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

Centro de Investigación en Alimentación y Desarrollo A.C.

Status: Completed

Conditions: Lactation; Mothers

Treatments: Dietary Supplement: Placebo formulation; Dietary Supplement: Postibiotic formulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04335708

AHM 001

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Daily consumption of 5 mL of edible gel with intracellular content of Lactobacillus casei CRL-431 during 30-d

Treatment:

Dietary Supplement: Postibiotic formulation

Placebo

Placebo Comparator group

Description:

Daily consumption of 5 mL of edible gel without intracellular content of Lactobacillus casei CRL-431 during 30-d

Treatment:

Dietary Supplement: Placebo formulation