Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-03 @ 8:46 AM
Study NCT ID:
NCT03786835
Status:
UNKNOWN
Last Update Posted:
2018-12-26
First Post:
2018-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Older People Everyday (HOPE) - Role of Healthy Diet on Muscle and Bone Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2018-12-11', 'studyFirstSubmitQcDate': '2018-12-20', 'lastUpdatePostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in frailty status', 'timeFrame': '2 years', 'description': 'Changes in frailty status by 5-item FRAIL scale Scale range from 0 to 5, the higher the value, the more frail.'}, {'measure': 'Changes in lower extremity physical performance', 'timeFrame': '2 years', '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.\n\nThe higher the value, the better the performance of lower extremity.'}], 'secondaryOutcomes': [{'measure': 'Changes in upper extremity muscle strength', 'timeFrame': '2 years', 'description': 'Changes in handgrip strength test performance (kg)'}, {'measure': 'Changes in skeletal muscle mass', 'timeFrame': '2 years', 'description': 'Changes in skeletal muscle mass by bioelectrical impedance analysis'}, {'measure': 'Changes in sarcopenic status', 'timeFrame': '2 years', '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'}, {'measure': 'Changes in mood', 'timeFrame': '2 years', 'description': 'Changes in Geriatric Depression Scale (GDS) Scale range from 0 to 15, the higher the score, the greater the likelihood of depression.'}, {'measure': 'Changes in mood', 'timeFrame': '2 years', 'description': 'Changes in UCLA Loneliness Scale Scale range from 0 to 9, the higher the value, the greater the loneliness Scale from 0 to'}, {'measure': 'Changes in cognitive function', 'timeFrame': '2 years', '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.'}, {'measure': 'Changes in cognitive function', 'timeFrame': '2 years', 'description': 'Changes in Montreal Cognitive Assessment (MoCA)'}, {'measure': 'Changes in nutritional status', 'timeFrame': '2 years', '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.'}, {'measure': 'Changes in functional status (instrumental activities of daily living)', 'timeFrame': '2 years', 'description': 'Changes in Instrumental Activities of Daily Living (IADL) score Scale range from 0 to 8, the higher the value, the greater the ability.'}, {'measure': 'Changes in functional status (activities of daily living)', 'timeFrame': '2 years', 'description': 'Changes in Activities of Daily Living (ADL) score Scale range from 0 to 6, the higher the value, the greater the ability.'}, {'measure': 'Changes in fall risk', 'timeFrame': '2 years', 'description': 'Changes in fall efficacy questionnaire'}, {'measure': 'Incidence of self-reported falls', 'timeFrame': '2 years', 'description': 'Number of falls assessed by questionnaires'}, {'measure': 'Changes in quality of life', 'timeFrame': '2 years', '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.'}, {'measure': 'Changes in social engagement', 'timeFrame': '2 years', 'description': 'Changes in Lubben Social Network Scale. Scale range from 0 to 30, the higher the value, the greater the social engagement'}, {'measure': 'Changes in systemic inflammation', 'timeFrame': '2 years', 'description': 'Changes in Tumour necrosis factor alpha (TNF-a)'}, {'measure': 'Changes in systemic inflammation', 'timeFrame': '2 years', 'description': 'Changes in Interleukin-10'}, {'measure': 'Changes in systemic inflammation', 'timeFrame': '2 years', 'description': 'Changes in Interleukin-6'}, {'measure': 'Changes in phase angle by bioelectrical impedance analysis', 'timeFrame': '2 years', 'description': 'Changes in phase angle by bioelectrical impedance analysis'}, {'measure': 'Changes in protein mass', 'timeFrame': '2 years', 'description': 'Changes in protein mass by bioelectrical impedance analysis'}, {'measure': 'Changes in level of bone biomarkers', 'timeFrame': '2 years', 'description': 'Changes in level of serum sclerotin'}, {'measure': 'Changes in level of bone biomarkers', 'timeFrame': '2 years', 'description': 'Changes in level of serum osteocalcin'}, {'measure': 'Changes in level of bone biomarkers', 'timeFrame': '2 years', 'description': 'Changes in level of free Vitamin D'}, {'measure': 'Acceptance of protein enriched food by local seniors', 'timeFrame': '2 years', 'description': 'Assessed by taste test questionnaire'}, {'measure': 'Cost-effectiveness analysis', 'timeFrame': '2 years', '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscle Weakness', 'Bone Health', 'Cognitive Decline']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.", 'detailedDescription': '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.\n\nEvidence 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.\n\nLocally, 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.\n\nIn 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least pre-frail (Frail scale score of at least 1) but ambulant\n* Grip strength not more than 25kg for males and 18kg for females\n\nExclusion Criteria:\n\n* With kidney conditions'}, 'identificationModule': {'nctId': 'NCT03786835', 'acronym': 'HOPE-DIET', 'briefTitle': 'Healthy Older People Everyday (HOPE) - Role of Healthy Diet on Muscle and Bone Health', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'Healthy Older People Everyday (HOPE) - Role of Healthy Diet on Muscle and Bone Health', 'orgStudyIdInfo': {'id': '2018/01183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control (No intervention)', 'description': 'Participants will not undergo any treatment. Continue with usual daily activities and diet for 6 months.'}, {'type': 'EXPERIMENTAL', 'label': 'Nutrition group', 'description': 'Participants will receive protein enriched food to supplement the diet for 6 months.', 'interventionNames': ['Other: Protein supplementation and regular physical activity']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': 'Participants will exercise 3 times a week for 60 minutes each time over 6 months.', 'interventionNames': ['Other: Protein supplementation and regular physical activity']}, {'type': 'EXPERIMENTAL', 'label': 'Nutrition + Exercise group', '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.', 'interventionNames': ['Other: Protein supplementation and regular physical activity']}], 'interventions': [{'name': 'Protein supplementation and regular physical activity', 'type': 'OTHER', 'description': 'To determine if high protein diet and/or regular physical activity improves muscle and bone health', 'armGroupLabels': ['Exercise group', 'Nutrition + Exercise group', 'Nutrition group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Promotion Board (HPB)', 'class': 'UNKNOWN'}, {'name': 'Saw Swee Hock Shool of Public Health, National University of Singapore', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head & Senior Consultant, Division of Geriatric Medicine', 'investigatorFullName': 'Medicine', 'investigatorAffiliation': 'National University Hospital, Singapore'}}}}