No effect of adding dairy lipids or long chain polyunsaturated fatty acids on formula tolerance and growth in full term infants: a randomized controlled trial

Maria Lorella Gianni, Paola Roggero, Charlotte Baudry, Catherine Fressange-Mazda, Pascale le Ruyet, Fabio Mosca, Maria Lorella Gianni, Paola Roggero, Charlotte Baudry, Catherine Fressange-Mazda, Pascale le Ruyet, Fabio Mosca

Abstract

Background: When breastfeeding is not possible, infants are fed formulas in which lipids are usually of plant origin. However, the use of dairy fat in combination with plant oils enables a lipid profile in formula closer to breast milk in terms of fatty acid composition, triglyceride structure and cholesterol content. The objectives of this study were to investigate the impact on growth and gastrointestinal tolerance of a formula containing a mix of dairy lipids and plant oils in healthy infants.

Methods: This study was a monocentric, double-blind, controlled, randomized trial. Healthy term infants aged less than 3 weeks whose mothers did not breastfeed were randomly allocated to formula containing either: a mix of plant oils and dairy fat (D), only plant oils (P) or plant oils supplemented with long-chain polyunsaturated fatty acids (PDHA). Breastfed infants were included in a reference group (BF). Anthropometric parameters and body composition were measured after 2 and 4 months. Gastrointestinal tolerance was evaluated during 2 day-periods after 1 and 3 months thanks to descriptive parameters reported by parents. Nonrandomized BF infants were not included in the statistical analysis.

Results: Eighty eight formula-fed and 29 BF infants were enrolled. Gains of weight, recumbent length, cranial circumference and fat mass were similar between the 3 formula-fed groups at 2 and 4 months and close to those of BF. Z-scores for weight, recumbent length and cranial circumference in all groups were within normal ranges for growth standards. No significant differences were noted among the 3 formula groups in gastrointestinal parameters (stool frequency/consistency/color), occurrence of gastrointestinal symptoms (abdominal pain, flatulence, regurgitation) or infant's behavior.

Conclusions: A formula containing a mix of dairy lipids and plant oils enables a normal growth in healthy newborns. This formula is well tolerated and does not lead to abnormal gastrointestinal symptoms. Consequently, reintroduction of dairy lipids could represent an interesting strategy to improve lipid quality in infant formulas.

Trial registration: ClinicalTrials.gov Identifier NCT01611649 , retrospectively registered on May 25, 2012.

Keywords: Body composition; Dairy fat; Dairy lipids; Fat mass; Fatty acids; Gastrointestinal tolerance; Growth; Infant formula; Lipid quality; Regurgitation.

Conflict of interest statement

Ethics approval and consent to participate

This study was approved by the local Ethical Committee of the Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, Italy and conducted in accordance with Good Clinical Practice and the principles and rules of the Declaration of Helsinki. Parents or legal caregivers provided written informed consent prior to enrollment of their infants in the study.

Consent for publication

Not applicable.

Competing interests

This study was funded by Lactalis Nutrition Europe, Torcé, France. Study formulas were provided by Milumel®, Lactalis, Craon, France. CB, CFM and PLR are employees of the Lactalis group, France. MLG is a member of the editorial board of BMC Pediatrics.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow of study subjects. Formula D contained a mixture of dairy lipids and plant oils; formula P contained only plant oils and formula PDHA contained plant oils supplemented with ARA and DHA. GI (gastrointestinal) symptoms included regurgitations, reflux, constipation, abdominal pain and flatulence
Fig. 2
Fig. 2
Mean growth measurements of infants relative to WHO growth standards. Formula D contained a mixture of dairy lipids and plant oils; formula P contained only plant oils and formula PDHA contained plant oils supplemented with ARA and DHA. WHO: World Health Organization
Fig. 3
Fig. 3
Body composition expressed in percentage of body weight at baseline, 2 months and 4 months in formula-fed and breastfed infants. Formula D contained a mixture of dairy lipids and plant oils; formula P contained only plant oils and formula PDHA contained plant oils supplemented with ARA and DHA. BW: body weight. Comparison of the 3 formula group by ANOVA 3 fixed factors (Sex, Time, Formula and all interactions)
Fig. 4
Fig. 4
Infants’ stool frequency, consistency and color at 1 and 3 months of age. Formula D contained a mixture of dairy lipids and plant oils; formula P contained only plant oils and formula PDHA contained plant oils supplemented with ARA and DHA. BF: breastfed. Comparison of the 3 formula group by ordinal logistic model on formula and time effects with age as covariate
Fig. 5
Fig. 5
Description of regurgitations and vomits in infants at 1 (left) and 3 months (right). Formula D contained a mixture of dairy lipids and plant oils; formula P contained only plant oils and formula PDHA contained plant oils supplemented with ARA and DHA. Comparison of the 3 formula group by binary logistic model on formula and time effects with age as covariate

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