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
About this trial
This is an interventional prevention trial for Muscle Weakness
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
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
NCT ID
NCT03786835
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
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
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