Energy-dense, low-volume paediatric oral nutritional supplements improve total nutrient intake and increase growth in paediatric patients requiring nutritional support: results of a randomised controlled pilot trial

Gary P Hubbard, Catherine Fry, Katy Sorensen, Catherine Casewell, Lydia Collins, Annaruby Cunjamalay, Michelle Simpson, Amanda Wall, Elmarie Van Wyk, Matthew Ward, Sophie Hallowes, Hannah Duggan, Jennifer Robison, Helen Gane, Lucy Pope, Jennifer Clark, Rebecca J Stratton, Gary P Hubbard, Catherine Fry, Katy Sorensen, Catherine Casewell, Lydia Collins, Annaruby Cunjamalay, Michelle Simpson, Amanda Wall, Elmarie Van Wyk, Matthew Ward, Sophie Hallowes, Hannah Duggan, Jennifer Robison, Helen Gane, Lucy Pope, Jennifer Clark, Rebecca J Stratton

Abstract

Children with or at risk of faltering growth require nutritional support and are often prescribed oral nutritional supplements (ONS). This randomised controlled trial investigated the effects of energy-dense paediatric ONS (2.4 kcal/ml, 125 ml: cONS) versus 1.5 kcal/ml, 200 ml ONS (sONS) in community-based paediatric patients requiring oral nutritional support. Fifty-one patients (mean age 5.8 years (SD 3)) with faltering growth and/or requiring ONS to meet their nutritional requirements were randomised to cONS (n = 27) or sONS (n = 24) for 28 days. Nutrient intake, growth, ONS compliance and acceptability, appetite and gastro-intestinal tolerance were assessed. Use of the cONS resulted in significantly greater mean total daily energy (+ 531 kcal/day), protein (+ 10.1 g/day) and key micronutrient intakes compared with the sONS group at day 28 and over time, due to high ONS compliance (81% of patients ≥ 75%), maintained intake from diet alone and improved appetite in the cONS group, compared with the sONS group. Although growth increased in both intervention groups, results were significant in the cONS group (weight (p = 0.007), height (p < 0.001) and height z-score (p = 0.006)).Conclusions: This study shows that use of energy-dense (2.4 kcal/ml) low-volume paediatric-specific ONS leads to improved nutrient intakes, growth and appetite in paediatric patients requiring oral nutrition support compared with standard energy density ONS.Trial registration: The trial is registered at clinicaltrials.gov , identification number NCT02419599. What is Known: • Faltering growth is the failure of children to achieve adequate growth at a normal rate for their age and requires nutritional support, including the use of oral nutritional supplements (ONS). • Energy-dense, low-volume ONS have benefits over standard ONS in adults. What is New: • This is the first RCT to investigate the effects of energy-dense, low-volume ONS (2.4 kcal/ml, 125 ml) in children with faltering growth, showing significant improvements in total nutrient intake and increased growth. • Energy-dense, low-volume ONS can play a key role in the management of faltering growth.

Keywords: Faltering; Growth; Intake; Nutrition; Oral; Paediatric.

Conflict of interest statement

G.P. Hubbard, C. Fry, K. Sorensen and R.J. Stratton are employees of Nutricia Ltd UK. No other conflicts of interest are declared.

Figures

Fig. 1
Fig. 1
Flow chart of study exclusions and participation
Fig. 2
Fig. 2
Mean daily energy (a) and protein (b) intakes are higher with cONS than with sONS at day 28 (intake from diet: white bar; intake from ONS: black bar. Total value provided above bar

References

    1. Alarcon PA, Lin LH, Noche M, Jr, Hernandez VC, Cimafranca L, Lam W, Comer GM. Effect of oral supplementation on catch-up growth in picky eaters. Clin Pediatr (Phila) 2003;42(3):209–217.
    1. Barnard J, Rubin DB. Small-sample degrees of freedom with multiple imputation. Biometrika. 1999;86(4):948–955.
    1. Bell EA, Castellanos VH, Pelkman CL, Thorwart ML, Rolls BJ. Energy density of foods affects energy intake in normal-weight women. Am J Clin Nutr. 1998;67(3):412–420.
    1. Black MM, Dubowitz H, Krishnakumar A, Starr RH., Jr Early intervention and recovery among children with failure to thrive: follow-up at age 8. Pediatrics. 2007;120(1):59–69.
    1. Cawood AL, Elia M, Freeman R, Stratton RJ (2008) Systematic review and meta-analysis of the effects of high-protein oral nutritional supplements on healthcare use. Proceedings of the Nutrition Society 67 (OCE4) 10.1017/S0029665108007507
    1. Cawood AL, Elia M, Stratton RJ. Meta-analysis shows reduced health care use and costs with oral nutritional supplements. Clin Nutr Suppl. 2010;5:123.
    1. Cawood AL, Smith TR, Guildford N, Wood C, Ashbolt K, Walters ER, Stratton RJ. Low volume energy dense oral nutritional supplements improve micronutrient intakes in free living malnourished older people; a randomised trial. Clin Nutr. 2017;36:S175–S176.
    1. de Castro JM. Macronutrient and dietary energy density influences on the intake of free-living humans. Appetite. 2006;46(1):1–5.
    1. DoH (1991) Dietary reference values for food energy and nutrients for the United Kingdom. Report of the Panel on Dietary Reference Values of the Committee on Medical Aspects of Food Policy HMSO, London
    1. Elia M, Parsons EL, Cawood AL, Smith TR, Stratton RJ. Cost-effectiveness of oral nutritional supplements in older malnourished care home residents. Clin Nutr. 2017;37(2):651–658.
    1. Evans S, Daly A, Davies P, MacDonald A. The nutritional intake supplied by enteral formulae used in older children (aged 7-12 years) on home tube feeds. J Hum Nutr Diet. 2009;22(5):394–399.
    1. Fiore P, Castagnola E, Merolla R. Effect of nutritional intervention on physical growth in children at risk of malnutrition. Int Pediatr. 2002;17(3):179–183.
    1. Freeman R, Ralph AF, Cawood AL, Stratton RJ (2011) A survey of compliance and use of ready-made liquid oral nutritional supplements in elderly malnourished care home residents. Aging Clin Exp Res 23 (Suppl to No.1):159
    1. Grogan J, Watling R, Davey T, Maclean A, Cairns L, Dunlop C, Cawood AL. Gastrointestinal tolerance of two fibre enriched paediatric enteral tube feeds. J Hum Nutr Diet. 2006;19(6):462.
    1. Gurlek Gokcebay D, Emir S, Bayhan T, Demir HA, Gunduz M, Tunc B. Assessment of nutritional status in children with cancer and effectiveness of oral nutritional supplements. Pediatr Hematol Oncol. 2015;32(6):423–432.
    1. Hubbard GP, Holdoway A, Stratton RJ. A pilot study investigating compliance and efficacy of a novel, low volume, energy dense (2.4kcal/ml) multi-nutrient supplement in malnourished community patients. Clin Nutr Suppl. 2009;4(2):41.
    1. Hubbard GP, Buchan B, Sanders K, Brothers S, Stratton RJ. Improved compliance and increased intake of energy and protein with a high energy density, low volume multi-nutrient supplement. Proc Nutr Soc. 2010;69(OCE 2):E164.
    1. Hubbard GP, Elia M, Holdoway A, Stratton RJ. A systematic review of compliance to oral nutritional supplements. Clin Nutr. 2012;31(3):293–312.
    1. Joosten K, Meyer R. Nutritional screening and guidelines for managing the child with faltering growth. Eur J Clin Nutr. 2010;64(Suppl 1):S22–S24.
    1. Kasese-Hara M, Wright C, Drewett R. Energy compensation in young children who fail to thrive. J Child Psychol Psychiatry. 2002;43(4):449–456.
    1. King C, Davis T. Nutritional treatment of infants and children with faltering growth. Eur J Clin Nutr. 2010;64(Suppl 1):S11–S13.
    1. Kral TV, Rolls BJ. Energy density and portion size: their independent and combined effects on energy intake. Physiol Behav. 2004;82(1):131–138.
    1. Krugman SD, Dubowitz H. Failure to thrive. Am Fam Physician. 2003;68(5):879–884.
    1. Liang R, Chen GY, Fu SX, Zhong J, Ma Y. Benefit of oral nutritional supplements for children with acute lymphoblastic leukaemia during remission-induction chemotherapy: a quasi-experimental study. Asia Pac J Clin Nutr. 2018;27(1):144–147.
    1. NICE . Faltering growth - recognition and management. London: National Institute for Health and Care Excellence (UK); 2017.
    1. Parsons EL, Elia M, Cawood AL, Smith TR, Warwick H, Stratton RJ. Randomised controlled trial in care home residents shows improved quality of life (QOL) with oral nutritional supplements. Clin Nutr Suppl. 2011;6(1):31.
    1. Pocock SJ (1999) Clinical trials: a practical approach. John Wiley and Sons, Chichester, UK
    1. Rolls BJ. The relationship between dietary energy density and energy intake. Physiol Behav. 2009;97:609–615.
    1. Rolls BJ, Castellanos VH, Halford JC, Kilara A, Panyam D, Pelkman CL, Smith GP, Thorwart ML. Volume of food consumed affects satiety in men. Am J Clin Nutr. 1998;67(6):1170–1177.
    1. Rolls BJ, Bell EA, Castellanos VH, Chow M, Pelkman CL, Thorwart ML. Energy density but not fat content of foods affected energy intake in lean and obese women. Am J Clin Nutr. 1999;69(5):863–871.
    1. Romano C, van Wynckel M, Hulst J, Broekaert I, Bronsky J, Dall’Oglio L, Mis NF, Hojsak I, Orel R, Papadopoulou A, Schaeppi M, Thapar N, Wilschanski M, Sullivan P, Gottrand F. European Society for Paediatric Gastroenterology, Hepatology and nutrition guidelines for the evaluation and treatment of gastrointestinal and nutritional complications in children with neurological impairment. J Pediatr Gastroenterol Nutr. 2017;65(2):242–264.
    1. Rubin DB. Multiple imputation for nonresponse in surveys. New York: John Wiley and Sons; 2004.
    1. Schrezenmeir J, Heller K, McCue M, Llamas C, Lam W, Burow H, Kindling-Rohracker M, Fischer W, Sengespeik HC, Comer GM, Alarcon P. Benefits of oral supplementation with and without synbiotics in young children with acute bacterial infections. Clin Pediatr (Phila) 2004;43(3):239–249.
    1. Sheng X, Tong M, Zhao D, Leung TF, Zhang F, Hays NP, Ge J, Ho WM, Northington R, Terry DL, Yao M. Randomized controlled trial to compare growth parameters and nutrient adequacy in children with picky eating behaviors who received nutritional counseling with or without an oral nutritional supplement. Nutr MetabInsights. 2014;7:85–94.
    1. Shields B, Wacogne I, Wright CM. Weight faltering and failure to thrive in infancy and early childhood. BMJ. 2012;345:e5931.
    1. Skypala I, Ashworth A, Hodson M, Leonard C, Knox A, Hiller E, Wolfe S, Littlewood J, Morton A, Conway S, Patchell C, Weller P, McCarthy H, Redmond A, Dodge J. Oral nutritional supplements promote significant weight gain in cystic fibrosis patients. J Hum Nutr Diet. 1998;11(2):95–104.
    1. Smith C, Cawood AL, Jenkins C, Ralph A, Neville C, Lowdon J, S RJ. Review of use and compliance with oral nutritional supplements in dietetic paediatric outpatient clinics. J Hum Nutr Diet. 2009;22(6):606–607.
    1. Smith TR, Guildford N, Cawood AL, Walters ER, Cotton J, Stratton RJ (2018) Randomised controlled trial shows ready-made low volume energy dense oral nutritional supplements reduce health care use in malnourished free living older people. J Parenter Enter Nutr 42(2) S43
    1. Smith T, Cawood AL, Guildford N, Stratton RJ. Randomized trial shows low volume energy dense oral nutritional supplements improve total nutritional intake with little suppression of food intake in malnurished free living older people. Clin Nutr. 2018;37:S7.
    1. Standardized Height and Weight Z-score Calculator . 2018
    1. Stange I, Bartram M, Liao Y, Pöschl K, Stehle P, Sieber CC, Volkert D. Low volume, energy- and nutrient-dense oral nutritional supplement improves nutritional status of nursing home residents. Clin Nutr Suppl. 2011;6(1):127–128.
    1. Stange I, Bartram M, Liao Y, Pöschl K, Stehle P, Sieber CC, Volkert D. Effects of a low-volume, nutrient- and energy-dense oral nutritional supplement on nutritional and functional status: a randomized, controlled trial in nursing home residents. J Am Med Dir Assoc. 2013;14(8):628.e621–628.e628.
    1. Steinkamp G, Demmelmair H, Ruhl-Bagheri I, von der Hardt H, Koletzko B. Energy supplements rich in linoleic acid improve body weight and essential fatty acid status of cystic fibrosis patients. J Pediatr Gastroenterol Nutr. 2000;31(4):418–423.
    1. Sterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, Wood AM, Carpenter JR. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. Br Med J. 2009;338:b2393.
    1. Stratton RJ, Elia M. A critical, systematic analysis of the use of oral nutritional supplements in the community. Clin Nutr. 1999;18(Supp2):29–84.
    1. Stratton RJ, Elia M. Are oral nutritional supplements of benefit to patients in the community? Findings from a systematic review. Curr Opin Clin Nutr Metab Care. 2000;3(4):311–315.
    1. Stratton RJ, Elia M. A review of reviews: a new look at the evidence for oral nutritional supplements in clinical practice. Clin Nutr Suppl. 2007;2:5–23.
    1. Stratton RJ, Elia M. Encouraging appropriate, evidence-based use of oral nutritional supplements. Proc Nutr Soc. 2010;69(4):477–487.
    1. Stratton RJ, Green CJ, Elia M. Disease-related malnutrition: an evidence-based approach to treatment. Oxford: CABI publishing; 2003.
    1. Stratton R, Hebuterne X, Elia M. Systematic review and meta-analysis of the effects of oral nutritional supplements on hospital admissions. Ageing Res Rev. 2013;12(4):884–897.
    1. Walters ER, Cawood AL, Smith TR, Guildford N, Stratton RJ (2018) Compliance, acceptability and satisfaction with low volume oral nutritional supplements: results from a randomised trial in malnourished free living older people Clinical Nutrition 37 Supp 1 S94
    1. Watling R, Grogan J, Larmour K, Court-Brown F, Davidson C, Cooke S, Bolch R, Sijben JW, Dhawan A (2008) Gastrointestinal tolerance and convenience of a new ready-to-use paediatric peptide feed. BSPGHAN Annual Winter Conference
    1. Wright CM. Identification and management of failure to thrive: a community perspective. Arch Dis Child. 2000;82(1):5–9.

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다