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Effect of Intracellular Content From Lactobacillus Casei CRL-431 on Antioxidant Capacity of Breast Milk

Lactation Clinical Trial

Official title:
Effect of the Administration of the Intracellular Content Obtained From Lactobacillus Casei CRL-431 on the Antioxidant Capacity of Breast Milk

Clinical Trial Summary

The objective of the present study was to evaluate the effect of the consumption of the intracellular content of Lactobacillus casei CRL-431 on the antioxidant capacity of breast milk

Clinical Trial Description

A double blind randomized controlled clinical study of an 30-d intervention with 16 nursing mothers was carried out to evaluate the effect of the consumption of the intracellular content of Lactobacillus casei CRL-431 on the antioxidant capacity of breast milk. Once obtained the informed consent; volunteers were ramdomized into two groups (n=8) to either receive 5 mL daily: edible gel with intracellular content of Lb. casei CRL-431 (intervention group) or edible gel without intracellular content of Lb. casei CRL-431 as control (placebo). Both gels were consumed daily. Participants were asked not to change their diet or lifestyle during the intervention. We applied intention to treat for those participants who did not have good adherence and those who withdraw the study. The outcomes between groups were analyzed using a independent samples student t-test, with P value of 0.05 or less (two sided) when there was a statistical differences. Non-parametric data were analyzed with Mann-Whitney test; using statistical software. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04335708
Study type Interventional
Source Centro de Investigación en Alimentación y Desarrollo A.C.
Contact
Status Completed
Phase N/A
Start date December 1, 2018
Completion date April 30, 2019
View Details
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