Clinical trial NCT06547593: A Multifaceted Nutrition Intervention for Frailty in the Community Elderly
Official title: A Multifaceted Nutrition Intervention for Frailty in the Community Elderly: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frail
Elderly
Nutrition Disorders in Old Age
Keywords: multifaceted nutrition
frail
elderly
community
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 315
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: With world's older population is rapidly increasing. China's population aging process is also accelerating. Studies have shown that persistent frailty can increase the incidence of negative events in the elderly. However, research on elderly frailty in China is still in its early stages, and existing research in China mainly focuses on the definition of frailty, evaluation tools for frailty, and cross-sectional surveys of small populations. There is currently limited research on interventions.

The MultIfaceted NUtrition inTErvention for Frailty (minute) trial is a randomized, controlled trial to explore the trajectory characteristics and influencing factors of frailty in the community, the impact of nutritional interventions on the developmental trajectory of frailty in the elderly in the community and the management model and appropriate technology for the sustainable intervention of frailty in the elderly based on the community.

A total of 315 frail older adults will be recruited from Beijing. After the screening period, the compliant participants will be randomized to the control group, the nutrition intervention group with the nutrition intervention alone, or the combined nutrition intervention group with combining exercise and nutrition, on a 1:1:1 ratio, for 3 months. The primary outcome is the change in SPPB from the baseline to the end of the study. The change in SPPB as a primary outcome, and frailty status, demographic information, health status, nutrition assessment, comprehensive geriatric assessment status, quality of life, intrinsic capacity, and mental elasticity as secondary outcomes will be measured using validated questionnaires and clinical examinations.

This trial adheres to the Declaration of Helsinki and guidelines of Good Clinical Practice. Signed informed consent will be obtained from all participants. The trial has been approved by the Peking University Institutional Review Board (approval number: IRB00001052-23178). The results will be disseminated through academic conferences and publications in international peer-reviewed journals.

Detailed description: The global elderly population is rapidly increasing, with the 65-and-over age group being the fastest growing. Currently, about 9% of the world's population is over 65, and this proportion is projected to reach 16% by 2050. The silvering of China's population continues its steady march. By the end of 2023, the population aged 60 and above is 296.97 million, accounting for 21.1% of the national population, of which 216.76 million are aged 65 and above, accounting for 15.4% of the national population. As China's population continues to age, the silver tsunami shows no signs of abating. By 2030, it is estimated that the number of elderly individuals aged 65 and above will have surged to approximately 240 million. And by 2050, the ranks of octogenarians and above are projected to reach a staggering 100 million. The overall health status of China's elderly population is a cause for concern. More than 80% of individuals aged 65 and above suffer from at least one chronic disease, and by the age of 75, this number increases to at least three. Approximately 44 million elderly citizens are either partially or fully disabled, casting a long shadow over their own lives, placing a significant burden on their families, and society. The health of China's elderly has become a pressing public health issue that demands the attention of the entire nation. Frailty is a geriatric syndrome characterized by an increased vulnerability to stressors. It is a state of diminished physiological reserve and impaired function across multiple organ systems, leading to increased dependency and mortality. Epidemiological data suggest that the prevalence of frailty in the elderly population ranges from approximately 4.9% to 27.3%. Among community-dwelling elderly individuals, the prevalence is estimated to be between 6.9% and 14.9%. The incidence of frailty increases with advancing age, with over 25% of individuals aged 85 and older experiencing this debilitating condition. Research has painted a sobering picture of the consequences of persistent frailty in the elderly population. It has been shown to increase the risk of a cascade of negative events, including falls, disability, delirium, hospitalization, and even premature mortality. The risk of morbidity and mortality escalates significantly, with a 68% increase in all-cause mortality for every 0.1-unit increase in the frailty index (HR=1.68, 95% CI: 1.66-1.71). Frailty also places a heavy burden on caregivers and healthcare systems, straining resources and exacerbating the challenges of caring for an aging population. Furthermore, frail elderly individuals are particularly vulnerable to precipitous declines in health, even from minor stressors such as infections, new medications, falls, constipation, or urinary retention. These events can trigger a downward spiral, leading to hospitalization, disability, and even death, severely compromising the quality of life for elderly individuals and placing a greater demand on healthcare services. In the global tapestry of frailty research, interventions have largely focused on isolated threads, such as exercise regimens, nutritional counseling, risk factor modification, and comprehensive care. However, the intricate web of frailty demands a more holistic approach, one that weaves together these diverse strands. There is a notable lack of research investigating comprehensive intervention measures. It is of utmost importance to conduct community-based research to explore a comprehensive nutritional intervention model for frailty that is tailored to the unique characteristics of the Chinese population, scientifically sound, and sustainable.

Eligibility criteria: Inclusion Criteria:

1. Frailty assessed by the frail phenotype
2. Aged between 65 and 85 years old

Exclusion Criteria:

1. Multiple serious diseases such as stroke, cerebral infarction, tumors, and severe cardiovascular and cerebrovascular diseases
2. Disability, dementia; severe visual and hearing impairments, and physical activity impairment
3. Moderate to severe anxiety and depression
4. Unable to complete this study as requested

Primary outcomes:
measure: Short Physical Performance Battery (SPPB) score
timeFrame: at the 3-month intervention and at the 3-month, 6-monthand 12-month follow-up investigations
measure: frailty scores
timeFrame: at the 3-month intervention and at the 3-month, 6-month and 12-month follow-up investigations
Secondary outcomes:
measure: frailty trajectories
timeFrame: at the 3-month intervention and at the 3-month, 6-month and 12-month follow-up investigations
measure: intrinsic capacity
timeFrame: at the 3-month intervention and at the 3-month, 6-month and 12-month follow-up investigations
measure: Malnutrition risk assessment
timeFrame: at the 3-month intervention and at the 3-month, 6-month and 12-month follow-up investigations
measure: frailty recovery rates
timeFrame: at the 3-month intervention and at the 3-month, 6-month and 12-month follow-up investigations
measure: Serum protein
timeFrame: at the 3-month intervention and at the 3-month and 12-month follow-up investigations
measure: Urine 8-hydroxyguanosine (8-oxo-Gsn)
timeFrame: at the 3-month intervention and at the 3-month and 12-month follow-up investigations
measure: Serum inflammatory factors
timeFrame: at the 3-month intervention and at the 3-month and 12-month follow-up investigations
measure: changes in serum differential metabolites
timeFrame: At the beginning of the intervention and in the third month of the intervention
measure: changes in gut microbiota
timeFrame: At the beginning of the intervention and in the third month of the intervention
measure: participants' satisfaction
timeFrame: At the beginning of the intervention and in the third month of the intervention
measure: cognition function
timeFrame: at the 3-month intervention and at the 6-month and 12-month follow-up investigations
measure: Sleep conditions
timeFrame: at the 3-month intervention and at the 6-month and 12-month follow-up investigations
measure: adverse event
timeFrame: at the 3-month intervention and at the 6-month and 12-month follow-up investigations
Other outcomes:
Locations:
city: Beijing
country: China
facility: Qingta Community Health Service Center
state: Beijing
Study officials:
affiliation: Peking University
name: Zhaofeng Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: