Multifaceted Nutrition Intervention for Frail Elderly in the Community: Protocol of a Randomized Controlled Trial...

The rapid aging of China's population poses significant challenges, particularly in public health and medical services. Frailty, a reversible geriatric syndrome, is a critical intervention target for disability prevention among older adults.

We hypothesize that both intervention groups will demonstrate significant improvements in Short Physical Performance Battery (SPPB) scores compared to the control group, and that these improvements will be accompanied by parallel reductions in inflammatory markers and beneficial alterations in the gut microbiota.

The MultIfaceted NUtrition inTervention for frail Elderly (MINUTE) trial is a randomized, parallel-group controlled trial. In Beijing, China, 315 frail older adults were recruited and randomly assigned to 3 groups: a control group receiving routine community health management only, multifaceted nutrition intervention group, and a multifaceted nutrition and exercise combined intervention group, each comprising 105 participants. The study consists of a three-month intervention period followed by a nine-month follow-up. During the three-month intervention period, the control group receives routine community health management, while the multifaceted nutrition intervention group receives daily dietary guidance, personalized nutrition consultations, and health education. Additionally, the combined intervention group receives exercise interventions in addition to the nutritional components. After the three-month intervention, all three groups will be followed up for nine months to assess the sustainability of the study.

The primary outcomes are the changes in the SPPB scores. The secondary outcomes include frailty scores, intrinsic capacity, malnutrition risk, frailty recovery rates, serum differential metabolites, inflammatory factors, and gut microbiota changes. This study aims to establish a scalable and sustainable pathway for frailty prevention among community-dwelling older adults in China and provide valuable insights to inform strategies for healthy aging.

This study is conducted in accordance with the Declaration of Helsinki and approved by the Peking University Institutional Review Board (IRB00001052-23178) on February 3, 2024, with all amendments subject to prior review and approval. Informed consent is obtained from participants, and findings will be disseminated through peer-reviewed publications, conference presentations, and summaries for school staff and participants.

gov (NCT06547593) registered 30 July 2024.