Effects of a Follow-On Formula Containing Isomaltulose (Palatinose™) on Metabolic Response, Acceptance, Tolerance and Safety in Infants: A Randomized-Controlled Trial.

M. Fleddermann,H. Demmelmair,B. Koletzko,A. Rauh-Pfeiffer,D. Teupser,L. Holdt,Maciej Buchowski

doi:10.1371/journal.pone.0151614

Abstract

Effects of the dietary glycaemic load on postprandial blood glucose and insulin response might be of importance for fat deposition and risk of obesity. We aimed to investigate the metabolic effects, acceptance and tolerance of a follow-on formula containing the low glycaemic and low insulinaemic carbohydrate isomaltulose replacing high glycaemic maltodextrin. Healthy term infants aged 4 to 8 completed months (n = 50) were randomized to receive the intervention follow-on formula (IF, 2.1g isomaltulose (Palatinose™)/100mL) or an isocaloric conventional formula (CF) providing 2.1g maltodextrin/100mL for four weeks. Plasma insulinaemia 60min after start of feeding (primary outcome) was not statistically different, while glycaemia adjusted for age and time for drinking/volume of meal 60min after start of feeding was 122(105,140) mg/dL in IF (median, interquartile range) and 111(100,123) in CF (p = 0.01). Urinary c-peptide:creatinine ratio did not differ (IF:81.5(44.7, 96.0) vs. CF:56.8(37.5, 129),p = 0.43). Urinary c-peptide:creatinine ratio was correlated total intake of energy (R = 0.31,p = 0.045), protein (R = 0.42,p = 0.006) and fat (R = 0.40,p = 0.01) but not with carbohydrate intake (R = 0.22,p = 0.16). Both formulae were well accepted without differences in time of crying, flatulence, stool characteristics and the occurrence of adverse events. The expected lower postprandial plasma insulin and blood glucose level due to replacement of high glycaemic maltodextrin by low glycaemic isomaltulose were not observed in the single time-point blood analysis. In infants aged 4 to 8 completed months fed a liquid formula, peak blood glucose might be reached earlier than 60min after start of feeding. Non-invasive urinary c-peptide measurements may be a suitable marker of nutritional intake during the previous four days in infants.Trial registration: ClinicalTrials.gov NCT01627015

Highlights

In infants significantly higher insulin levels were observed in formula-fed compared to breastfed infants [1,2,3,4]
Insulin has been related to early weight gain [2], and higher insulin levels in formula-fed infants were found to be associated with higher risk of obesity and type 2 diabetes in later life compared to breast-fed infants [5,6]
The measurement of postprandial glycaemia at a single time point 60 min after the start of feeding resulted in significantly higher levels in intervention formula (IF) than in conventional formula (CF) infants

Summary

Introduction

In infants significantly higher insulin levels were observed in formula-fed compared to breastfed infants [1,2,3,4]. Differences in long-term outcomes between breast- and formula-fed infants can be related to e.g. the different protein content [7] and to the carbohydrate content of human milk and formula and its glycaemic and insulinaemic properties [8]. The replacement of conventional higher glycaemic carbohydrates (glycaemic index >70) such as maltodextrins by isomaltulose (PalatinoseTM, glycaemic index = 32, [9]) can lead to a follow-on formula with a lower glycaemic and insulinaemic response. The resulting postprandial glycaemia and insulinaemia following isomaltulose ingestion are lower as compared to usual disaccharides, while a higher blood glucose level is sustained for a longer period of time [9,11]

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