High Protein Oral Nutritional Supplements Enable the Majority of Cancer Patients to Meet Protein Intake Recommendations during Systemic Anti-Cancer Treatment: A Randomised Controlled Parallel-Group Study.

ESPEN guidelines recommend a minimum protein intake of 1.0 g/kg body weight (BW) per day to maintain or restore lean body mass in patients with cancer. During anti-cancer treatment, optimal protein intake is difficult to achieve. We investigated whether a high-protein, low-volume oral nutritional supplement (ONS) supports patients in meeting recommendations. A multi-centre, randomised, controlled, open-label, parallel-group study was carried out in nine hospitals (five countries) between January 2019 and July 2021 in colorectal and lung cancer patients undergoing first-line systemic treatment with chemo(radio-) or immunotherapy. Subjects were randomised (2:1) to receive Fortimel Compact Protein® or standard care. Protein intake was assessed with a 3-day food diary (primary outcome). BW was a secondary outcome. Due to challenges in recruitment, the study was terminated prematurely with 42 patients randomised (intervention group (IG) 28; control group (CG) 14). At T1 and T2, protein intake was statistically significantly higher in the IG compared to the CG (1.40 vs. 1.07 g/kg/day at T1, p = 0.008; 1.32 vs. 0.94 g/kg/day at T2, p = 0.002). At baseline, only 65% (IG) and 45% (CG) of patients met ESPEN minimum protein intake recommendations. However, at T1 and T2 in the IG, a higher proportion of patients met recommendations than in the CG (88% vs. 55% and 40%). No statistically significant difference between study groups was observed for BW. Mean compliance to the ONS was 73.4%. A high-protein, low-volume ONS consumed twice daily enables the majority of patients to reach minimal ESPEN protein recommendations.

Evident lower blood levels of multiple nutritional compounds and highly prevalent malnutrition in sub-acute stroke patients with or without dysphagia.

Introduction: Malnutrition is prevalent after stroke, particularly if post-stroke oropharyngeal dysphagia (OD) reduces nutritional intake. To further understand stroke-related malnutrition, a thorough nutritional assessment was performed in ischemic stroke patients with or without OD during sub-acute inpatient rehabilitation. Methods: In this exploratory, observational, cross-sectional, multi-center study in Germany (NTR6802), ischemic stroke patients with (N = 36) or without (N = 49) OD were age- and sex-matched to healthy reference subjects. Presence of (risk of) malnutrition (MNA-SF), blood concentration of stroke-relevant nutritional compounds and metabolites, nutritional intake, quality of life (EQ-5D-5L), and activities of daily living (Barthel index) were assessed. Results: More than half of the stroke patients displayed (risk of) malnutrition, with higher prevalence in patient with OD vs. without OD. Fasted blood concentrations of vitamins B1, B2, B6, A, D, and E, selenium, choline, coenzyme Q10, albumin, pre-albumin, transferrin, docosahexaenoic acid, and eicosapentaenoic acid were all lower in stroke patients compared to their matched healthy reference subjects, irrespective of OD status. Reported energy, macronutrient, and water intake were lower in stroke patients vs. healthy reference subjects. As expected, quality of life and activities of daily living scores were lower in stroke vs. healthy reference subjects, with OD scoring worse than non-OD patients. Discussion: This study shows that malnutrition is highly prevalent in sub-acute stroke patients during rehabilitation. Even though patients with OD were more likely to be malnourished, blood levels of specific nutritional compounds were similarly lower in stroke patients with or without OD compared to healthy reference subjects. Furthermore, subgroup analysis showed similarly lower blood levels of specific nutritional compounds in patients that are normal nourished vs. patients with (risk of) malnutrition. This might imply disease-specific changes in blood levels on top of overall protein-energy malnutrition. The results of the current study underline that it is important to screen for nutritional impairments in every stroke patient, either with or without OD.