NCT04335708

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Centro de Investigación en Alimentación y Desarrollo A.C. · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Mothers
• Lactation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Postibiotic formulation	5 mL daily of edible gel with intracellular content of Lactobacillus casei CRL-431
DIETARY_SUPPLEMENT	Placebo formulation	5 mL daily of edible gel without intracellular content of Lactobacillus casei CRL-431

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2020-04-06
• Last updated: 2023-10-05

Locations

1 site across 1 country: Mexico