Dietary Supplements

Systematic high-calorie, high-protein oral nutritional support in hospitalized, moderately hypophagic patients at nutritional risk: A randomized-controlled trial.

TL;DR

In acutely hospitalized adult patients at nutritional risk and without severe hypophagia, the systematic use of ONSs since admission improved body composition, muscle function, and protein-calorie intake, and reduced LOS.

Key Findings

Systematic oral nutritional supplementation since hospital admission significantly improved phase angle at day 8 compared to on-demand supplementation.

  • Mean difference in phase angle (PhA) at day 8: 0.47 (95% CI, 0.31–0.62); P < 0.001
  • 201 patients were re-assessed at day 8 and at discharge out of 220 randomized
  • Systematic ONS group: n = 100
  • Phase angle measured by bioelectrical impedance analysis was the primary endpoint

The improvement in phase angle with systematic ONS was sustained through hospital discharge.

  • Mean difference in PhA at discharge: 0.49 (95% CI, 0.33–0.64); P < 0.001
  • Effect size at discharge was similar to that observed at day 8 (0.49 vs. 0.47)
  • Discharge assessment was a secondary endpoint

Systematic ONS resulted in significantly greater body weight and protein-calorie intake at all time points during hospitalization.

  • Significant effect found for body weight at all time points (P < 0.001)
  • Significant effect found for protein-calorie intake at all time points (P < 0.001)
  • High-protein ONSs were used in the intervention arm
  • Nutritional counseling was provided to both groups

Systematic ONS improved muscle strength at discharge.

  • Significant effect for muscle strength at discharge (P = 0.042)
  • Muscle strength was assessed as a secondary outcome
  • No statistically significant effect on muscle strength was reported at day 8 specifically

Systematic ONS since admission reduced length of hospital stay by 2 days compared to on-demand supplementation.

  • Length of stay reduction: -2 days; P = 0.044
  • LOS was a secondary outcome measure
  • Patients enrolled had an expected length of stay ≥7 days at enrollment
  • The trial was conducted at a single site from July 2016 to July 2024

The trial enrolled acutely hospitalized adults at nutritional risk without severe hypophagia, using NRS-2002 as the screening tool.

  • Inclusion criteria: NRS-2002 score ≥ 3, expected LOS ≥ 7 days, food intake ≥ 50% of estimated calorie requirements
  • Severe hypophagia was defined as food intake < 50% of estimated calorie requirements and was an exclusion criterion
  • N = 220 randomized; N = 201 completed assessments at day 8 and discharge
  • Design: single-site, open-label, randomized, controlled trial (NCT02763904)
  • Control group received on-demand ONS starting on day 8 along with nutritional counseling

The rate of acquired infections was also evaluated as a secondary outcome in the trial.

  • Rate of acquired infections was listed as a secondary outcome alongside LOS
  • Specific infection rate results were not reported in the abstract
  • The study was designed to assess multiple clinical outcomes beyond body composition

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Citation

Cereda E, Borioli V, Caraccia M, Ugg&#xe8; A, De Simeis F, Bruno R, et al.. (2026). Systematic high-calorie, high-protein oral nutritional support in hospitalized, moderately hypophagic patients at nutritional risk: A randomized-controlled trial.. Clinical nutrition (Edinburgh, Scotland). https://doi.org/10.1016/j.clnu.2025.11.017