Clinical trial NCT03786835: Healthy Older People Everyday (HOPE) - Role of Healthy Diet on Muscle and Bone Health
Official title: Healthy Older People Everyday (HOPE) - Role of Healthy Diet on Muscle and Bone Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Weakness
Bone Health
Cognitive Decline
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Health Promotion Board (HPB)
name: Saw Swee Hock Shool of Public Health, National University of Singapore
First posted: 2018-12-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in frailty status
timeFrame: 2 years
measure: Changes in lower extremity physical performance
timeFrame: 2 years
Secondary outcomes:
measure: Changes in upper extremity muscle strength
timeFrame: 2 years
measure: Changes in skeletal muscle mass
timeFrame: 2 years
measure: Changes in sarcopenic status
timeFrame: 2 years
measure: Changes in mood
timeFrame: 2 years
measure: Changes in mood
timeFrame: 2 years
measure: Changes in cognitive function
timeFrame: 2 years
measure: Changes in cognitive function
timeFrame: 2 years
measure: Changes in nutritional status
timeFrame: 2 years
measure: Changes in functional status (instrumental activities of daily living)
timeFrame: 2 years
measure: Changes in functional status (activities of daily living)
timeFrame: 2 years
measure: Changes in fall risk
timeFrame: 2 years
measure: Incidence of self-reported falls
timeFrame: 2 years
measure: Changes in quality of life
timeFrame: 2 years
measure: Changes in social engagement
timeFrame: 2 years
measure: Changes in systemic inflammation
timeFrame: 2 years
measure: Changes in systemic inflammation
timeFrame: 2 years
measure: Changes in systemic inflammation
timeFrame: 2 years
measure: Changes in phase angle by bioelectrical impedance analysis
timeFrame: 2 years
measure: Changes in protein mass
timeFrame: 2 years
measure: Changes in level of bone biomarkers
timeFrame: 2 years
measure: Changes in level of bone biomarkers
timeFrame: 2 years
measure: Changes in level of bone biomarkers
timeFrame: 2 years
measure: Acceptance of protein enriched food by local seniors
timeFrame: 2 years
measure: Cost-effectiveness analysis
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References: