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Safety and tolerance evaluation of milk fat globule membrane-enriched infant formulas: a randomized controlled multicenter non-inferiority trial in healthy term infants.

Billeaud C, Puccio G, Saliba E, Guillois B, Vaysse C, Pecquet S, Steenhout P - Clin Med Insights Pediatr (2014)

Bottom Line: This multicenter non-inferiority study evaluated the safety of infant formulas enriched with bovine milk fat globule membrane (MFGM) fractions.Weight gain was non-inferior in the MFGM-L and MFGM-P groups compared with the control group.Both MFGM-enriched formulas met the primary safety endpoint of non-inferiority in weight gain and were generally well tolerated, although a higher rate of eczema was observed in the MFGM-P group.

View Article: PubMed Central - PubMed

Affiliation: Nutrition and Neonatologie, CIC 005 Peditrique INSERM, CHU Bordeaux, Bordeaux, France.

ABSTRACT

Objective: This multicenter non-inferiority study evaluated the safety of infant formulas enriched with bovine milk fat globule membrane (MFGM) fractions.

Methods: Healthy, full-term infants (n = 119) age ≤14 days were randomized to standard infant formula (control), standard formula enriched with a lipid-rich MFGM fraction (MFGM-L), or standard formula enriched with a protein-rich MFGM fraction (MFGM-P). Primary outcome was mean weight gain per day from enrollment to age 4 months (non-inferiority margin: -3.0 g/day). Secondary (length, head circumference, tolerability, morbidity, adverse events) and exploratory (phospholipids, metabolic markers, immune markers) outcomes were also evaluated.

Results: Weight gain was non-inferior in the MFGM-L and MFGM-P groups compared with the control group. Among secondary and exploratory outcomes, few between-group differences were observed. Formula tolerance rates were high (>94%) in all groups. Adverse event and morbidity rates were similar across groups except for a higher rate of eczema in the MFGM-P group (13.9% vs control [3.5%], MFGM-L [1.4%]).

Conclusion: Both MFGM-enriched formulas met the primary safety endpoint of non-inferiority in weight gain and were generally well tolerated, although a higher rate of eczema was observed in the MFGM-P group.

No MeSH data available.


Related in: MedlinePlus

Weight-for-age z-scores (WHO) in males and females in the ITT population.
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f2-cmped-8-2014-051: Weight-for-age z-scores (WHO) in males and females in the ITT population.

Mentions: In both MFGM groups, the lower bound of the 95% CI for difference in weight gain vs control was greater than the non-inferiority margin of −3.0 g/day. The difference in mean weight gain between the MFGM-L group and the control group was −0.8 g/day (95% CI, −2.81 to 1.22). The difference between the MFGM-P group and the control group was −0.65 g/day (95% CI, −2.66 to 1.36). Weight z-scores were within −1.0 to +1.0 throughout the study in all three groups, indicating normal growth, with no significant differences observed between groups (Fig. 2). Similarly, there were no significant differences between the MFGM-enriched and control formula groups in length or head circumference gains over the course of the study, and length (Fig. 3) and head circumference (Fig. 4) z-scores were within −1.0 to +1.0 throughout the study.


Safety and tolerance evaluation of milk fat globule membrane-enriched infant formulas: a randomized controlled multicenter non-inferiority trial in healthy term infants.

Billeaud C, Puccio G, Saliba E, Guillois B, Vaysse C, Pecquet S, Steenhout P - Clin Med Insights Pediatr (2014)

Weight-for-age z-scores (WHO) in males and females in the ITT population.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4219856&req=5

f2-cmped-8-2014-051: Weight-for-age z-scores (WHO) in males and females in the ITT population.
Mentions: In both MFGM groups, the lower bound of the 95% CI for difference in weight gain vs control was greater than the non-inferiority margin of −3.0 g/day. The difference in mean weight gain between the MFGM-L group and the control group was −0.8 g/day (95% CI, −2.81 to 1.22). The difference between the MFGM-P group and the control group was −0.65 g/day (95% CI, −2.66 to 1.36). Weight z-scores were within −1.0 to +1.0 throughout the study in all three groups, indicating normal growth, with no significant differences observed between groups (Fig. 2). Similarly, there were no significant differences between the MFGM-enriched and control formula groups in length or head circumference gains over the course of the study, and length (Fig. 3) and head circumference (Fig. 4) z-scores were within −1.0 to +1.0 throughout the study.

Bottom Line: This multicenter non-inferiority study evaluated the safety of infant formulas enriched with bovine milk fat globule membrane (MFGM) fractions.Weight gain was non-inferior in the MFGM-L and MFGM-P groups compared with the control group.Both MFGM-enriched formulas met the primary safety endpoint of non-inferiority in weight gain and were generally well tolerated, although a higher rate of eczema was observed in the MFGM-P group.

View Article: PubMed Central - PubMed

Affiliation: Nutrition and Neonatologie, CIC 005 Peditrique INSERM, CHU Bordeaux, Bordeaux, France.

ABSTRACT

Objective: This multicenter non-inferiority study evaluated the safety of infant formulas enriched with bovine milk fat globule membrane (MFGM) fractions.

Methods: Healthy, full-term infants (n = 119) age ≤14 days were randomized to standard infant formula (control), standard formula enriched with a lipid-rich MFGM fraction (MFGM-L), or standard formula enriched with a protein-rich MFGM fraction (MFGM-P). Primary outcome was mean weight gain per day from enrollment to age 4 months (non-inferiority margin: -3.0 g/day). Secondary (length, head circumference, tolerability, morbidity, adverse events) and exploratory (phospholipids, metabolic markers, immune markers) outcomes were also evaluated.

Results: Weight gain was non-inferior in the MFGM-L and MFGM-P groups compared with the control group. Among secondary and exploratory outcomes, few between-group differences were observed. Formula tolerance rates were high (>94%) in all groups. Adverse event and morbidity rates were similar across groups except for a higher rate of eczema in the MFGM-P group (13.9% vs control [3.5%], MFGM-L [1.4%]).

Conclusion: Both MFGM-enriched formulas met the primary safety endpoint of non-inferiority in weight gain and were generally well tolerated, although a higher rate of eczema was observed in the MFGM-P group.

No MeSH data available.


Related in: MedlinePlus