<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/NCT04454359</url>
  </required_header>
  <id_info>
    <org_study_id>15-633-MUHC</org_study_id>
    <nct_id>NCT04454359</nct_id>
  </id_info>
  <brief_title>Multi-nutrient Supplement to Improve Physical Performance in Older Adults</brief_title>
  <official_title>Nutritional Supplement to Improve Physical Performance in Geriatric Day Hospital Participants: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Réseau québécois de recherche sur le vieillissement</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>MUHC-Montreal General Hospital Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McGill 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>
      Geriatric Day Hospitals (GDH) of the McGill University Health Centre and l'Institut de&#xD;
      Gériatrie de Montreal offer comprehensive rehabilitation programs including physiotherapy and&#xD;
      medical care, but no dietetic counselling for the attending frail population at high risk of&#xD;
      malnutrition. This study aims to implement a multi-nutrient supplement to further improve&#xD;
      nutritional status, physical function and capacity. A whey protein, leucine, vitamin D and&#xD;
      omega-3 fatty acid supplement ingested during 16 weeks will be tested versus an isocaloric&#xD;
      placebo on measures of physical performance and muscle mass and strength, in GDH&#xD;
      participants. The specific objective of this pilot-study is to test feasibility and&#xD;
      adherence; pilot data could lead to a larger trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RATIONALE Given the high prevalence of malnutrition of the GDH participants and its impact on&#xD;
      poor physical performance, providing a nutritional supplement to increase protein, leucine,&#xD;
      vitamin D and omega-3 FA intake should complement and optimize the rehabilitation&#xD;
      interventions in improving muscle mass, strength and physical performance.&#xD;
&#xD;
      OBJECTIVES&#xD;
&#xD;
      Implementing the proposed nutritional supplement in the routine care of GDH participants&#xD;
      will:&#xD;
&#xD;
        1. test the feasibility, acceptance and adherence to the supplement and its safety&#xD;
&#xD;
        2. provide pilot data to test the superiority of the supplement versus an isocaloric&#xD;
           placebo on measures of muscle mass, strength, and physical performance.&#xD;
&#xD;
      STUDY DESIGN. This is a randomized, placebo-controlled, double-blinded trial of two parallel&#xD;
      arms, conducted on two sites. Eligible participants will be randomly assigned to one of two&#xD;
      groups: experimental (EXP) or control (CTR) in a 1:1 ratio. Randomization will be achieved by&#xD;
      computer-generated permuted block of four.&#xD;
&#xD;
      INTERVENTION The EXP arm will ingest a multi-nutrient supplement consisting of whey protein +&#xD;
      leucine and fish oil + vitamin D and CTR arm will ingest an isocaloric plabebo, during 16&#xD;
      weeks (about 8 weeks during rehabilitation and 8 more weeks after). Outcome assessment will&#xD;
      be performed at baseline, week 8 and week 16, except for body composition measured by DXA at&#xD;
      baseline and week 16.&#xD;
&#xD;
      OUTCOMES Primary: feasibility Secondary: physical performance, muscle strength, appendicular&#xD;
      lean mass Other: dietary intake, physical activity, clinical markers&#xD;
&#xD;
      STATISTICAL ANALYSIS This pilot study is designed to generate data on feasibility, acceptance&#xD;
      and compliance to the supplement and is not powered for identifying statistical differences&#xD;
      in the secondary outcomes. A sample size of n=40 (20/group) is planned to test feasibility.&#xD;
      Data will be reported as medians and 95% CI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2016</start_date>
  <completion_date type="Actual">March 10, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</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>
    <intervention_model_description>Randomized, placebo-controlled, double-blinded pilot trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Isocaloric placebos of same taste and texture as the experimental supplements</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility: recruitment rate</measure>
    <time_frame>Recruitment over 2 years</time_frame>
    <description>Recruitment rate (measured in %, compared to expected rates)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility: adherence to intervention</measure>
    <time_frame>Over 16 weeks</time_frame>
    <description>Adherence to supplements (measured in %, compared to expected rates)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility: completion</measure>
    <time_frame>Over 16 weeks</time_frame>
    <description>Completion of study outcome assessments (measured in %, compared to expected rates)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6-minute walking test</measure>
    <time_frame>Weeks 0, 8 and 16</time_frame>
    <description>6-minute walking test (measured as the distance walked during 6 minutes, along a 30-m corridor, expressed in m)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chair stand test</measure>
    <time_frame>Weeks 0, 8 and 16</time_frame>
    <description>30-second chair stand test: measured as the number of stands from a chair without arms, in 30 sec)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed-up-and-go test</measure>
    <time_frame>Weeks 0, 8 and 16</time_frame>
    <description>Timed-up-and-go (time to get up from a chair without armrest, walk 3 m and return to sit down completely on the chair, measured in seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Handgrip strength</measure>
    <time_frame>Weeks 0, 8 and 16</time_frame>
    <description>Maximal handgrip strength (using hand-held Jamar dynamometer, measured in kg),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leg strength</measure>
    <time_frame>Weeks 0, 8 and 16</time_frame>
    <description>Isometric knee extension peak torque (using Biodex, measured in N)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appendicular lean mass</measure>
    <time_frame>Weeks 0 and 16</time_frame>
    <description>Sum of soft lean mass from arms and legs (measured by iDXA, in kg)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Protein intake</measure>
    <time_frame>Weeks 0, 8 and 16</time_frame>
    <description>Protein intake (g) from foods and supplements, estimated from 3-day food diary (using Food Processor with Canadian Nutrient File)</description>
  </other_outcome>
  <other_outcome>
    <measure>Step counts</measure>
    <time_frame>Weeks 0, 8 and 16</time_frame>
    <description>Measured by accelerometry during 4 days (Actigraph)</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum albumin</measure>
    <time_frame>Weeks 0, 8 and 16</time_frame>
    <description>Albumin, in g/L (measured by the MUHC biochemical laboratory)</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum pre-albumin</measure>
    <time_frame>Weeks 0, 8 and 16</time_frame>
    <description>Pre-albumin, in mg/L (measured by the MUHC biochemical laboratory)</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum C-reactive Protein</measure>
    <time_frame>Weeks 0, 8 and 16</time_frame>
    <description>CRP, in mg/L (measured by the MUHC biochemical laboratory)</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum Vitamin D</measure>
    <time_frame>Weeks 0, 8 and 16</time_frame>
    <description>Vitamin D status, 25(OH)D, in nmol/L (measured by the MUHC biochemical laboratory)</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma glucose</measure>
    <time_frame>Weeks 0, 8 and 16</time_frame>
    <description>Glucose, in mmol/L (measured with glucose oxidase method)</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum IGF-1</measure>
    <time_frame>Weeks 0, 8 and 16</time_frame>
    <description>IGF-1, in ng/mL (measured by ELISA)</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma phospholipid omega-3 fatty acids</measure>
    <time_frame>Weeks 0, 8 and 16</time_frame>
    <description>EPA and DHA, expressed as a proportion (%) over total; used as an objective measure of adherence to fish oil supplement (measured by gas chromatography-flame ionization)</description>
  </other_outcome>
  <other_outcome>
    <measure>Energy intake</measure>
    <time_frame>Weeks 0, 8 and 16</time_frame>
    <description>energy intake (kcal) from average of 3-day food diary (using Food Processor with Canadian Nutrient File)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Old Age</condition>
  <arm_group>
    <arm_group_label>EXP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EXP group will ingest a supplement consisting of 1) flavored whey protein isolate with added pure leucine (3 g) diluted in water, twice daily, before breakfast and before bedtime; doses are adjusted per body weight as follows: 20 g, 25 g or 30 g per category of &lt;65 kg, 65-75 kg and &gt;75 kg of body weight respectively. 2) fish oil containing vitamin D, provided as 7.5 mL liquid oil providing 1500 IU vitamin D3 + 1125 mg EPA + 750 mg DHA, to be ingested once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTR</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control will ingest an isocaloric placebo consisting of 1) 30 g maltodextrin, twice daily, following the same schedule, and 2) 7.5 mL corn oil, once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Multi-nutrient supplement</intervention_name>
    <arm_group_label>EXP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>CTR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  participants of Geriatric Day Hospital programs&#xD;
&#xD;
          -  able to understand study requirements (Mini Mental State Exam, MMSE &gt;22/30)&#xD;
&#xD;
          -  able to read and speak English or French&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt;35 kg/m2&#xD;
&#xD;
          -  glomerular filtration rate &lt;30 mL/min/SA),&#xD;
&#xD;
          -  liver or heart failure,&#xD;
&#xD;
          -  stroke in the last 6 months (unless totally recovered),&#xD;
&#xD;
          -  Parkinson's disease or severe neurologic conditions,&#xD;
&#xD;
          -  active malignancies,&#xD;
&#xD;
          -  acute inflammation (CRP &gt;10 mg/L),&#xD;
&#xD;
          -  known diagnostic of hyperparathyroidism,&#xD;
&#xD;
          -  recent acute weight loss (&gt;10% in 3 months, unless stabilized),&#xD;
&#xD;
          -  allergy to milk and/or fish,&#xD;
&#xD;
          -  long-term use of corticosteroids or anti-neoplastic medication&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Stéphanie Chevalier, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Institute of the McGill University Health Centre</affiliation>
  </overall_official>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University</investigator_affiliation>
    <investigator_full_name>Stéphanie Chevalier</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>nutritional supplement</keyword>
  <keyword>loss of autonomy</keyword>
  <keyword>rehabilitation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD sharing was not planned originally and therefore consent was not obtained for it.</ipd_description>
  </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/NCT04454359
org study id: 15-633-MUHC
nct id: NCT04454359
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Geriatric Day Hospitals (GDH) of the McGill University Health Centre and l'Institut de
      Gériatrie de Montreal offer comprehensive rehabilitation programs including physiotherapy and
      medical care, but no dietetic counselling for the attending frail population at high risk of
      malnutrition. This study aims to implement a multi-nutrient supplement to further improve
      nutritional status, physical function and capacity. A whey protein, leucine, vitamin D and
      omega-3 fatty acid supplement ingested during 16 weeks will be tested versus an isocaloric
      placebo on measures of physical performance and muscle mass and strength, in GDH
      participants. The specific objective of this pilot-study is to test feasibility and
      adherence; pilot data could lead to a larger trial.
RATIONALE Given the high prevalence of malnutrition of the GDH participants and its impact on
      poor physical performance, providing a nutritional supplement to increase protein, leucine,
      vitamin D and omega-3 FA intake should complement and optimize the rehabilitation
      interventions in improving muscle mass, strength and physical performance.

      OBJECTIVES

      Implementing the proposed nutritional supplement in the routine care of GDH participants
      will:

        1. test the feasibility, acceptance and adherence to the supplement and its safety

        2. provide pilot data to test the superiority of the supplement versus an isocaloric
           placebo on measures of muscle mass, strength, and physical performance.

      STUDY DESIGN. This is a randomized, placebo-controlled, double-blinded trial of two parallel
      arms, conducted on two sites. Eligible participants will be randomly assigned to one of two
      groups: experimental (EXP) or control (CTR) in a 1:1 ratio. Randomization will be achieved by
      computer-generated permuted block of four.

      INTERVENTION The EXP arm will ingest a multi-nutrient supplement consisting of whey protein +
      leucine and fish oil + vitamin D and CTR arm will ingest an isocaloric plabebo, during 16
      weeks (about 8 weeks during rehabilitation and 8 more weeks after). Outcome assessment will
      be performed at baseline, week 8 and week 16, except for body composition measured by DXA at
      baseline and week 16.

      OUTCOMES Primary: feasibility Secondary: physical performance, muscle strength, appendicular
      lean mass Other: dietary intake, physical activity, clinical markers

      STATISTICAL ANALYSIS This pilot study is designed to generate data on feasibility, acceptance
      and compliance to the supplement and is not powered for identifying statistical differences
      in the secondary outcomes. A sample size of n=40 (20/group) is planned to test feasibility.
      Data will be reported as medians and 95% CI.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, placebo-controlled, double-blinded pilot trial
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Isocaloric placebos of same taste and texture as the experimental supplements
measure: Feasibility: recruitment rate
time frame: Recruitment over 2 years
description: Recruitment rate (measured in %, compared to expected rates)
measure: Feasibility: adherence to intervention
time frame: Over 16 weeks
description: Adherence to supplements (measured in %, compared to expected rates)
measure: Feasibility: completion
time frame: Over 16 weeks
description: Completion of study outcome assessments (measured in %, compared to expected rates)
measure: 6-minute walking test
time frame: Weeks 0, 8 and 16
description: 6-minute walking test (measured as the distance walked during 6 minutes, along a 30-m corridor, expressed in m)
measure: Chair stand test
time frame: Weeks 0, 8 and 16
description: 30-second chair stand test: measured as the number of stands from a chair without arms, in 30 sec)
measure: Timed-up-and-go test
time frame: Weeks 0, 8 and 16
description: Timed-up-and-go (time to get up from a chair without armrest, walk 3 m and return to sit down completely on the chair, measured in seconds)
measure: Handgrip strength
time frame: Weeks 0, 8 and 16
description: Maximal handgrip strength (using hand-held Jamar dynamometer, measured in kg),
measure: Leg strength
time frame: Weeks 0, 8 and 16
description: Isometric knee extension peak torque (using Biodex, measured in N)
measure: Appendicular lean mass
time frame: Weeks 0 and 16
description: Sum of soft lean mass from arms and legs (measured by iDXA, in kg)
measure: Protein intake
time frame: Weeks 0, 8 and 16
description: Protein intake (g) from foods and supplements, estimated from 3-day food diary (using Food Processor with Canadian Nutrient File)
measure: Step counts
time frame: Weeks 0, 8 and 16
description: Measured by accelerometry during 4 days (Actigraph)
measure: Serum albumin
time frame: Weeks 0, 8 and 16
description: Albumin, in g/L (measured by the MUHC biochemical laboratory)
measure: Serum pre-albumin
time frame: Weeks 0, 8 and 16
description: Pre-albumin, in mg/L (measured by the MUHC biochemical laboratory)
measure: Serum C-reactive Protein
time frame: Weeks 0, 8 and 16
description: CRP, in mg/L (measured by the MUHC biochemical laboratory)
measure: Serum Vitamin D
time frame: Weeks 0, 8 and 16
description: Vitamin D status, 25(OH)D, in nmol/L (measured by the MUHC biochemical laboratory)
measure: Plasma glucose
time frame: Weeks 0, 8 and 16
description: Glucose, in mmol/L (measured with glucose oxidase method)
measure: Serum IGF-1
time frame: Weeks 0, 8 and 16
description: IGF-1, in ng/mL (measured by ELISA)
measure: Plasma phospholipid omega-3 fatty acids
time frame: Weeks 0, 8 and 16
description: EPA and DHA, expressed as a proportion (%) over total; used as an objective measure of adherence to fish oil supplement (measured by gas chromatography-flame ionization)
measure: Energy intake
time frame: Weeks 0, 8 and 16
description: energy intake (kcal) from average of 3-day food diary (using Food Processor with Canadian Nutrient File)
arm group label: EXP
arm group type: Experimental
description: EXP group will ingest a supplement consisting of 1) flavored whey protein isolate with added pure leucine (3 g) diluted in water, twice daily, before breakfast and before bedtime; doses are adjusted per body weight as follows: 20 g, 25 g or 30 g per category of <65 kg, 65-75 kg and >75 kg of body weight respectively. 2) fish oil containing vitamin D, provided as 7.5 mL liquid oil providing 1500 IU vitamin D3 + 1125 mg EPA + 750 mg DHA, to be ingested once daily.
arm group label: CTR
arm group type: Placebo Comparator
description: Control will ingest an isocaloric placebo consisting of 1) 30 g maltodextrin, twice daily, following the same schedule, and 2) 7.5 mL corn oil, once daily.
intervention type: Dietary Supplement
intervention name: Multi-nutrient supplement
arm group label: EXP
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: CTR
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Stéphanie Chevalier, PhD
role: Principal Investigator
affiliation: Research Institute of the McGill University Health Centre
responsible party type: Principal Investigator
investigator affiliation: McGill University
investigator full name: Stéphanie Chevalier
investigator title: Associate Professor
sharing ipd: No
ipd description: IPD sharing was not planned originally and therefore consent was not obtained for it.