Muscle WeaknessHOPE-DIETNCT03786835
Healthy Older People Everyday (HOPE) - Role of Healthy Diet on Muscle and Bone Health
A study testing Protein supplementation and regular physical activity in people with Muscle Weakness and Bone Health, run by National University Hospital, Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness, Bone Health, Cognitive Decline
- What is being tested?
- Protein supplementation and regular physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- With kidney conditions
About this study
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.
Read the 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.
- Conditions
- Muscle Weakness, Bone Health, Cognitive Decline
- Being tested
- Protein supplementation and regular physical activity
- Medical subject headings
- Muscle Weakness, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein supplementation and regular physical activityOther
To determine if high protein diet and/or regular physical activity improves muscle and bone health
| Study group | Role | What they receive |
|---|---|---|
| Control (No intervention) | No intervention | Participants will not undergo any treatment. Continue with usual daily activities and diet for 6 months. |
| Nutrition group | Experimental | Participants will receive protein enriched food to supplement the diet for 6 months. Receives: Other: Protein supplementation and regular physical activity |
| Exercise group | Experimental | Participants will exercise 3 times a week for 60 minutes each time over 6 months. Receives: Other: Protein supplementation and regular physical activity |
| Nutrition + Exercise group | Experimental | Participants will receive protein enriched food to supplement the diet and exercise 3 times a week for 60 minutes each time over 6 months. Receives: Other: Protein supplementation and regular physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
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.
Measured: 2 years
Secondary outcomes (24)
Changes in upper extremity muscle strength
Changes in handgrip strength test performance (kg)
Measured: 2 years
Changes in skeletal muscle mass
Changes in skeletal muscle mass by bioelectrical impedance analysis
Measured: 2 years
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
Measured: 2 years
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.
Measured: 2 years
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
Measured: 2 years
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.
Measured: 2 years
Changes in cognitive function
Changes in Montreal Cognitive Assessment (MoCA)
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Changes in fall risk
Changes in fall efficacy questionnaire
Measured: 2 years
Incidence of self-reported falls
Number of falls assessed by questionnaires
Measured: 2 years
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.
Measured: 2 years
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
Measured: 2 years
Changes in systemic inflammation
Changes in Tumour necrosis factor alpha (TNF-a)
Measured: 2 years
Changes in systemic inflammation
Changes in Interleukin-10
Measured: 2 years
Changes in systemic inflammation
Changes in Interleukin-6
Measured: 2 years
Changes in phase angle by bioelectrical impedance analysis
Changes in phase angle by bioelectrical impedance analysis
Measured: 2 years
Changes in protein mass
Changes in protein mass by bioelectrical impedance analysis
Measured: 2 years
Changes in level of bone biomarkers
Changes in level of serum sclerotin
Measured: 2 years
Changes in level of bone biomarkers
Changes in level of serum osteocalcin
Measured: 2 years
Changes in level of bone biomarkers
Changes in level of free Vitamin D
Measured: 2 years
Acceptance of protein enriched food by local seniors
Assessed by taste test questionnaire
Measured: 2 years
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study startJan 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Health Promotion Board (HPB), Saw Swee Hock Shool of Public Health, National University of Singapore
- Responsible party
- Principal investigator, Medicine, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786835
- Sponsor's protocol ID
- 2018/01183
- Other IDs
- 2018
- Acronym
- HOPE-DIET
- Status last verified
- Dec 2018
- First submitted
- 11 Dec 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Older People Everyday (HOPE) - Role of Healthy Diet on Muscle and Bone Health
- ClinicalTrials.gov ID
- NCT03786835
- Acronym / sponsor ID
- HOPE-DIET / 2018/01183
- Conditions
- Muscle Weakness, Bone Health, Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Health Promotion Board (HPB), Saw Swee Hock Shool of Public Health, National University of Singapore
- Study start
- Jan 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control (No intervention) | No intervention | –Participants will not undergo any treatment. Continue with usual daily activities and diet for 6 months. |
| Nutrition group | Experimental | Other: Protein supplementation and regular physical activityParticipants will receive protein enriched food to supplement the diet for 6 months. |
| Exercise group | Experimental | Other: Protein supplementation and regular physical activityParticipants will exercise 3 times a week for 60 minutes each time over 6 months. |
| Nutrition + Exercise group | Experimental | Other: Protein supplementation and regular physical activityParticipants will receive protein enriched food to supplement the diet and exercise 3 times a week for 60 minutes each time over 6 months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- With kidney conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein supplementation and regular physical activityTo determine if high protein diet and/or regular physical activity improves muscle and bone health | Other | Exercise group, Nutrition + Exercise group, Nutrition group |
Primary outcome
Changes in frailty status
Time frame: 2 years
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
Time frame: 2 years
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.
24 secondary outcomes
Changes in upper extremity muscle strength
Time frame: 2 years
Changes in skeletal muscle mass
Time frame: 2 years
Changes in sarcopenic status
Time frame: 2 years
Changes in mood
Time frame: 2 years
Changes in mood
Time frame: 2 years
Changes in cognitive function
Time frame: 2 years
Changes in cognitive function
Time frame: 2 years
Changes in nutritional status
Time frame: 2 years
Changes in functional status (instrumental activities of daily living)
Time frame: 2 years
Changes in functional status (activities of daily living)
Time frame: 2 years
Changes in fall risk
Time frame: 2 years
Incidence of self-reported falls
Time frame: 2 years
Changes in quality of life
Time frame: 2 years
Changes in social engagement
Time frame: 2 years
Changes in systemic inflammation
Time frame: 2 years
Changes in systemic inflammation
Time frame: 2 years
Changes in systemic inflammation
Time frame: 2 years
Changes in phase angle by bioelectrical impedance analysis
Time frame: 2 years
Changes in protein mass
Time frame: 2 years
Changes in level of bone biomarkers
Time frame: 2 years
Changes in level of bone biomarkers
Time frame: 2 years
Changes in level of bone biomarkers
Time frame: 2 years
Acceptance of protein enriched food by local seniors
Time frame: 2 years
Cost-effectiveness analysis
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Protein supplementation and regular physical activity in people with Muscle Weakness and Bone Health, run by National University Hospital, Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in frailty status (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.