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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

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 groups in NCT03786835
Study groupRoleWhat they receive
Control (No intervention)No interventionParticipants will not undergo any treatment. Continue with usual daily activities and diet for 6 months.
Nutrition groupExperimentalParticipants will receive protein enriched food to supplement the diet for 6 months.
Receives: Other: Protein supplementation and regular physical activity
Exercise groupExperimentalParticipants will exercise 3 times a week for 60 minutes each time over 6 months.
Receives: Other: Protein supplementation and regular physical activity
Nutrition + Exercise groupExperimentalParticipants 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.

  1. 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

  2. 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)
  1. Changes in upper extremity muscle strength

    Changes in handgrip strength test performance (kg)

    Measured: 2 years

  2. Changes in skeletal muscle mass

    Changes in skeletal muscle mass by bioelectrical impedance analysis

    Measured: 2 years

  3. 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

  4. 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

  5. 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

  6. 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

  7. Changes in cognitive function

    Changes in Montreal Cognitive Assessment (MoCA)

    Measured: 2 years

  8. 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

  9. 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

  10. 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

  11. Changes in fall risk

    Changes in fall efficacy questionnaire

    Measured: 2 years

  12. Incidence of self-reported falls

    Number of falls assessed by questionnaires

    Measured: 2 years

  13. 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

  14. 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

  15. Changes in systemic inflammation

    Changes in Tumour necrosis factor alpha (TNF-a)

    Measured: 2 years

  16. Changes in systemic inflammation

    Changes in Interleukin-10

    Measured: 2 years

  17. Changes in systemic inflammation

    Changes in Interleukin-6

    Measured: 2 years

  18. Changes in phase angle by bioelectrical impedance analysis

    Changes in phase angle by bioelectrical impedance analysis

    Measured: 2 years

  19. Changes in protein mass

    Changes in protein mass by bioelectrical impedance analysis

    Measured: 2 years

  20. Changes in level of bone biomarkers

    Changes in level of serum sclerotin

    Measured: 2 years

  21. Changes in level of bone biomarkers

    Changes in level of serum osteocalcin

    Measured: 2 years

  22. Changes in level of bone biomarkers

    Changes in level of free Vitamin D

    Measured: 2 years

  23. Acceptance of protein enriched food by local seniors

    Assessed by taste test questionnaire

    Measured: 2 years

  24. 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.

  1. First posted26 Dec 2018
  2. Study startJan 2019 (estimated)
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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)
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

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.

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