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

Centro de Investigación en Alimentación y Desarrollo A.C.18 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Mothers Lactation

Interventions

Postibiotic formulationDIETARY_SUPPLEMENT

5 mL daily of edible gel with intracellular content of Lactobacillus casei CRL-431

Placebo formulationDIETARY_SUPPLEMENT

5 mL daily of edible gel without intracellular content of Lactobacillus casei CRL-431

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Nursing mothers between 3 and 52 weeks of lactation Exclusion Criteria: * Clinical evidence of chronic disease or gastrointestinal disorders * Structural defects in the breast (breast surgery, mammary gland hypoplasia, among others) * Mastitis * Cancer and/or radiotherapy * Consumption of: antioxidant supplements, probiotics, symbiotics and/or antibiotics in the month prior to recruitment. * Alcohol or drugs consumption

Locations (1)

Centro de Investigacion En Alimentacion Y Desarrollo, A.C.

Hermosillo, Sonora, Mexico

Outcomes

Primary Outcomes

Antioxidant activity oxygen radical absorption capacity

Determination of antioxidant activity by oxygen radical absorption capacity technique in breast milk

Time frame: Change from baseline antioxidant activity oxygen radical absorption capacity at day 15

Trolox equivalent Antioxidant capacity

Determination of Trolox equivalent antioxidant capacity in breast milk

Time frame: Change from baseline Trolox equivalent antioxidant capacity at day 15

Antioxidant activity oxygen radical absorption capacity

Antioxidant activity by oxygen radical absorption capacity technique in breast milk

Time frame: Change from baseline antioxidant activity oxygen radical absorption capacity at day 30

Trolox equivalent antioxidant capacity

Determination of Trolox equivalent antioxidant capacity in breast milk

Time frame: Change from baseline Trolox equivalent antioxidant capacity at day 30

Secondary Outcomes

Superoxide dismutase enzyme activity

Determination of dismutase enzyme activity in breast milk

Time frame: Change from baseline superoxide dismutase enzyme activity at day 15

Glutation peroxidase enzyme activity

Determination of glutation peroxidase enzyme activity in breast milk

Time frame: Change from baseline glutation peroxidase enzyme activity at day 15

Catalase enzyme activity

Determination of catalase enzyme activity in breast milk

Data from ClinicalTrials.gov

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