Fernández Jiménez R, García-Rey S, Vegas Aguilar I M, Jiménez-Sánchez A, Montero Madrid N, Roque Cuellar M C, Galán A, Garrancho Domínguez P, González León R, Zamora P, Moreno-Domínguez R, de Castellar Sansó R, García-Luna P P, García Almeida J M
Department of Endocrinology and Nutrition, Virgen de la Victoria University Hospital, 29010 Malaga, Spain; Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, 29010 Malaga, Spain.
Clinical Nutrition and Dietetics Unit, Department of Endocrinology and Nutrition. Hospital Universitario Virgen del Rocio, 41013 Sevilla, Spain.
Clin Nutr ESPEN. 2025 Aug;68:348-358. doi: 10.1016/j.clnesp.2025.05.025. Epub 2025 May 19.
BACKGROUND & AIMS: Hip fracture due to fragility (HFF) has a high mortality rate and leads to a decline in quality of life due to advanced age and compromised nutritional status, among others. The aim of this study was to evaluate the impact of early nutritional intervention (hyperproteic and hypercaloric oral nutritional supplement; HP/HC-ONS) on the nutritional and functional recovery of older patients with HFF.
Double-blind, placebo-controlled clinical trial in patients >65 years old with scheduled HFF surgery (≤72 h). Patients were randomly assigned to HP/HC-ONS or placebo group (two doses/day) for 4 months. Nutritional diagnosis was based on Mini Nutritional Assessment (MNA), and "morphofunctional assessment": a combination of body composition techniques, such as bioelectrical impedance analysis (BIA) with phase angle (PhA), and nutritional ultrasound (US) with rectus femoris cross-sectional area (RF-CSA) and circumference; and muscle function measured using handgrip strength (HGS). Primary statistical analysis endpoints were changes between baseline and 4-month PhA and HGS. Laboratory parameters (C reactive protein and prealbumin, amongst others), dependency (Barthel index), and disease burden (Charlson Comorbidity Index, CCI) were registered. All measurements took place at baseline, 2-month (except for BIA), and 4-month on-site visits. Hospital length of stay (LoS) was extracted from health records. Adverse events (AEs) were reported, and product tolerability was assessed by stool frequency and the Bristol Stool Form Scale (BSFS).
85 patients were included (HP/HC-ONS, n = 45; placebo, n = 40); 75.9% women. Final PhA displayed a significant interaction between treatment group and baseline PhA (ANCOVA, p = 0.002): the HP/HC-ONS group developed a significantly higher 4-month PhA if basal PhA was >4°. Significantly higher increases of RF-CSA and circumference were observed in the HP/HC-ONS group. HGS and MNA improved, yet without significant differences between groups. No statistically significant differences between groups were noted in LoS, BSFS, Barthel Index, CCI, and laboratory parameters at 4-month. AEs reported at 4-month: placebo, 14 (70%) and HP/HC-ONS, 6 (30%); with 3 serious AEs related with the product (HP/HC ONS, 2 [diarrhea], and placebo, 1 [vomits]).
In older adults recovering from HFF, an early 4-month HP/HC-ONS intervention was well tolerated, safe, and demonstrated a beneficial impact on body composition outcomes.
脆性髋部骨折（HFF）死亡率高，且因高龄和营养状况不佳等因素导致生活质量下降。本研究旨在评估早期营养干预（高蛋白高热量口服营养补充剂；HP/HC-ONS）对老年HFF患者营养和功能恢复的影响。
对计划进行HFF手术（≤72小时）的65岁以上患者进行双盲、安慰剂对照临床试验。患者被随机分为HP/HC-ONS组或安慰剂组（每日两剂），为期4个月。营养诊断基于微型营养评定法（MNA）以及“形态功能评估”：综合运用多种身体成分分析技术，如带相位角（PhA）的生物电阻抗分析（BIA）和带股直肌横截面积（RF-CSA）及周长的营养超声（US）；并使用握力（HGS）测量肌肉功能。主要统计分析终点为基线与4个月时PhA和HGS的变化。记录实验室参数（如C反应蛋白和前白蛋白等）、自理能力（Barthel指数）及疾病负担（Charlson合并症指数，CCI）。所有测量均在基线、2个月（BIA除外）和4个月的现场访视时进行。住院时长（LoS）从健康记录中提取。报告不良事件（AE），并通过排便频率和布里斯托大便分类法（BSFS）评估产品耐受性。
纳入85例患者（HP/HC-ONS组，n = 45；安慰剂组，n = 40）；女性占75.9%。最终PhA显示治疗组与基线PhA之间存在显著交互作用（协方差分析，p = 0.002）：如果基础PhA>4°，HP/HC-ONS组4个月时的PhA显著更高。HP/HC-ONS组的RF-CSA和周长增加显著更高。HGS和MNA有所改善，但两组间无显著差异。在住院时长、BSFS、Barthel指数、CCI及4个月时的实验室参数方面，两组间未观察到统计学显著差异。4个月时报告的AE：安慰剂组14例（70%），HP/HC-ONS组6例（30%）；有3例严重AE与产品相关（HP/HC ONS组2例[腹泻]，安慰剂组1例[呕吐]）。
在从HFF恢复的老年人中，早期4个月的HP/HC-ONS干预耐受性良好、安全，并对身体成分指标产生有益影响。
