BACKGROUND: Human breastmilk contains gangliosides which may play an important role in infant neurodevelopment. AIM: A pilot study was conducted to assess the impact of infant formula supplemented with gangliosides from complex milk lipid on cognitive functions of normal healthy infants. STUDY DESIGN: The study was a double-blind, randomized, controlled, parallel group clinical trial in which infants received the treatment or control product from 2 to 8 weeks of age until 24 weeks of age. The control group (n=30) received standard infant formula and the treatment group (n=29) received the same formula supplemented with complex milk lipid to increase the ganglioside content to approximately 11 to 12 μg/ml. A reference group (n=32) consisted of normal healthy exclusively breast-fed infants. OUTCOME MEASURES: Cognitive development using the Griffith Scales and serum gangliosides was measured before (2-8 weeks of age) and after intervention (24 weeks of age). RESULTS: Ganglioside supplementation using complex milk lipids significantly increased ganglioside serum levels (control group vs treatment group, P=0.002) and resulted in increased scores for Hand and Eye coordination IQ (P<0.006), Performance IQ (P<0.001) and General IQ (P=0.041). Cognitive development scores and serum ganglioside levels for the treatment group did not differ from the reference group. CONCLUSIONS: Supplementation of infant formula with complex milk lipid to enhance ganglioside content appears to have beneficial effects on cognitive development in healthy infants aged 0-6 months, which may be related to increased serum ganglioside levels.
RCT Entities:
BACKGROUND:Human breastmilk contains gangliosides which may play an important role in infant neurodevelopment. AIM: A pilot study was conducted to assess the impact of infant formula supplemented with gangliosides from complex milk lipid on cognitive functions of normal healthy infants. STUDY DESIGN: The study was a double-blind, randomized, controlled, parallel group clinical trial in which infants received the treatment or control product from 2 to 8 weeks of age until 24 weeks of age. The control group (n=30) received standard infant formula and the treatment group (n=29) received the same formula supplemented with complex milk lipid to increase the ganglioside content to approximately 11 to 12 μg/ml. A reference group (n=32) consisted of normal healthy exclusively breast-fed infants. OUTCOME MEASURES: Cognitive development using the Griffith Scales and serum gangliosides was measured before (2-8 weeks of age) and after intervention (24 weeks of age). RESULTS:Ganglioside supplementation using complex milk lipids significantly increased ganglioside serum levels (control group vs treatment group, P=0.002) and resulted in increased scores for Hand and Eye coordination IQ (P<0.006), Performance IQ (P<0.001) and General IQ (P=0.041). Cognitive development scores and serum ganglioside levels for the treatment group did not differ from the reference group. CONCLUSIONS: Supplementation of infant formula with complex milk lipid to enhance ganglioside content appears to have beneficial effects on cognitive development in healthy infants aged 0-6 months, which may be related to increased serum ganglioside levels.
Authors: Ilse A C Arnoldussen; Martine C Morrison; Maximilian Wiesmann; Janna A van Diepen; Nicole Worms; Marijke Voskuilen; Vivienne Verweij; Bram Geenen; Natàlia Pujol Gualdo; Lonneke van der Logt; Gabriele Gross; Robert Kleemann; Amanda J Kiliaan Journal: Int J Obes (Lond) Date: 2021-10-29 Impact factor: 5.095