Randomised trial · PloS one · 2016Conflicts declared

Isomaltulose formula and blood sugar in infants

Fleddermann M, Rauh-Pfeiffer A, Demmelmair H, Holdt L, Teupser D, Koletzko B · Free full text

In 50 infants, a follow-on formula with isomaltulose did not lower insulin 60 minutes after feeding, and blood sugar was actually higher than with a standard formula.

Both formulas were well accepted and tolerated.

What they found

Studies in people

Insulin at 60 minutes

Plasma insulin 60 minutes after feeding did not differ significantly between the two formula groups. Adjusted for age, time and volume of the test meal, insulin tended to be 2.60 μIU/mL higher in the isomaltulose group, but this was not statistically significant.

Blood sugar at 60 minutes

Blood sugar 60 minutes after feeding was higher in the isomaltulose group (median 122 mg/dL) than in the standard formula group (median 111 mg/dL). Adjusted for age, time and volume, blood sugar was 15.8 mg/dL higher with isomaltulose.

Urinary c-peptide

Urinary c-peptide and the c-peptide to creatinine ratio did not differ between the formula groups. The c-peptide to creatinine ratio was linked to total energy, protein and fat intake over the previous four days, but not to carbohydrate intake.

Acceptance and tolerance

Both formulas were well accepted. There were no differences in crying time, flatulence, stool characteristics or the number of adverse events between the groups.

Growth

Weight gain, length gain and head circumference gain did not differ significantly between the formula groups over the four weeks.

Other findings

Timing of blood sample

The authors suggest that in infants fed a liquid formula, peak blood sugar might be reached earlier than 60 minutes after the start of feeding. The single time point may have missed the peak for the isomaltulose formula and caught the fall for the standard formula.

What the authors conclude

“In conclusion, metabolic differences such as the expected reduced postprandial blood glucose and plasma insulin response were not observed.”

Fleddermann M, Rauh-Pfeiffer A, Demmelmair H, Holdt L, Teupser D, Koletzko B, 2016

Also in their conclusions

They conclude that the expected lower postprandial blood glucose and plasma insulin response was not observed.
They say this may be due to the limitations of the trial conditions in this age group, in particular blood collection at a single time point only, rather than the absence of difference.
They state that non-invasive urinary c-peptide measurements may be a suitable marker of nutritional intake during the previous four days in infants aged 4 to 8 completed months, and that both follow-on formulae were tolerated well and the isomaltulose formula was well accepted.

How it was done

Formula-fed infants have higher insulin levels than breast-fed infants, which has been linked to higher risk of obesity and type 2 diabetes later in life. Replacing high glycaemic maltodextrin with low glycaemic isomaltulose might reduce this insulin response.

Healthy term infants aged 4 to 8 completed months (n = 50) were randomised to receive a follow-on formula with 2.1 g isomaltulose per 100 mL or a standard formula with 2.1 g maltodextrin per 100 mL for four weeks. On day 29, after an overnight fast, they drank 100 to 120 mL of formula and a single blood sample was taken 60 minutes after the start of feeding.

What it can’t tell you

This trial measured blood sugar and insulin at only one time point, 60 minutes after feeding, so it cannot show what happened at other times.
The study lasted four weeks, so it cannot show any long-term effects on weight, obesity or diabetes risk.
The results are from a small group of 50 healthy infants, so they may not apply to all infants.

Who paid

Conflicts: 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.
Authors work at: University of Munich Medical Centre, Germany

The paper

Title: Effects of a Follow-On Formula Containing Isomaltulose (Palatinose™) on Metabolic Response, Acceptance, Tolerance and Safety in Infants: A Randomized-Controlled Trial
Type: Randomised controlled trial
Evidence: Studies in people
Summarised from: Full text
Licence: CC BY. Words in quotation marks are the authors’; the rest is our summary.
Cite: Fleddermann M, Rauh-Pfeiffer A, Demmelmair H, Holdt L, Teupser D, Koletzko B (2016). Effects of a Follow-On Formula Containing Isomaltulose (Palatinose™) on Metabolic Response, Acceptance, Tolerance and Safety in Infants: A Randomized-Controlled Trial. PloS one. doi:10.1371/journal.pone.0151614Free full text PubMed 26987056 DOI

Summary written 30 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error