Ignite Creation Date:
2024-05-06 @ 2:29 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04335708
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2020-03-17
Brief Title:
Effect of Intracellular Content From Lactobacillus Casei CRL-431 on Antioxidant Capacity of Breast Milk
Sponsor:
Centro de Investigación en Alimentación y Desarrollo AC
Organization:
Centro de Investigación en Alimentación y Desarrollo AC
Study Overview
Official Title:
Effect of the Administration of the Intracellular Content Obtained From Lactobacillus Casei CRL-431 on the Antioxidant Capacity of Breast Milk
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 n8 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 005 or less two sided when there was a statistical differences Non-parametric data were analyzed with Mann-Whitney test using statistical software
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None