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Clinical Trial
. 2017 Sep;23(3):203-209.
doi: 10.1177/0260106017729959.

Moderately high-protein enteral formula improved retinol-binding protein in tube-fed patients: A multicentre open study

Veeradej Pisprasert  1 , Prapimporn Chattranukulchai Shantavasinkul  2 , Sornwichate Rattanachaiwong  1 , Tanarat Lepananon  2 , Surat Komindr  2
Affiliations
Clinical Trial

Moderately high-protein enteral formula improved retinol-binding protein in tube-fed patients: A multicentre open study

Veeradej Pisprasert et al. Nutr Health. 2017 Sep.

Abstract

Background: Long-term inadequate dietary consumption may increase the possibility of malnutrition, morbidity and mortality. Enteral nutrition (EN) is a beneficial support that could help to maintain nutritional status and gut function.

Aim: Our aim was to evaluate the effect of moderately high-protein enteral formula containing fibre on nutritional status, and its safety.

Method: A total of 23 tube-feeding-dependent adult patients were included in this multicentre, open-label study. The patients were fed with the study formula for 7-12 days or equal to the required nutritional support period, during which we performed physical examinations and assessed nutritional status. The primary endpoint was the statistical difference in nutritional status after the treatment, and the secondary outcome was the desirable safety profile.

Results: A significant improvement in cumulative energy balance after intervention was observed ( p = 0.008). However, the differences in nutritional status, weight and BMI before and after the intervention do not reach statistical significance. Retinol-binding protein (RBP), a marker for nutritional status, increased from baseline levels. Few cases of diarrhoea and constipation had been reported during the study as a safety concern.

Conclusions: This study investigated the efficacy and safety of an enteral feed formulation containing fibre. The patients were nourished with the studied formulation via tube feeding for a short period without serious adverse events. After the intervention, the significant increase in cumulative energy balance was observed. However, an extended period of the intervention may be required to attain the significance in other indicators for nutritional status.

Keywords: High-protein formulas; enteral nutrition; open-label study; retinol-binding protein; tube-feeding.

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Conflict of interest statement

Declaration of conflicting interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Mean values of cumulative energy balance (kcal) on different days of the intervention. The data are presented as mean ± standard error.
Figure 2.
Figure 2.
Nitrogen balance during the study. Nitrogen balance during the study tended to increase after receiving the study diet. N: nitrogen; BS: baseline; MR: maintenance phase.
Figure 3.
Figure 3.
Change in visceral protein markers (RBP level) at different stages of the intervention. BS: baseline; IR: initial phase; MR: maintenance phase.
See this image and copyright information in PMC

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