Impact of an oral nutritional supplement on the recovery of the nutritional status of older patients with fragility hip fracture: Controlled and randomized clinical trial

Abstract

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.

Methods

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).

Results

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]).

Conclusions

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.