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

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

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 60 min after start of feeding (primary outcome) was not statistically different, while glycaemia adjusted for age and time for drinking/volume of meal 60 min 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 60 min 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.

Conflict of interest statement

Competing Interests: The authors have the following interests: The study was financially supported by BENEO GmbH (Mannheim, Germany), a member of the Suedzucker Group. BENEO supplied the respective formulae and reserves the exclusive right to use the results and data for possible Health Claim requests. Isomaltulose as part of one of the authors' formulas is already on the market. A follow-on formula including isomaltulose, which is used in the study, is not on the market. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Fig 1. CONSORT chart.
Fig 1. CONSORT chart.
Numbers of participants for randomization, allocation, follow-up and analysis of low glycaemic intervention formula and conventional higher glycaemic formula group.

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