measure: Changes in Plasma and Blood Cell Vitamin and Mineral Levels
time frame: Between baseline (visit 3) and 6 months after intervention begins (visit 7)
description: Blood samples will be collected at baseline and end of intervention. Plasma levels of beta carotene, pyridoxine (vitamin B6), cobalamin (vitamin B12), ascorbic acid (vitamin C), 25-hydroxy vitamin D, α- tocopherol (vitamin E), and phylloquinone/menaquinones (vitamin K) will be determined. Analyses will be performed for absolute values and values corrected for total lipids where necessary. Folate will be assessed in red blood cells. Minerals analysis by inductively coupled plasma atomic emission spectroscopy (ICP-AES) will be performed in plasma or lymphocytes.
measure: Lipid Status
time frame: Between baseline (visit 3) and 6 months after intervention begins (visit 7)
description: Changes to fasting lipoprotein and triglyceride status
measure: High Resolution Respirometry
time frame: Between baseline (visit 3) and 6 months after intervention begins (visit 7)
description: Isolated white blood cells will be evaluated in the Oroboros Oxygraph (Innsbruck, Austria) to evaluate the capacity of mitochondria to sustain respiration/energy demands
measure: Cognitive abilities
time frame: Between cognitive baseline (visit 2) and 6 months after intervention begins (visit 6)
description: Cognitive abilities will be assessed by the following NIH Toolbox measures: Picture Vocabulary, Flanker Inhibitory Control and Attention Test, Sorting Working Memory Test, Dimensional Change Card Sort Test, Pattern Completion Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition Test. The individual test scores are based on time and accuracy, will be normalized to scaled scores, and averaged to obtain a Fluid Cognition Composite score, as calculated by the NIH Toolbox scoring algorithms. Significant changes in total score after intervention, or between intervention and control groups will be recorded. Logical Memory will be tested with recall of narrative story both immediate and delayed as described in Wechsler Memory Scale-IV Protocol. Additionally, a "Head-Toes-Knees-Shoulders Task" that combines physical activity with processing speed and accuracy will also be assessed at the completion of each session.
measure: Spatial memory as assessed by a virtual water maze
time frame: At visit 6, approximately 6 months after intervention begins, 1 week before visit 7
description: A computerized environment will be presented for the subject that can be navigated with a joystick. The goal is to find a hidden platform based on spatial clues. Search accuracy for the target platform in the environment will be assessed between trials. Changes in proximity to the platform will be compared between successive trials in an individual, and also between individuals in the placebo control and multivitamin intervention groups.
measure: Crystallized cognitive abilities
time frame: 1 week before intervention begins (visit 2) and 1 week before intervention ends (visit 6)
description: Crystallized abilities will be assessed with NIH Toolbox Oral Reading Recognition Test and NIH Toolbox Picture Vocabulary Test. The individual test scores will be determined after adjusting for computer adaptive testing, normalized to scaled scores, and averaged to obtain a Crystallized Cognition Composite score, as calculated by the NIH Toolbox scoring algorithms. Significant changes in total score after intervention, or between intervention and control groups will be recorded.
measure: Activity Monitoring
time frame: Between visit 2 and visit 3 (duration: 1 week) and visit 6 and visit 7 (duration: 1 week)
description: Wrist activity monitors (FitBit, commercial model) will be worn by subjects at the given intervals. General activity level, calories burned, heart rate, and steps taken will be recorded to give a general assessment of "energy level".
arm group label: Multivitamin
arm group type: Experimental
description: Centrum Silver Men's Formula Multivitamin/Multimineral Supplement: 1/day
arm group label: Control
arm group type: Placebo Comparator
description: Matching tablet to active multivitamin arm: 1/day
intervention type: Dietary Supplement
intervention name: Centrum Silver Mens' Formula
description: Multivitamin/Multimineral dietary supplement produced for Pfizer for use in older men.
arm group label: Multivitamin
other name: Centrum Silver Men
intervention type: Other
intervention name: Control
description: A matching tablet to the dietary supplement, but without any active ingredients
arm group label: Control
other name: Placebo Comparator
criteria: 
gender: Male
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tory M Hagen, PhD
role: Principal Investigator
affiliation: Oregon State University
last name: Alexander J Michels, PhD
phone: 541-737-8730
email: Alexander.Michels@oregonstate.edu
last name: Sandra Uesugi, RN
phone: 541-737-3594
email: Sandra.Uesugi@oregonstate.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Oregon State University
investigator full name: Tory Hagen
investigator title: Professor
mesh term: Avitaminosis
sharing ipd: No