A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Healthy Term Babies	Dietary Supplement: Infant Formula; Dietary Supplement: Exclusively breast milk; Dietary Supplement: Metlin+metlos+Lactobacillus GG; Dietary Supplement: Metlin + Lactobacillus GG; Dietary Supplement: Metlos + lactobacillus GG; Dietary Supplement: Lactobacillus GG	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	600 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
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 Start Date :	February 2010
Actual Primary Completion Date :	May 2010
Actual Study Completion Date :	October 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Infant Formula; Infant Formula without lactobaillus or Metlin or Metlos	Dietary Supplement: Infant Formula; Only Infant Formula without Lactobacillus, Metlin OR Metlos
Active Comparator: Fully breast milk; Group non randomized with fully breast milk	Dietary Supplement: Exclusively breast milk; Children non randomized which mothers decided to feed them with exclusively breast milk
Experimental: Metlin+Metlos+Lactobacillus GG; Infant Formula added with Metlin+Metlos (6g/L) and Lactobacillus GG 0.3x107UFC	Dietary Supplement: Metlin+metlos+Lactobacillus GG; A prebiotic Agave Derivated Metlin+Metlos (6g/L) + 0.3x107 UFC Lactobacillus GG
Active Comparator: Metlin+Lactobacillus GG; Infant Formula added with Metlin (6g/L) + Lactobacillus GG 0.3x107 UFC	Dietary Supplement: Metlin + Lactobacillus GG; A prebiotic Agave Derivated Metlin (6g/L) + 0.3x107 UFC Lactobacillus GG
Active Comparator: Metlos+Lactobacillus GG; Infant Formula added with Metlos (6g/L)+Lactobacillus GG 0.3x107UFC	Dietary Supplement: Metlos + lactobacillus GG; A prebiotic Agave Derivated Metlos (6g/L) + 0.3x107 UFC Lactobacillus GG
Active Comparator: Lactobacillus GG; Infant Formula added with Lactobacillus GG 0.3x107UFC without Metlin or Metlos	Dietary Supplement: Lactobacillus GG; An Infant Formula added with 0.3x107 UFC Lactobacillus GG with no Metlin or Metlos

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Safety of Metlin & Metlos Aministration in Infant Formula [ Time Frame: February 2010 to September 2010 ]
   Safety of Metlin & Metlos administration in infant formula was measured by means of the frequency of stools output reported daily by the mother or the keeper (nurse) during the whole study and by the presence gastrointestinal manifestations of intolerance (abdominal distension, flatulency, regurgitations, vomiting), or by the report of eczema type dermatological problems.

Secondary Outcome Measures :

1. Efficacy of Administration of Metlin & Metlos in Infant Formula [ Time Frame: February 2010 to September 2010 ]
   Efficacy of Metlin & Metlos in Infant Formula was measured by means of the change on the intestinal micro flora; changes in the lipids profile (cholesterol, triglycerides, lipoproteins associated to cholesterol); changes in the anthropomorphic profile and somatic growth ( weight gain, stature, arm mean circumference, skin folds); bone mineral metabolism (bone ultrasonography); changes in the immunity (changes in the concentrations of salivary IgA) and reduction of respiratory events suggestive of infection.

Eligibility Criteria

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Ages Eligible for Study:	up to 30 Days (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Mexico
National Pediatric Institute
Mexico city, Mexico, 04530

Sponsors and Collaborators

National Institute of Pediatrics, Mexico

Nekutli S.A. de C.V.

Investigators

Study Director:	Gabriel Lopez-Vealzquez, PhD	National Insitute of Pediatrics, Mexico
Principal Investigator:	Pedro Gutierrez-Castrellon, MD, MSc, DSc	National Institute of Pediatrics, Mexico

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Sabater-Molina M, Larqué 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. Review.

Other Publications:

Leach JD, Sobolik KD. High dietary intake of prebiotic inulin-type fructans in the prehistoric Chihuahuan Desert. Br J Nutr. 2010 Jun;103(11):1558-61. doi: 10.1017/S0007114510000966. Epub 2010 Apr 26.

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.

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.

Grüber 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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

López-Velázquez G, Parra-Ortiz M, Mora Ide L, García-Torres I, Enríquez-Flores S, Alcántara-Ortigoza MA, Angel AG, Velázquez-Aragón J, Ortiz-Hernández R, Cruz-Rubio JM, Villa-Barragán P, Jiménez-Gutiérrez C, Gutiérrez-Castrellón 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.

Responsible Party:	Pedro Gutierrez Castrellon, National Pediatric of Pediatrics, Mexico
ClinicalTrials.gov Identifier:	NCT01251783 History of Changes
Other Study ID Numbers:	Metlin&MetlosChildren
First Posted:	December 2, 2010
Last Update Posted:	December 2, 2010
Last Verified:	December 2010

Keywords provided by National Institute of Pediatrics, Mexico:

term babies