<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/NCT02975089</url>
  </required_header>
  <id_info>
    <org_study_id>AS-IRB-BM-14044</org_study_id>
    <nct_id>NCT02975089</nct_id>
  </id_info>
  <brief_title>A Pilot Study Comparing Effects of Nutrients Supplements and Dietary Approach in Frailty Management</brief_title>
  <official_title>A Pilot Study Comparing Effects of Nutrients Supplements and Dietary Approach in Frailty Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academia Sinica, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Health Research Institutes, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Miao-Li General Hospital, Miao-Li City, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Academia Sinica, Taiwan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proportion of the elderly population has increased rapidly worldwide. Frailty is a common&#xD;
      geriatric syndrome. Comprehensive dietary management strategy may have beneficial effects on&#xD;
      frailty prevention and reversal. We compared the effects between micronutrients and/or&#xD;
      protein supplement, and balanced diet on frailty status in elderly individuals who were at&#xD;
      either pre-frail or frail stage. A total of 37 subjects completed a 3-month paralleled,&#xD;
      single-blind, randomized control trial on (1) multiple nutrients supplementations, (2)&#xD;
      multiple nutrients plus isolated soy protein supplementation, and (3) individualized&#xD;
      nutrition education with designed dishware for balanced diet as well as food supplementations&#xD;
      (mixed nuts and milk powder). Intervention effects on dietary intakes, biomarkers, frailty&#xD;
      score and geriatric depression score (GDS) were assessed. The nutrition education&#xD;
      intervention with designed dishware and milk powder/nuts supplement significantly increased&#xD;
      the intake of vegetables, dairy, and nuts, along with increased concentration of urinary urea&#xD;
      nitrogen of the pre-frail/frail elders. It yielded a significant reduction in frailty score&#xD;
      (p&lt;0.05) and a borderline decrease (p=0.063) in GDS-SF. Our study indicated that the dietary&#xD;
      approach with easy-to-comprehend dishware and food supplements to optimize the distribution&#xD;
      of multiple dietary components showed its potential to improve not only frail status but also&#xD;
      psychological condition in elderly.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changed dietary intake</measure>
    <time_frame>Change from Baseline to month 1 and to month 3</time_frame>
    <description>Usual dietary intake was assessed by inquiring about most frequently consumed breakfast, lunch, dinner, and snack items and the corresponding amounts by licensed dietitians with the assistance of food models and measuring dishware. Dietary intake data were transformed into nutrient data, using a computerized worksheet based on Nutrition and Health Survey Food and Nutrient Database.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changed frailty score</measure>
    <time_frame>Change from baseline to month 1 and to month 3</time_frame>
    <description>All participants were evaluated for frailty, based on the modified Fried criteria. Five frail phenotypes were assigned: (1) unintentional weight loss, (2) self-reported exhaustion, (3) weak grip strength, (4) slow gait speed, and (5) low level of physical activity. For estimating frailty score, participants scored one point from each phenotype if any of which was satisfied with a maximal score of 5 in total. Participants were classified as pre-frail by one point, and as frail by 3 or more points, otherwise as robust.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changed GDS-SF score</measure>
    <time_frame>Change from Baseline to month 1 and to month 3</time_frame>
    <description>Geriatric depression scale-short form (GDS-SF) Chinese version is a 15-item assessment used to identify depression in the elderly. Participants with 5-9 points were at risk of depression, and ≥10 points were depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changed urinary urea nitrogen levels</measure>
    <time_frame>Change from baseline to month 3</time_frame>
    <description>The first morning urine sample was collected by subjects and brought into the hospital for analyzing urinary urea nitrogen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changed urine creatinine levels</measure>
    <time_frame>Change from baseline to month 3</time_frame>
    <description>The first morning urine sample was collected by subjects and brought into the hospital for analyzing urine creatinine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changed nutritional status</measure>
    <time_frame>Change from Baseline to month 1 and to month 3</time_frame>
    <description>Nutritional status was assessed by mini nutritional assessment-short form (MNA-SF). MNA-SF point ≥12 was of normal nutritional status; between 8 and 11 was at risk for malnutrition; ≤7 was at malnutrition status.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Frail Elderly</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A leaflet of healthy diet for elderly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutritional Intervention 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;Multi-nutrient&quot; supplement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutritional Intervention 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;Multi-nutrient &amp; soy protein&quot; supplement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutritional Intervention 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutrition education on balanced diet &amp; food supplement</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>&quot;multi-nutrient&quot; supplement</intervention_name>
    <description>1.3g/d multivitamins &amp; minerals powder&#xD;
Leaflet content (same as control)</description>
    <arm_group_label>Nutritional Intervention 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>&quot;multi-nutrient &amp; soy protein&quot; supplement</intervention_name>
    <description>1.3g/d multivitamins &amp; minerals powder&#xD;
16g/d isolated soy protein powder&#xD;
Leaflet content (same as control)</description>
    <arm_group_label>Nutritional Intervention 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutrition education on balanced diet &amp; food supplement</intervention_name>
    <description>Nutrition education with a designed plate&#xD;
10g/d mixed nuts (cashews, pumpkin seeds, walnuts, macadamia, pine nuts, and almonds)&#xD;
25g/d milk powder (skimmed and calcium added)&#xD;
Leaflet content (same as control)</description>
    <arm_group_label>Nutritional Intervention 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 65 years of age&#xD;
&#xD;
          -  Have at least one of the modified Fried's Frailty phenotypes&#xD;
&#xD;
          -  Sign informed consent form for study participation&#xD;
&#xD;
        Modified Fried's Frailty phenotypes:&#xD;
&#xD;
          1. unintentional weight loss &gt; 5% or 3 kg in previous year&#xD;
&#xD;
          2. Exhaustion: defined as positive answer to the question &quot;I had felt fatigue or&#xD;
             exhaustion for &gt;3 days in the previous week&quot;&#xD;
&#xD;
          3. Weakness: hand grip strength is below the gender and BMI specific thresholds. The&#xD;
             cutoff points are set as follows:&#xD;
&#xD;
             Men: For BMI ≤ 22.1, &lt; 25.0 kg; for BMI 22.1-24.3, &lt; 26.5 kg; for BMI 24.4-26.3, &lt;&#xD;
             26.4 kg; for BMI ≥ 26.3, &lt; 27.2 kg Women: for BMI ≤ 22.3, &lt;14.6 kg; for BMI 22.3-24.2,&#xD;
             &lt;16.1 kg; for BMI 24.3-26.8, &lt;16.5 kg; for BMI ≥ 26.8, &lt; 16.4 kg&#xD;
&#xD;
          4. Slowness: gait speed is slower than the gender and height specific thresholds. The&#xD;
             cutoff points are set as follows:&#xD;
&#xD;
             Men: for height ≤ 163 cm, &gt;14.92 sec/10m; for &gt; 163 cm, &gt;=14.08 sec/10m Women: for&#xD;
             height ≤ 152 cm, &gt;17.54 sec/10m; for &gt; 152 cm, &gt;=14.92 sec/10m&#xD;
&#xD;
          5. Low Physical Activity: No exercise and no labor or leisure-time physical activity in&#xD;
             the past year, or below the calorie consumption: men &lt;594kcal/week and women&#xD;
             &lt;295kcal/week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe illness (such as cancer under treatment), being bed-ridden, or unable to move&#xD;
&#xD;
          2. Diagnosed dementia, depression, psychosis, mental disorder, or cannot be effectively&#xD;
             communicated with（e.g., MMSE&lt;16）&#xD;
&#xD;
          3. Dumbness, severe hearing or visual impairment, or unable to complete the interview&#xD;
&#xD;
          4. Institutionalized individuals, such as living in a long-term care facility or being&#xD;
             hospitalized&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wen-Harn Pan, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Biomedical Sciences, Academia Sinica</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academia Sinica, Taiwan</investigator_affiliation>
    <investigator_full_name>Wen-Harn Pan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Frailty</keyword>
  <keyword>nutrition education</keyword>
  <keyword>designed dishware</keyword>
  <keyword>balanced diet</keyword>
  <keyword>multiple dietary components</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>December 1, 2016</submitted>
    <returned>January 25, 2017</returned>
    <submitted>October 5, 2017</submitted>
    <returned>July 13, 2018</returned>
  </pending_results>
  <!-- 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/NCT02975089
org study id: AS-IRB-BM-14044
nct id: NCT02975089
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The proportion of the elderly population has increased rapidly worldwide. Frailty is a common
      geriatric syndrome. Comprehensive dietary management strategy may have beneficial effects on
      frailty prevention and reversal. We compared the effects between micronutrients and/or
      protein supplement, and balanced diet on frailty status in elderly individuals who were at
      either pre-frail or frail stage. A total of 37 subjects completed a 3-month paralleled,
      single-blind, randomized control trial on (1) multiple nutrients supplementations, (2)
      multiple nutrients plus isolated soy protein supplementation, and (3) individualized
      nutrition education with designed dishware for balanced diet as well as food supplementations
      (mixed nuts and milk powder). Intervention effects on dietary intakes, biomarkers, frailty
      score and geriatric depression score (GDS) were assessed. The nutrition education
      intervention with designed dishware and milk powder/nuts supplement significantly increased
      the intake of vegetables, dairy, and nuts, along with increased concentration of urinary urea
      nitrogen of the pre-frail/frail elders. It yielded a significant reduction in frailty score
      (p<0.05) and a borderline decrease (p=0.063) in GDS-SF. Our study indicated that the dietary
      approach with easy-to-comprehend dishware and food supplements to optimize the distribution
      of multiple dietary components showed its potential to improve not only frail status but also
      psychological condition in elderly.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Changed dietary intake
time frame: Change from Baseline to month 1 and to month 3
description: Usual dietary intake was assessed by inquiring about most frequently consumed breakfast, lunch, dinner, and snack items and the corresponding amounts by licensed dietitians with the assistance of food models and measuring dishware. Dietary intake data were transformed into nutrient data, using a computerized worksheet based on Nutrition and Health Survey Food and Nutrient Database.
measure: Changed frailty score
time frame: Change from baseline to month 1 and to month 3
description: All participants were evaluated for frailty, based on the modified Fried criteria. Five frail phenotypes were assigned: (1) unintentional weight loss, (2) self-reported exhaustion, (3) weak grip strength, (4) slow gait speed, and (5) low level of physical activity. For estimating frailty score, participants scored one point from each phenotype if any of which was satisfied with a maximal score of 5 in total. Participants were classified as pre-frail by one point, and as frail by 3 or more points, otherwise as robust.
measure: Changed GDS-SF score
time frame: Change from Baseline to month 1 and to month 3
description: Geriatric depression scale-short form (GDS-SF) Chinese version is a 15-item assessment used to identify depression in the elderly. Participants with 5-9 points were at risk of depression, and ≥10 points were depression.
measure: Changed urinary urea nitrogen levels
time frame: Change from baseline to month 3
description: The first morning urine sample was collected by subjects and brought into the hospital for analyzing urinary urea nitrogen.
measure: Changed urine creatinine levels
time frame: Change from baseline to month 3
description: The first morning urine sample was collected by subjects and brought into the hospital for analyzing urine creatinine.
measure: Changed nutritional status
time frame: Change from Baseline to month 1 and to month 3
description: Nutritional status was assessed by mini nutritional assessment-short form (MNA-SF). MNA-SF point ≥12 was of normal nutritional status; between 8 and 11 was at risk for malnutrition; ≤7 was at malnutrition status.
arm group label: Control
arm group type: No Intervention
description: A leaflet of healthy diet for elderly
arm group label: Nutritional Intervention 1
arm group type: Experimental
description: "Multi-nutrient" supplement
arm group label: Nutritional Intervention 2
arm group type: Experimental
description: "Multi-nutrient & soy protein" supplement
arm group label: Nutritional Intervention 3
arm group type: Experimental
description: Nutrition education on balanced diet & food supplement
intervention type: Dietary Supplement
intervention name: "multi-nutrient" supplement
description: 1.3g/d multivitamins & minerals powder
Leaflet content (same as control)
arm group label: Nutritional Intervention 1
intervention type: Dietary Supplement
intervention name: "multi-nutrient & soy protein" supplement
description: 1.3g/d multivitamins & minerals powder
16g/d isolated soy protein powder
Leaflet content (same as control)
arm group label: Nutritional Intervention 2
intervention type: Dietary Supplement
intervention name: Nutrition education on balanced diet & food supplement
description: Nutrition education with a designed plate
10g/d mixed nuts (cashews, pumpkin seeds, walnuts, macadamia, pine nuts, and almonds)
25g/d milk powder (skimmed and calcium added)
Leaflet content (same as control)
arm group label: Nutritional Intervention 3
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Wen-Harn Pan, Ph.D.
role: Principal Investigator
affiliation: Institute of Biomedical Sciences, Academia Sinica
responsible party type: Principal Investigator
investigator affiliation: Academia Sinica, Taiwan
investigator full name: Wen-Harn Pan
investigator title: Professor
mesh term: Frailty
submitted: December 1, 2016
returned: January 25, 2017
submitted: October 5, 2017
returned: July 13, 2018