title: Effects of Fructans from Mexican Agave in Newborns Fed with Infant Formula: A Randomized Controlled Trial.
abstract: BACKGROUND
  The importance of prebiotics consumption is increasing all over the world due to their beneficial effects on health. Production of better prebiotics from endemic plants raises possibilities to enhance nutritional effects in vulnerable population groups. Fructans derived from Agave Plant have demonstrated their safety and efficacy as prebiotics in animal models. Recently, the safety in humans of two fructans obtained from Agave tequilana (Metlin(®) and Metlos(®)) was demonstrated.
  
  
  METHODS
  This study aimed to demonstrate the efficacy as prebiotics of Metlin(®) and Metlos(®) in newborns of a randomized, double blind, controlled trial with a pilot study design. Biological samples were taken at 20 ± 7 days, and three months of age from healthy babies. Outcomes of efficacy include impact on immune response, serum ferritin, C-reactive protein, bone metabolism, and gut bacteria changes.
  
  
  RESULTS
  There were differences statistically significant for the groups of infants fed only with infant formula and with formula enriched with Metlin(®) and Metlos(®).
  
  
  CONCLUSIONS
  Our results support the efficacy of Metlin(®) and Metlos(®) as prebiotics in humans, and stand the bases to recommend their consumption.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT 01251783.
authors.affiliation: Laboratorio de Bioquímica-Genética, Instituto Nacional de Pediatría, Mexico City 04530, México. glv_1999@yahoo.com.
authors.forename: Gabriel
authors.initials: G
authors.lastname: López-Velázquez
authors.affiliation: Hospital General de México Dr. Eduardo Liceaga, Mexico City 06726, México. md_parra@hotmail.com.|Urgencias Pediatría, Centro Médico ABC, Santa Fe 05300, México. md_parra@hotmail.com.
authors.forename: Minerva
authors.initials: M
authors.lastname: Parra-Ortiz
authors.affiliation: Laboratorio de Bioquímica-Genética, Instituto Nacional de Pediatría, Mexico City 04530, México. ignaciodelamora@yahoo.com.mx.
authors.forename: Ignacio De la Mora-De la
authors.initials: Ide L
authors.lastname: Mora
authors.affiliation: Laboratorio de Bioquímica-Genética, Instituto Nacional de Pediatría, Mexico City 04530, México. itzheltorres@hotmail.com.
authors.forename: Itzhel
authors.initials: I
authors.lastname: García-Torres
authors.affiliation: Laboratorio de Bioquímica-Genética, Instituto Nacional de Pediatría, Mexico City 04530, México. sergioenriquezflores@gmail.com.
authors.forename: Sergio
authors.initials: S
authors.lastname: Enríquez-Flores
authors.affiliation: Laboratorio de Biología Molecular, Instituto Nacional de Pediatría, Mexico City 04530, México. malcantaraortigoza@gmail.com.
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Alcántara-Ortigoza
authors.affiliation: Laboratorio de Biología Molecular, Instituto Nacional de Pediatría, Mexico City 04530, México. ariadnagonzalezdelangel@gmail.com.
authors.forename: Ariadna González-Del
authors.initials: AG
authors.lastname: Angel
authors.affiliation: Laboratorio de Biología Molecular, Instituto Nacional de Pediatría, Mexico City 04530, México. jovear2002@gmail.com.
authors.forename: José
authors.initials: J
authors.lastname: Velázquez-Aragón
authors.affiliation: Departamento de Biología Celular, Facultad de Ciencias, Universidad Nacional Autónoma de México, Mexico City 04510, México. r_oh@ciencias.unam.mx.
authors.forename: Rosario
authors.initials: R
authors.lastname: Ortiz-Hernández
authors.affiliation: Nekutli, S.A. de C.V., Zapopan, Jalisco 45070, México. jmcruz1982@gmail.com.
authors.forename: José Manuel
authors.initials: JM
authors.lastname: Cruz-Rubio
authors.affiliation: Centro Mexicano de Fomento al Desarrollo, Hidalgo 04212, México. pablovillab@yahoo.com.mx.
authors.forename: Pablo
authors.initials: P
authors.lastname: Villa-Barragán
authors.affiliation: Unidad de Investigación Traslacional & Centro de Análisis de la Evidencia, Hospital General Dr. Manuel Gea González, Mexico City 14080, México. amcrr1962@gmail.com.
authors.forename: Carlos
authors.initials: C
authors.lastname: Jiménez-Gutiérrez
authors.affiliation: Unidad de Investigación Traslacional & Centro de Análisis de la Evidencia, Hospital General Dr. Manuel Gea González, Mexico City 14080, México. inpcochrane@gmail.com.
authors.forename: Pedro
authors.initials: P
authors.lastname: Gutiérrez-Castrellón
mesh_terms: D027882:Agave / Q000737:chemistry*; D001842:Bone and Bones / Q000187:drug effects / Q000378:metabolism; D002097:C-Reactive Protein / Q000378:metabolism; D005260:Female; D005293:Ferritins / Q000097:blood; D005630:Fructans / Q000494:pharmacology*; D000069196:Gastrointestinal Microbiome / Q000187:drug effects; D006304:Health Status; D006801:Humans; D007109:Immunity / Q000187:drug effects; D041943:Infant Formula / Q000737:chemistry*; D007231:Infant, Newborn; D008297:Male; D008800:Mexico; D010865:Pilot Projects; D010936:Plant Extracts / Q000494:pharmacology*; D056692:Prebiotics; D012016:Reference Values; D016896:Treatment Outcome
chemical_list: D005630:Fructans; D010936:Plant Extracts; D056692:Prebiotics; D002097:C-Reactive Protein; D005293:Ferritins
keywords: breast milk; immune response; infant microbiota; soluble fiber