数据日期 2026-10-29 · 生成时间 2026-10-29 06:03
研究问题
In Western countries, life spans are high; most older people develop a low-grade pro-inflammatory status termed “inflammaging”, characterized by elevated circulating levels of pro-inflammatory markers [1].
方法
An open-label, non-blinded, non-commercial, multi-center, randomized, controlled trial was conducted.；Patients were recruited at the Cardiac Rehabilitation Unit of the IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico–Scientific Institute for Research, Hospitalization and Care) Fondazione Don Carlo Gnocchi (FDG) ETS (Ente del Terzo Settore–Third Sector Entity) of Florence from May 2018 to December 2019.；The Dietetic and Clinical Nutrition Service (DCNS), composed of physicians and dietitians, operates within the IRCCS Fondazione Don Carlo Gnocchi of Florence, a general rehabilitation and research hospital that admits patients primarily referred by acute care hospitals.；Each patient was informed of the purpose of the study and provided written informed consent.
核心结论
Gut Microbiome Analysis] After a rigorous quality check and preprocessing, which removed about 20% of the sequences, all sequences were normalized to 7000 sequences per sample, resulting in a total of 187,807 OTUs, with a median of 1970 OTUs per sample.；They evidenced a similar richness of OTUs, that is, a similar bacterial composition; COT0–COT1: there was an increase in alpha diversity in COT1, and composition was significantly different (p < 0.01); CAT0–COT0: increase in alpha diversity in COT0 and significantly different (p < 0.01); CAT0–COT1: increase in diversity in COT1 and significantly different (p < 0.001); CAT1–COT1: increase in diversity in COT1 and significantly different (p < 0.001). ‖ 结论：In polymorbid patients receiving polypharmacy during rehabilitation, non-pharmacological dietary interventions devoid of side effects may represent a crucial strategy to reduce risk factors, shorten lengths of hospital stay, alleviate comorbidity burden, and reduce healthcare costs for national health systems.
局限
It should be noted that this study has some limitations, largely related to the sample size (N = 27), which characterizes this study as a preliminary/exploratory pilot trial; caution must be exercised to avoid over-extrapolating these findings to broader populations.；Additionally, the discrepancy between the distribution of men and women between the two groups—with the control group having more female patients (54%) compared to the case group (21%)—is another limitation.；It could be interesting to strengthen our preliminary results in a future, larger, randomized sex-stratified clinical trial.
对本项目的价值
★★★★★ 干预证据决定参照标准效应量——任何抗衰干预的收益至少应对标该基线。随机对照；命中核心 微生物组。
全文来源
PMC JATS 全文（正文 42,572 字符，已过标题/DOI 逐字归属校验）
原文题录
- 英文标题：An Exploratory Randomized Clinical Trial to Assess the Effects of Vitamin D and Leucine-Enriched Whey Protein Supplementation on Inflammaging and Gut Eubacterial Biomass in Cardiac Rehabilitation Patients.
- 期刊与标识：Biomolecules · PMID 42939738 · DOI 10.3390/biom16101484**
A 级证据分级：A 级（同行评议人体研究）
本文属人体研究证据，但需注意：观察性或小样本干预的结论不等于已证实临床获益；效应量与长期安全性仍需更大规模、更长随访的试验验证。
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