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

Not Applicable

Completed

• Conditions: Mothers; Lactation
• Interventions: Dietary Supplement: Placebo formulation; Dietary Supplement: Postibiotic formulation

• Registration Number: NCT04335708
• Lead Sponsor: Centro de Investigación en Alimentación y Desarrollo A.C.

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 (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 Timeline

• Study Start: 2018-12-01
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-06
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo formulation	Daily consumption of 5 mL of edible gel without intracellular content of Lactobacillus casei CRL-431 during 30-d
Intervention	Postibiotic formulation	Daily consumption of 5 mL of edible gel with intracellular content of Lactobacillus casei CRL-431 during 30-d

Primary Outcome Measures

Name	Time	Method
Antioxidant activity oxygen radical absorption capacity	Change from baseline antioxidant activity oxygen radical absorption capacity at day 30	Antioxidant activity by oxygen radical absorption capacity technique in breast milk
Trolox equivalent antioxidant capacity	Change from baseline Trolox equivalent antioxidant capacity at day 30	Determination of Trolox equivalent antioxidant capacity in breast milk
Trolox equivalent Antioxidant capacity	Change from baseline Trolox equivalent antioxidant capacity at day 15	Determination of Trolox equivalent antioxidant capacity in breast milk

Secondary Outcome Measures

Name	Time	Method
Superoxide dismutase enzyme activity	Change from baseline superoxide dismutase enzyme activity at day 15	Determination of dismutase enzyme activity in breast milk
Glutation peroxidase enzyme activity	Change from baseline glutation peroxidase enzyme activity at day 15	Determination of glutation peroxidase enzyme activity in breast milk
Vitamin C	Change from baseline Vitamin C at day 15	Determination of Vitamin C in breast milk
Catalase enzyme activity	Change from baseline catalase enzyme activity at day 15	Determination of catalase enzyme activity in breast milk
Glutathione activity	Change from baseline glutathione activity at day 15	Determination of glutathione activity in breast milk
Malondialdehyde	Change from baseline malondialdehyde at day 15	Determination of malondialdehyde products by the thiobarbituric acid reactive substances test in breast milk
Hydrogen peroxide	Change from baseline hydrogen peroxide at day 15	Determination of hydrogen peroxide in breast milk
Oxidative stress index	Change from baseline oxidative stress index at day 15	Determination of oxidative stress index in breast milk

Trial Locations

Locations (1)

Centro de Investigacion En Alimentacion Y Desarrollo, A.C.; 🇲🇽 Hermosillo, Sonora, Mexico