search
Back to results

Healthy Older People Everyday (HOPE) - Role of Healthy Diet on Muscle and Bone Health (HOPE-DIET)

Primary Purpose

Muscle Weakness, Bone Health, Cognitive Decline

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Protein supplementation and regular physical activity
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Muscle Weakness

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • At least pre-frail (Frail scale score of at least 1) but ambulant
  • Grip strength not more than 25kg for males and 18kg for females

Exclusion Criteria:

  • With kidney conditions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    Control (No intervention)

    Nutrition group

    Exercise group

    Nutrition + Exercise group

    Arm Description

    Participants will not undergo any treatment. Continue with usual daily activities and diet for 6 months.

    Participants will receive protein enriched food to supplement the diet for 6 months.

    Participants will exercise 3 times a week for 60 minutes each time over 6 months.

    Participants will receive protein enriched food to supplement the diet and exercise 3 times a week for 60 minutes each time over 6 months.

    Outcomes

    Primary Outcome Measures

    Changes in frailty status
    Changes in frailty status by 5-item FRAIL scale Scale range from 0 to 5, the higher the value, the more frail.
    Changes in lower extremity physical performance
    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.

    Secondary Outcome Measures

    Changes in upper extremity muscle strength
    Changes in handgrip strength test performance (kg)
    Changes in skeletal muscle mass
    Changes in skeletal muscle mass by bioelectrical impedance analysis
    Changes in sarcopenic status
    Changes in sarcopenic status by SARC-F scale Scale range from 0 to 10, the higher the value, the greater the likelihood of sarcopenic
    Changes in mood
    Changes in Geriatric Depression Scale (GDS) Scale range from 0 to 15, the higher the score, the greater the likelihood of depression.
    Changes in mood
    Changes in UCLA Loneliness Scale Scale range from 0 to 9, the higher the value, the greater the loneliness Scale from 0 to
    Changes in cognitive function
    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.
    Changes in cognitive function
    Changes in Montreal Cognitive Assessment (MoCA)
    Changes in nutritional status
    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.
    Changes in functional status (instrumental activities of daily living)
    Changes in Instrumental Activities of Daily Living (IADL) score Scale range from 0 to 8, the higher the value, the greater the ability.
    Changes in functional status (activities of daily living)
    Changes in Activities of Daily Living (ADL) score Scale range from 0 to 6, the higher the value, the greater the ability.
    Changes in fall risk
    Changes in fall efficacy questionnaire
    Incidence of self-reported falls
    Number of falls assessed by questionnaires
    Changes in quality of life
    Changes in EuroQoL-5D (EQ5D) score 5 subscales (1 to 5): Mobility, self-care, usual activities, pain/discomfort, anxiety/depressed Each subscale assessed individually.
    Changes in social engagement
    Changes in Lubben Social Network Scale. Scale range from 0 to 30, the higher the value, the greater the social engagement
    Changes in systemic inflammation
    Changes in Tumour necrosis factor alpha (TNF-a)
    Changes in systemic inflammation
    Changes in Interleukin-10
    Changes in systemic inflammation
    Changes in Interleukin-6
    Changes in phase angle by bioelectrical impedance analysis
    Changes in phase angle by bioelectrical impedance analysis
    Changes in protein mass
    Changes in protein mass by bioelectrical impedance analysis
    Changes in level of bone biomarkers
    Changes in level of serum sclerotin
    Changes in level of bone biomarkers
    Changes in level of serum osteocalcin
    Changes in level of bone biomarkers
    Changes in level of free Vitamin D
    Acceptance of protein enriched food by local seniors
    Assessed by taste test questionnaire
    Cost-effectiveness analysis
    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).

    Full Information

    First Posted
    December 11, 2018
    Last Updated
    December 20, 2018
    Sponsor
    National University Hospital, Singapore
    Collaborators
    Health Promotion Board (HPB), Saw Swee Hock Shool of Public Health, National University of Singapore
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03786835
    Brief Title
    Healthy Older People Everyday (HOPE) - Role of Healthy Diet on Muscle and Bone Health
    Acronym
    HOPE-DIET
    Official Title
    Healthy Older People Everyday (HOPE) - Role of Healthy Diet on Muscle and Bone Health
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2019 (Anticipated)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National University Hospital, Singapore
    Collaborators
    Health Promotion Board (HPB), Saw Swee Hock Shool of Public Health, National University of Singapore

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Muscle Weakness, Bone Health, Cognitive Decline

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control (No intervention)
    Arm Type
    No Intervention
    Arm Description
    Participants will not undergo any treatment. Continue with usual daily activities and diet for 6 months.
    Arm Title
    Nutrition group
    Arm Type
    Experimental
    Arm Description
    Participants will receive protein enriched food to supplement the diet for 6 months.
    Arm Title
    Exercise group
    Arm Type
    Experimental
    Arm Description
    Participants will exercise 3 times a week for 60 minutes each time over 6 months.
    Arm Title
    Nutrition + Exercise group
    Arm Type
    Experimental
    Arm 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(s)
    Protein supplementation and regular physical activity
    Intervention Description
    To determine if high protein diet and/or regular physical activity improves muscle and bone health
    Primary Outcome Measure Information:
    Title
    Changes in frailty status
    Description
    Changes in frailty status by 5-item FRAIL scale Scale range from 0 to 5, the higher the value, the more frail.
    Time Frame
    2 years
    Title
    Changes in lower extremity physical performance
    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.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Changes in upper extremity muscle strength
    Description
    Changes in handgrip strength test performance (kg)
    Time Frame
    2 years
    Title
    Changes in skeletal muscle mass
    Description
    Changes in skeletal muscle mass by bioelectrical impedance analysis
    Time Frame
    2 years
    Title
    Changes in sarcopenic status
    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
    Time Frame
    2 years
    Title
    Changes in mood
    Description
    Changes in Geriatric Depression Scale (GDS) Scale range from 0 to 15, the higher the score, the greater the likelihood of depression.
    Time Frame
    2 years
    Title
    Changes in mood
    Description
    Changes in UCLA Loneliness Scale Scale range from 0 to 9, the higher the value, the greater the loneliness Scale from 0 to
    Time Frame
    2 years
    Title
    Changes in cognitive function
    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.
    Time Frame
    2 years
    Title
    Changes in cognitive function
    Description
    Changes in Montreal Cognitive Assessment (MoCA)
    Time Frame
    2 years
    Title
    Changes in nutritional status
    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.
    Time Frame
    2 years
    Title
    Changes in functional status (instrumental activities of daily living)
    Description
    Changes in Instrumental Activities of Daily Living (IADL) score Scale range from 0 to 8, the higher the value, the greater the ability.
    Time Frame
    2 years
    Title
    Changes in functional status (activities of daily living)
    Description
    Changes in Activities of Daily Living (ADL) score Scale range from 0 to 6, the higher the value, the greater the ability.
    Time Frame
    2 years
    Title
    Changes in fall risk
    Description
    Changes in fall efficacy questionnaire
    Time Frame
    2 years
    Title
    Incidence of self-reported falls
    Description
    Number of falls assessed by questionnaires
    Time Frame
    2 years
    Title
    Changes in quality of life
    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.
    Time Frame
    2 years
    Title
    Changes in social engagement
    Description
    Changes in Lubben Social Network Scale. Scale range from 0 to 30, the higher the value, the greater the social engagement
    Time Frame
    2 years
    Title
    Changes in systemic inflammation
    Description
    Changes in Tumour necrosis factor alpha (TNF-a)
    Time Frame
    2 years
    Title
    Changes in systemic inflammation
    Description
    Changes in Interleukin-10
    Time Frame
    2 years
    Title
    Changes in systemic inflammation
    Description
    Changes in Interleukin-6
    Time Frame
    2 years
    Title
    Changes in phase angle by bioelectrical impedance analysis
    Description
    Changes in phase angle by bioelectrical impedance analysis
    Time Frame
    2 years
    Title
    Changes in protein mass
    Description
    Changes in protein mass by bioelectrical impedance analysis
    Time Frame
    2 years
    Title
    Changes in level of bone biomarkers
    Description
    Changes in level of serum sclerotin
    Time Frame
    2 years
    Title
    Changes in level of bone biomarkers
    Description
    Changes in level of serum osteocalcin
    Time Frame
    2 years
    Title
    Changes in level of bone biomarkers
    Description
    Changes in level of free Vitamin D
    Time Frame
    2 years
    Title
    Acceptance of protein enriched food by local seniors
    Description
    Assessed by taste test questionnaire
    Time Frame
    2 years
    Title
    Cost-effectiveness analysis
    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).
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: At least pre-frail (Frail scale score of at least 1) but ambulant Grip strength not more than 25kg for males and 18kg for females Exclusion Criteria: With kidney conditions

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Healthy Older People Everyday (HOPE) - Role of Healthy Diet on Muscle and Bone Health

    We'll reach out to this number within 24 hrs