<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/NCT03786835</url>
  </required_header>
  <id_info>
    <org_study_id>2018/01183</org_study_id>
    <nct_id>NCT03786835</nct_id>
  </id_info>
  <brief_title>Healthy Older People Everyday (HOPE) - Role of Healthy Diet on Muscle and Bone Health</brief_title>
  <acronym>HOPE-DIET</acronym>
  <official_title>Healthy Older People Everyday (HOPE) - Role of Healthy Diet on Muscle and Bone Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Health Promotion Board (HPB)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Saw Swee Hock Shool of Public Health, National University of Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National University Hospital, Singapore</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>
      Certain clinical syndromes eg frailty, sarcopenia, dementia, depression, cognitive&#xD;
      impairment, vision impairment and falls in older adults carry an increased risk for poor&#xD;
      health outcomes and if identified early, can be prevented, delayed or reversible. There is&#xD;
      evidence to suggest that exercise and dietary intervention can help delay or prevent&#xD;
      sarcopenia, frailty and dementia.&#xD;
&#xD;
      The current hypothesis is older adults do not consume enough protein in their diet. Local&#xD;
      delicacies enhanced with protein content, in addition to physical activity will improve&#xD;
      muscle strength, function, perceived health status and possibly may even reverse frailty and&#xD;
      sarcopenia. Additionally, it is hypothesized that combination of multi component group&#xD;
      exercise activities and high protein nutrition will be effective in improving participants'&#xD;
      social, mental and physical status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      From our own published local data, the prevalence of pre-frailty in North-West area is 37%&#xD;
      and frailty 6.2%. Prevalence of frailty in individuals with diabetes is 12%, double that of&#xD;
      general population.&#xD;
&#xD;
      Evidence suggest that multi-component intervention may delay the onset of disability, and in&#xD;
      some cases reverse frailty with the potential to avert preventable adverse events such as&#xD;
      falls, fractures and reduce overall healthcare utilisation and extend health-span. There is a&#xD;
      similar multi-centre trial in progress in Europe called SPRINTT. As physical exercise and&#xD;
      adequate protein and energy intake are to date the only strategies of proven efficacy to&#xD;
      improve muscle health, it is important that we develop locally relevant protein enriched food&#xD;
      prototypes that can deliver an effective dosage of protein to the older adult and compare&#xD;
      them with available protein enriched supplements. High protein diet stimulates muscle protein&#xD;
      synthesis and plays a role in delaying the onset of frailty and sarcopenia. An adequate&#xD;
      intake of dietary proteins is vital to maintaining muscle mass and stimulating protein&#xD;
      synthesis. Older adults are at high risk for insufficient protein intake and furthermore, the&#xD;
      current recommended dietary allowance for protein (0.8 g/kg/day) might not be sufficient for&#xD;
      preserving muscle mass and quality in old age. It appears therefore appropriate to promote a&#xD;
      protein intake of 1.0-1.2 g/kg/day, while 1.2-1.5 g/kg/day of protein may be required in&#xD;
      older adults with acute or chronic diseases. Finally, older people with severe illnesses or&#xD;
      overt malnutrition may need as much as 2.0 g/kg/day of protein. In addition to protein, the&#xD;
      PROVIDE study also showed that sufficient levels of vitamin D and protein is necessary to&#xD;
      increase muscle mass and reduce sarcopenia. While most middle aged adults and older adults&#xD;
      attempt to keep up with physical activity, very few actually are aware of importance of&#xD;
      protein and Vitamin D enriched diet. Exercise and increased protein intake can also&#xD;
      down-regulate systemic inflammation.&#xD;
&#xD;
      Locally, there's one small study (n=49 for nutrition and n=49 combined intervention) which&#xD;
      documented reversal of frailty with multicomponent intervention, where the nutrition&#xD;
      component was a commercial formula Fortisip (Nutricia Dublin). Up to now, there are no&#xD;
      locally developed high protein supplements and we have no data on average protein content of&#xD;
      local diet consumption in older adults. If locally produced, culturally-relevant high protein&#xD;
      food prototype is widely accepted and is proven to improve function and quality of life, it&#xD;
      will be an innovative solution to solving nutritional gaps and delivering an effective dose&#xD;
      of protein to the elderly population in Singapore. This can especially help the elderly&#xD;
      population receive protein supplementation not through commercially produced expensive&#xD;
      supplements but through the foods and drinks that they consume everyday. These prototypes can&#xD;
      also help the local food and beverage industry recognize the importance and value of&#xD;
      investing resources into the continued development of these products to better address local&#xD;
      public health needs and possibly export these products to the wider region's ageing&#xD;
      population.&#xD;
&#xD;
      In addition, the results from this study will provide the basis and baseline for a review of&#xD;
      the current recommended dietary allowance for protein, especially among older adults. The&#xD;
      current recommendation of 0.8 g of protein/kg/day was based on the maintenance of a healthy&#xD;
      adult's nitrogen balance. It would be important to formulate a set of recommendation to meet&#xD;
      the functional and physiological needs of the elderly.&#xD;
&#xD;
      This programme will be the nutritional arm of a current study called 'HAPPY' Healthy Ageing&#xD;
      Promotion Program For You, where participants are screened for frailty in the day care,&#xD;
      senior activity centre's and community centre's. Participants with cognitive impairment and /&#xD;
      or pre-frail are invited to participate in dual task exercise led by trainer from Japan. This&#xD;
      locally produced high protein food will be trialled in these participants who have been&#xD;
      identified during screening for &quot;HAPPY&quot;. Informed consent will be obtained from participants&#xD;
      to participate in the HAPPY and HOPE programmes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in frailty status</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in frailty status by 5-item FRAIL scale Scale range from 0 to 5, the higher the value, the more frail.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in lower extremity physical performance</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in short physical performance battery (SPPB) summary score 3 subscales (range from 0 to 4 for balance, gait speed and chair stand) summed to give total score range from 0 to 12.&#xD;
The higher the value, the better the performance of lower extremity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in upper extremity muscle strength</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in handgrip strength test performance (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in skeletal muscle mass</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in skeletal muscle mass by bioelectrical impedance analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in sarcopenic status</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in sarcopenic status by SARC-F scale Scale range from 0 to 10, the higher the value, the greater the likelihood of sarcopenic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in mood</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in Geriatric Depression Scale (GDS) Scale range from 0 to 15, the higher the score, the greater the likelihood of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in mood</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in UCLA Loneliness Scale Scale range from 0 to 9, the higher the value, the greater the loneliness Scale from 0 to</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cognitive function</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in Mini Mental State Examination (MMSE) score 5 subscales: Orientation (0 to 10), Registration (0 to 3), Attention and Calculation (0 to 5), Recall (0 to 3), Language and Praxis (0 to 9) Total scale range from 0 to 30, the higher the value, the less cognitive impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cognitive function</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in Montreal Cognitive Assessment (MoCA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in nutritional status</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in Mini Nutritional Assessment (MNA) score 2 Subscales: Screening (0 to 14) and Assessment (0 to 16) Total scale range from 0 to 30, the higher the value, the more well nourished.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in functional status (instrumental activities of daily living)</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in Instrumental Activities of Daily Living (IADL) score Scale range from 0 to 8, the higher the value, the greater the ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in functional status (activities of daily living)</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in Activities of Daily Living (ADL) score Scale range from 0 to 6, the higher the value, the greater the ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fall risk</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in fall efficacy questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of self-reported falls</measure>
    <time_frame>2 years</time_frame>
    <description>Number of falls assessed by questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in EuroQoL-5D (EQ5D) score 5 subscales (1 to 5): Mobility, self-care, usual activities, pain/discomfort, anxiety/depressed Each subscale assessed individually.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in social engagement</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in Lubben Social Network Scale. Scale range from 0 to 30, the higher the value, the greater the social engagement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in systemic inflammation</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in Tumour necrosis factor alpha (TNF-a)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in systemic inflammation</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in Interleukin-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in systemic inflammation</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in Interleukin-6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in phase angle by bioelectrical impedance analysis</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in phase angle by bioelectrical impedance analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in protein mass</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in protein mass by bioelectrical impedance analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in level of bone biomarkers</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in level of serum sclerotin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in level of bone biomarkers</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in level of serum osteocalcin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in level of bone biomarkers</measure>
    <time_frame>2 years</time_frame>
    <description>Changes in level of free Vitamin D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance of protein enriched food by local seniors</measure>
    <time_frame>2 years</time_frame>
    <description>Assessed by taste test questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness analysis</measure>
    <time_frame>2 years</time_frame>
    <description>Cost effectiveness will be evaluated from the societal perspective. Cost of the program as well as healthcare utilization related to frailty and sarcopenia will be collected. An incremental cost effectiveness ratio will be computed by identifying the additional costs associated with the Intervention Group per additional unit of health outcome (QALYs).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Muscle Weakness</condition>
  <condition>Bone Health</condition>
  <condition>Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>Control (No intervention)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will not undergo any treatment. Continue with usual daily activities and diet for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutrition group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive protein enriched food to supplement the diet for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will exercise 3 times a week for 60 minutes each time over 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutrition + Exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive protein enriched food to supplement the diet and exercise 3 times a week for 60 minutes each time over 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Protein supplementation and regular physical activity</intervention_name>
    <description>To determine if high protein diet and/or regular physical activity improves muscle and bone health</description>
    <arm_group_label>Exercise group</arm_group_label>
    <arm_group_label>Nutrition + Exercise group</arm_group_label>
    <arm_group_label>Nutrition group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least pre-frail (Frail scale score of at least 1) but ambulant&#xD;
&#xD;
          -  Grip strength not more than 25kg for males and 18kg for females&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With kidney conditions&#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>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National University Hospital, Singapore</investigator_affiliation>
    <investigator_full_name>Medicine</investigator_full_name>
    <investigator_title>Head &amp; Senior Consultant, Division of Geriatric Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03786835
org study id: 2018/01183
nct id: NCT03786835
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Certain clinical syndromes eg frailty, sarcopenia, dementia, depression, cognitive
      impairment, vision impairment and falls in older adults carry an increased risk for poor
      health outcomes and if identified early, can be prevented, delayed or reversible. There is
      evidence to suggest that exercise and dietary intervention can help delay or prevent
      sarcopenia, frailty and dementia.

      The current hypothesis is older adults do not consume enough protein in their diet. Local
      delicacies enhanced with protein content, in addition to physical activity will improve
      muscle strength, function, perceived health status and possibly may even reverse frailty and
      sarcopenia. Additionally, it is hypothesized that combination of multi component group
      exercise activities and high protein nutrition will be effective in improving participants'
      social, mental and physical status.
From our own published local data, the prevalence of pre-frailty in North-West area is 37%
      and frailty 6.2%. Prevalence of frailty in individuals with diabetes is 12%, double that of
      general population.

      Evidence suggest that multi-component intervention may delay the onset of disability, and in
      some cases reverse frailty with the potential to avert preventable adverse events such as
      falls, fractures and reduce overall healthcare utilisation and extend health-span. There is a
      similar multi-centre trial in progress in Europe called SPRINTT. As physical exercise and
      adequate protein and energy intake are to date the only strategies of proven efficacy to
      improve muscle health, it is important that we develop locally relevant protein enriched food
      prototypes that can deliver an effective dosage of protein to the older adult and compare
      them with available protein enriched supplements. High protein diet stimulates muscle protein
      synthesis and plays a role in delaying the onset of frailty and sarcopenia. An adequate
      intake of dietary proteins is vital to maintaining muscle mass and stimulating protein
      synthesis. Older adults are at high risk for insufficient protein intake and furthermore, the
      current recommended dietary allowance for protein (0.8 g/kg/day) might not be sufficient for
      preserving muscle mass and quality in old age. It appears therefore appropriate to promote a
      protein intake of 1.0-1.2 g/kg/day, while 1.2-1.5 g/kg/day of protein may be required in
      older adults with acute or chronic diseases. Finally, older people with severe illnesses or
      overt malnutrition may need as much as 2.0 g/kg/day of protein. In addition to protein, the
      PROVIDE study also showed that sufficient levels of vitamin D and protein is necessary to
      increase muscle mass and reduce sarcopenia. While most middle aged adults and older adults
      attempt to keep up with physical activity, very few actually are aware of importance of
      protein and Vitamin D enriched diet. Exercise and increased protein intake can also
      down-regulate systemic inflammation.

      Locally, there's one small study (n=49 for nutrition and n=49 combined intervention) which
      documented reversal of frailty with multicomponent intervention, where the nutrition
      component was a commercial formula Fortisip (Nutricia Dublin). Up to now, there are no
      locally developed high protein supplements and we have no data on average protein content of
      local diet consumption in older adults. If locally produced, culturally-relevant high protein
      food prototype is widely accepted and is proven to improve function and quality of life, it
      will be an innovative solution to solving nutritional gaps and delivering an effective dose
      of protein to the elderly population in Singapore. This can especially help the elderly
      population receive protein supplementation not through commercially produced expensive
      supplements but through the foods and drinks that they consume everyday. These prototypes can
      also help the local food and beverage industry recognize the importance and value of
      investing resources into the continued development of these products to better address local
      public health needs and possibly export these products to the wider region's ageing
      population.

      In addition, the results from this study will provide the basis and baseline for a review of
      the current recommended dietary allowance for protein, especially among older adults. The
      current recommendation of 0.8 g of protein/kg/day was based on the maintenance of a healthy
      adult's nitrogen balance. It would be important to formulate a set of recommendation to meet
      the functional and physiological needs of the elderly.

      This programme will be the nutritional arm of a current study called 'HAPPY' Healthy Ageing
      Promotion Program For You, where participants are screened for frailty in the day care,
      senior activity centre's and community centre's. Participants with cognitive impairment and /
      or pre-frail are invited to participate in dual task exercise led by trainer from Japan. This
      locally produced high protein food will be trialled in these participants who have been
      identified during screening for "HAPPY". Informed consent will be obtained from participants
      to participate in the HAPPY and HOPE programmes.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Changes in frailty status
time frame: 2 years
description: Changes in frailty status by 5-item FRAIL scale Scale range from 0 to 5, the higher the value, the more frail.
measure: Changes in lower extremity physical performance
time frame: 2 years
description: Changes in short physical performance battery (SPPB) summary score 3 subscales (range from 0 to 4 for balance, gait speed and chair stand) summed to give total score range from 0 to 12.
The higher the value, the better the performance of lower extremity.
measure: Changes in upper extremity muscle strength
time frame: 2 years
description: Changes in handgrip strength test performance (kg)
measure: Changes in skeletal muscle mass
time frame: 2 years
description: Changes in skeletal muscle mass by bioelectrical impedance analysis
measure: Changes in sarcopenic status
time frame: 2 years
description: Changes in sarcopenic status by SARC-F scale Scale range from 0 to 10, the higher the value, the greater the likelihood of sarcopenic
measure: Changes in mood
time frame: 2 years
description: Changes in Geriatric Depression Scale (GDS) Scale range from 0 to 15, the higher the score, the greater the likelihood of depression.
measure: Changes in mood
time frame: 2 years
description: Changes in UCLA Loneliness Scale Scale range from 0 to 9, the higher the value, the greater the loneliness Scale from 0 to
measure: Changes in cognitive function
time frame: 2 years
description: Changes in Mini Mental State Examination (MMSE) score 5 subscales: Orientation (0 to 10), Registration (0 to 3), Attention and Calculation (0 to 5), Recall (0 to 3), Language and Praxis (0 to 9) Total scale range from 0 to 30, the higher the value, the less cognitive impairment.
measure: Changes in cognitive function
time frame: 2 years
description: Changes in Montreal Cognitive Assessment (MoCA)
measure: Changes in nutritional status
time frame: 2 years
description: Changes in Mini Nutritional Assessment (MNA) score 2 Subscales: Screening (0 to 14) and Assessment (0 to 16) Total scale range from 0 to 30, the higher the value, the more well nourished.
measure: Changes in functional status (instrumental activities of daily living)
time frame: 2 years
description: Changes in Instrumental Activities of Daily Living (IADL) score Scale range from 0 to 8, the higher the value, the greater the ability.
measure: Changes in functional status (activities of daily living)
time frame: 2 years
description: Changes in Activities of Daily Living (ADL) score Scale range from 0 to 6, the higher the value, the greater the ability.
measure: Changes in fall risk
time frame: 2 years
description: Changes in fall efficacy questionnaire
measure: Incidence of self-reported falls
time frame: 2 years
description: Number of falls assessed by questionnaires
measure: Changes in quality of life
time frame: 2 years
description: Changes in EuroQoL-5D (EQ5D) score 5 subscales (1 to 5): Mobility, self-care, usual activities, pain/discomfort, anxiety/depressed Each subscale assessed individually.
measure: Changes in social engagement
time frame: 2 years
description: Changes in Lubben Social Network Scale. Scale range from 0 to 30, the higher the value, the greater the social engagement
measure: Changes in systemic inflammation
time frame: 2 years
description: Changes in Tumour necrosis factor alpha (TNF-a)
measure: Changes in systemic inflammation
time frame: 2 years
description: Changes in Interleukin-10
measure: Changes in systemic inflammation
time frame: 2 years
description: Changes in Interleukin-6
measure: Changes in phase angle by bioelectrical impedance analysis
time frame: 2 years
description: Changes in phase angle by bioelectrical impedance analysis
measure: Changes in protein mass
time frame: 2 years
description: Changes in protein mass by bioelectrical impedance analysis
measure: Changes in level of bone biomarkers
time frame: 2 years
description: Changes in level of serum sclerotin
measure: Changes in level of bone biomarkers
time frame: 2 years
description: Changes in level of serum osteocalcin
measure: Changes in level of bone biomarkers
time frame: 2 years
description: Changes in level of free Vitamin D
measure: Acceptance of protein enriched food by local seniors
time frame: 2 years
description: Assessed by taste test questionnaire
measure: Cost-effectiveness analysis
time frame: 2 years
description: Cost effectiveness will be evaluated from the societal perspective. Cost of the program as well as healthcare utilization related to frailty and sarcopenia will be collected. An incremental cost effectiveness ratio will be computed by identifying the additional costs associated with the Intervention Group per additional unit of health outcome (QALYs).
arm group label: Control (No intervention)
arm group type: No Intervention
description: Participants will not undergo any treatment. Continue with usual daily activities and diet for 6 months.
arm group label: Nutrition group
arm group type: Experimental
description: Participants will receive protein enriched food to supplement the diet for 6 months.
arm group label: Exercise group
arm group type: Experimental
description: Participants will exercise 3 times a week for 60 minutes each time over 6 months.
arm group label: Nutrition + Exercise group
arm group type: Experimental
description: Participants will receive protein enriched food to supplement the diet and exercise 3 times a week for 60 minutes each time over 6 months.
intervention type: Other
intervention name: Protein supplementation and regular physical activity
description: To determine if high protein diet and/or regular physical activity improves muscle and bone health
arm group label: Exercise group
arm group label: Nutrition + Exercise group
arm group label: Nutrition group
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: National University Hospital, Singapore
investigator full name: Medicine
investigator title: Head & Senior Consultant, Division of Geriatric Medicine
mesh term: Muscle Weakness
mesh term: Cognitive Dysfunction
sharing ipd: Undecided