Clinical trial NCT01251783: A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula
Official title: Double Blind, Randomized, Controlled Clinical Trial for Evaluate The Efficiency and Safety of a Fiber System From Agave, With Prebiotic Action, Metlin® and Metlos®, Incorporated to an Infant Formula for Term Newborn Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Term Babies
Keywords: term babies
Lead sponsor: National Institute of Pediatrics, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Nekutli S.A. de C.V.
First posted: 2010-12-02
Enrollment: 600
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objectives: To evaluate the safety; efficacy; bone mineral metabolism \& immunity changes of the use of Metlin \& Metlos added to the Infant Formula Study Design: Randomized, double blind, clinical, controlled trial, in 600 full-term infants of 15 ± 7 days randomized to recive formula with probiotics + Metlin + Metlos; formula with probiotics + Metlin; Formula with probiotics + Metlos; formula only with probiotics or formula without probiotics and prebiotics; having a totally breast feed group as control.). Outcomes variables were frequency of stools; bowel intolerance manifestations (abdominal distension, flatulency, regurgitations, vomiting); report of dermatological problems like eczema; changes on the intestinal microbiota; lipids profile (cholesterol, triglycerides, lipoproteins associated to cholesterol); anthropomorphic profile and somatic growth ( weight gain, stature, arm mean circumference, skin folds); bone mineral metabolism (high-speed bone ultrasonography); and changes in the immunity (changes in the concentrations of salivary IgA and the frequency of respiratory events suggestive of infection)\]. Statistical analysis was made with STATA Ver. 11.0 for Mac. Safety and efficacy variables, were compared by Chi squared in the case of categorical variables or by ANOVA or Kruskall Wallis for the numeric variables. When convenient, a covariates adjustment was done by ANOVA or by multiple lineal regressions for continuous numerical outcomes or logistic regression for categoric outcomes. In all the hypothesis tests the p significant value of \<0.05 were used.


Eligibility criteria: Inclusion Criteria:

* Healthy term babies (37 to 42 weeks of gestationl age)
* Age 15 ± 7 days at admission
* Birth weight \> 2,490 g.
* Negative history of formula intolerance (only randomized babies)
* Signed Informed Consent

Exclusion Criteria:

* Clinical evidence of chronic cardiac, respiratory, gastrointestinal, hematological or metabolic disease.
* Maternal medical history of diabetes (gestational diabetes was acceptable if the infant's birth weight was at or below the percentile 95; or 4153 g or 9 lbs 3 oz for girls or 4340 g or 9 lbs 9 oz for boys
* Tuberculosis, immunologic deficiency, infection disease or perinatal infections known to cause adverse effects in the fetus
* Participation in other study
* Inability of the father/mother or legal tutor to reed or comprehend the informed consent and the symtoms report diary, or
* The infant was part of multiple labor (twins, triplets, etc.)

Primary outcomes:
measure: Safety of Metlin & Metlos Aministration in Infant Formula
timeFrame: February 2010 to September 2010
Secondary outcomes:
measure: Efficacy of Administration of Metlin & Metlos in Infant Formula
timeFrame: February 2010 to September 2010
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: National Pediatric Institute
Study officials:
affiliation: National Insitute of Pediatrics, Mexico
name: Gabriel Lopez-Vealzquez, PhD
role: STUDY_DIRECTOR
affiliation: National Institute of Pediatrics, Mexico
name: Pedro Gutierrez-Castrellon, MD, MSc, DSc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Gomez E, Tuohy KM, Gibson GR, Klinder A, Costabile A. In vitro evaluation of the fermentation properties and potential prebiotic activity of Agave fructans. J Appl Microbiol. 2010 Jun;108(6):2114-21. doi: 10.1111/j.1365-2672.2009.04617.x. Epub 2009 Nov 4.
citation: Lopez MG, Mancilla-Margalli NA, Mendoza-Diaz G. Molecular structures of fructans from Agave tequilana Weber var. azul. J Agric Food Chem. 2003 Dec 31;51(27):7835-40. doi: 10.1021/jf030383v.
citation: Gruber C, van Stuijvenberg M, Mosca F, Moro G, Chirico G, Braegger CP, Riedler J, Boehm G, Wahn U; MIPS 1 Working Group. Reduced occurrence of early atopic dermatitis because of immunoactive prebiotics among low-atopy-risk infants. J Allergy Clin Immunol. 2010 Oct;126(4):791-7. doi: 10.1016/j.jaci.2010.07.022. Epub 2010 Sep 15.
citation: Sazawal S, Dhingra U, Hiremath G, Sarkar A, Dhingra P, Dutta A, Verma P, Menon VP, Black RE. Prebiotic and probiotic fortified milk in prevention of morbidities among children: community-based, randomized, double-blind, controlled trial. PLoS One. 2010 Aug 13;5(8):e12164. doi: 10.1371/journal.pone.0012164.
citation: Sabater-Molina M, Larque E, Torrella F, Zamora S. Dietary fructooligosaccharides and potential benefits on health. J Physiol Biochem. 2009 Sep;65(3):315-28. doi: 10.1007/BF03180584.
citation: Lopez-Velazquez G, Parra-Ortiz M, Mora Ide L, Garcia-Torres I, Enriquez-Flores S, Alcantara-Ortigoza MA, Angel AG, Velazquez-Aragon J, Ortiz-Hernandez R, Cruz-Rubio JM, Villa-Barragan P, Jimenez-Gutierrez C, Gutierrez-Castrellon P. Effects of Fructans from Mexican Agave in Newborns Fed with Infant Formula: A Randomized Controlled Trial. Nutrients. 2015 Oct 29;7(11):8939-51. doi: 10.3390/nu7115442.