Trial reportThe journal of nutrition, health & aging2016
Gastro-Intestinal Tolerance and Renal Safety of Protein Oral Nutritional Supplements in Nursing Home Residents: A Randomized Controlled Trial.
Trial report in The journal of nutrition, health & aging, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed, 5 citations in OpenAlex.
- The influence of patients' nutritional risk, nutritional status, and energy density in MEDPass versus conventional administration of oral nutritional supplements - A secondary analysis of a randomized controlled trial.The journal of nutrition, health & aging · 2024Trial
- Safety and tolerability of 6-month supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink in sarcopenic older adults.Aging clinical and experimental research · 2020Trial
- A multi-center prospective study of plant-based nutritional support in adult community-based patients at risk of disease-related malnutrition.Frontiers in nutrition · 2023Article
Corrections and comments
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Authors and funding
7 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
objectiveHigh protein oral nutritional supplements (ONS) are regularly prescribed to undernourished patients; however usage of these in older adults is being discussed, as their renal function might have declined with age. Therefore, the aim of the current study was to evaluate the effects of 8 week long consumption of high protein ONS on the renal function of nursing home residents in need of supplementation. Furthermore, within the same setup, differences in gastro-intestinal tolerance between a standard and a more concentrated version of an ONS were investigated.
designRandomized, controlled, single-blind, parallel-group, multi-country trial (NTR2565).
settingNursing home.
participants67 nursing home residents in need of ONS (energy-dense, small volume group n=32; standard volume group n=35).
interventionProtein supplementation was provided by either a standard (200ml, 300kcal, 20g protein) or an energy-dense, small volume (125ml, 300kcal, 18g protein) ONS during the 8 week long study. MEASUREMENTS: Primary outcome was gastro-intestinal tolerance, assessed by daily stool frequency and consistency, and occurrence and intensity of self-reported gastro-intestinal symptoms. Safety was measured via the occurrence of (serious) adverse events, vital signs, as well as liver- and kidney function monitoring.
resultsNo clinically relevant and, except for flatulence, no statistically significant differences in gastro-intestinal tolerance were observed between groups. No significant difference between groups was found for estimated glomerular filtration rate (eGFR) and urinary albumin/creatinine ratio at baseline and week 8, nor for the changes from baseline. Adverse events and the changes in monitored renal parameters over the study period did not point to a deterioration of renal function.
conclusionHigh protein ONS seems to be well-tolerated and safe; there is no indication that it affects renal function in nursing home residents, including patients with stage 3 chronic kidney disease, under the conditions tested. Results did not suggest a difference in the effect on renal function between standard and energy-dense small volume ONS format.
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