Cilius Esmann Fonvig1, Ingvild Dybdrodt Amundsen, Louise Kristine Vigsnæs, Nikolaj Sørensen, Christine Frithioff-Bøjsøe, Michael Christiansen, Paula Louise Hedley, Louise Aas Holm, Bruce McConnell, Jens-Christian Holm. 1. The Children's Obesity Clinic, accredited European Centre for Obesity Management, Department of Pediatrics, Copenhagen University Hospital Holbaek, Holbaek, Denmark The Novo Nordisk Foundation Center for Basic Metabolic Research, Section of Metabolic Genetics, University of Copenhagen, Copenhagen, Denmark Department of Pediatrics, Kolding Hospital a part of Lillebælt Hospital, Kolding, Denmark DSM, Hoersholm, Denmark Clinical Microbiomics, Copenhagen, Denmark Department for Congenital Disorders, Danish National Biobank and Biomarkers, Statens Serum Institut, Copenhagen, Denmark Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Abstract
OBJECTIVES: Human milk oligosaccharides (HMOs) impact the intestinal microbiota by increasing beneficial bacteria in infants and adults and are safe and well tolerated in these age groups. However, effects on intestinal microbiota, safety and digestive tolerance in children have not been assessed. The aims of this trial were to evaluate if HMOs are able to specifically modulate the intestinal microbiota in children, and to assess safety and digestive tolerance. METHODS: In this randomized, double-blinded, placebo-controlled trial, 75 children with overweight (including obesity) aged 6-12 years were randomized to receive 2'-fucosyllactose (2'FL), a mix of 2'FL and lacto-N-neotetraose (Mix), or a glucose placebo orally administrated once per day for eight weeks. RESULTS: The relative abundance of bifidobacteria increased significantly after four (p < 0.001) and eight (p = 0.025) weeks of intervention in the 2'FL-group and after four weeks (p = 0.033) in the Mix-group, whereas no change was observed in the placebo group. Compared to placebo, the 2'FL-group had a significant increase in bifidobacteria abundance after four weeks (p < 0.001) and eight weeks (p = 0.010) and the Mix-group showed a tendency to increased bifidobacteria abundance after four (p = 0.071) and eight weeks (p = 0.071). Bifidobacterium adolescentis drove the bifidogenic effect in the two groups. Biochemical markers indicated no safety concerns, and the products did not induce digestive tolerance issues as assessed by Gastrointestinal Symptoms Rating Scale and Bristol Stool Form Scale. CONCLUSIONS: Both 2'FL and the Mix beneficially modulate intestinal microbiota by increasing bifidobacteria. Furthermore, supplementation with either 2'FL alone or a Mix is safe and well tolerated in children.
RCT Entities:
OBJECTIVES:Human milk oligosaccharides (HMOs) impact the intestinal microbiota by increasing beneficial bacteria in infants and adults and are safe and well tolerated in these age groups. However, effects on intestinal microbiota, safety and digestive tolerance in children have not been assessed. The aims of this trial were to evaluate if HMOs are able to specifically modulate the intestinal microbiota in children, and to assess safety and digestive tolerance. METHODS: In this randomized, double-blinded, placebo-controlled trial, 75 children with overweight (including obesity) aged 6-12 years were randomized to receive 2'-fucosyllactose (2'FL), a mix of 2'FL and lacto-N-neotetraose (Mix), or a glucose placebo orally administrated once per day for eight weeks. RESULTS: The relative abundance of bifidobacteria increased significantly after four (p < 0.001) and eight (p = 0.025) weeks of intervention in the 2'FL-group and after four weeks (p = 0.033) in the Mix-group, whereas no change was observed in the placebo group. Compared to placebo, the 2'FL-group had a significant increase in bifidobacteria abundance after four weeks (p < 0.001) and eight weeks (p = 0.010) and the Mix-group showed a tendency to increased bifidobacteria abundance after four (p = 0.071) and eight weeks (p = 0.071). Bifidobacterium adolescentis drove the bifidogenic effect in the two groups. Biochemical markers indicated no safety concerns, and the products did not induce digestive tolerance issues as assessed by Gastrointestinal Symptoms Rating Scale and Bristol Stool Form Scale. CONCLUSIONS: Both 2'FL and the Mix beneficially modulate intestinal microbiota by increasing bifidobacteria. Furthermore, supplementation with either 2'FL alone or a Mix is safe and well tolerated in children.
Authors: Eveline Gart; Kanita Salic; Martine C Morrison; Martin Giera; Joline Attema; Christa de Ruiter; Martien Caspers; Frank Schuren; Ivana Bobeldijk-Pastorova; Marianne Heer; Yan Qin; Robert Kleemann Journal: Front Nutr Date: 2022-06-17
Authors: Cristina Iribarren; Maria K Magnusson; Louise K Vigsnæs; Imran Aziz; Ingvild Dybdrodt Amundsen; Tanja Šuligoj; Nathalie Juge; Piyush Patel; Maria Sapnara; Lea Johnsen; Nikolaj Sørensen; Johanna Sundin; Hans Törnblom; Magnus Simrén; Lena Öhman Journal: Nutrients Date: 2021-10-27 Impact factor: 5.717