A Multifaceted Nutrition Intervention for Frailty in the Community Elderly
NCT Number: NCT06547593
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Frail|Elderly|Nutrition Disorders in Old Age
Interventions: BEHAVIORAL: multifaceted nutrition intervention|BEHAVIORAL: Nutritional and Exercise Combined Intervention|BEHAVIORAL: Control Group
Sponsor: Zhaofeng Zhang
Sex: ALL
Age: OLDER_ADULT
Enrollment: 315
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-30
Completion Date: 2025-12-31
Locations: Qingta Community Health Service Center, Beijing, Beijing, China

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.

Primary Outcome Measures: Short Physical Performance Battery (SPPB) score, The primary outcome was the change in the Short Physical Performance Battery (SPPB) score between groups, and the change from baseline to the end of the study., at the 3-month intervention and at the 3-month, 6-monthand 12-month follow-up investigations|frailty scores, The frailty scores were evaluated using Fried Frailty Phenotype and Tilburg Frailty Indicator, at the 3-month intervention and at the 3-month, 6-month and 12-month follow-up investigations
Secondary Outcome Measures: frailty trajectories, Changes in frailty trajectories before and after the intervention, as measured by the Frailty Index., at the 3-month intervention and at the 3-month, 6-month and 12-month follow-up investigations|intrinsic capacity, Changes in intrinsic capacity before and after the intervention, and between groups; The intrinsic capacity is measured using the World Health Organization's (WHO) Integrated Care for Older People (ICOPE) approach., at the 3-month intervention and at the 3-month, 6-month and 12-month follow-up investigations|Malnutrition risk assessment, Measured by 《Malnutrition Risk Assessment Form for the Elderly》, at the 3-month intervention and at the 3-month, 6-month and 12-month follow-up investigations|frailty recovery rates, Difference in frailty scores before and after intervention, at the 3-month intervention and at the 3-month, 6-month and 12-month follow-up investigations|Serum protein, serum total protein, albumin and transferrin, at the 3-month intervention and at the 3-month and 12-month follow-up investigations|Urine 8-hydroxyguanosine (8-oxo-Gsn), Urine oxidation marker 8-hydroxyguanosine (8-oxo-Gsn) level, at the 3-month intervention and at the 3-month and 12-month follow-up investigations|Serum inflammatory factors, C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor - α (TNF - α), insulin-like growth factor-1 (IGF-1), C-X-C-motif chemokine 10 (CXCL10), chemokine C-X3-C-based ligand 1 (CX3CL1) in serum using ELISA, at the 3-month intervention and at the 3-month and 12-month follow-up investigations|changes in serum differential metabolites, Using non targeted metabolomics methods to examine the changes in serum differential metabolites in each group before and after intervention, and elucidate the mechanism of intervention, At the beginning of the intervention and in the third month of the intervention|changes in gut microbiota, Using 16S sequencing method to detect changes in gut microbiota and differential bacterial genera among groups, At the beginning of the intervention and in the third month of the intervention|participants' satisfaction, participants satisfaction and acceptability is evaluated using a self-made scale, At the beginning of the intervention and in the third month of the intervention|cognition function, cognition function is evaluated using Mini-Mental State Examination, MMSE, at the 3-month intervention and at the 6-month and 12-month follow-up investigations|Sleep conditions, Sleep conditions is evaluated using Pittsburgh sleep quality index, at the 3-month intervention and at the 6-month and 12-month follow-up investigations|adverse event, serious adverse events, unexpected adverse events, and adverse events that occurred while the participant was under the supervision or guidance of study staff either onsite or offsite., at the 3-month intervention and at the 6-month and 12-month follow-up investigations