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

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

Study Overview

• Status: Completed
• Conditions: Lactation; Mothers
• Intervention / Treatment: Dietary supplement: Postibiotic formulation; Dietary supplement: Placebo formulation

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Sonora
    • Hermosillo, Sonora, Mexico, 83304
      • Centro de Investigacion En Alimentacion Y Desarrollo, A.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Daily consumption of 5 mL of edible gel with intracellular content of Lactobacillus casei CRL-431 during 30-d	Dietary supplement: Postibiotic formulation; 5 mL daily of edible gel with intracellular content of Lactobacillus casei CRL-431
Placebo Comparator: Placebo; Daily consumption of 5 mL of edible gel without intracellular content of Lactobacillus casei CRL-431 during 30-d	Dietary supplement: Placebo formulation; 5 mL daily of edible gel without intracellular content of Lactobacillus casei CRL-431

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antioxidant activity oxygen radical absorption capacity	Determination of antioxidant activity by oxygen radical absorption capacity technique in breast milk	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	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	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	Change from baseline Trolox equivalent antioxidant capacity at day 30

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superoxide dismutase enzyme activity	Determination of dismutase enzyme activity in breast milk	Change from baseline superoxide dismutase enzyme activity at day 30
Glutation peroxidase enzyme activity	Determination of glutation peroxidase enzyme activity in breast milk	Change from baseline glutton peroxidase enzyme activity at day 30
Catalase enzyme activity	Determination of catalase enzyme activity in breast milk	Change from baseline catalase enzyme activity at day 30
Glutathione activity	Determination of glutathione activity in breast milk	Change from baseline Glutathione activity at day 30
Vitamin C	Determination of Vitamin C in breast milk	Change from baseline Vitamin C at day 30
Malondialdehyde	Determination of malondialdehyde in breast milk	Change from baseline malondialdehyde at day 30
Hydrogen peroxide	Determination of hydrogen peroxide in breast milk	Change from baseline superoxide dismutase enzyme activity at day 30
Oxidative stress index	Determination of oxidative stress index in breast milk	Change from baseline oxidative stress index at day 30

Collaborators and Investigators

• Sponsor: Centro de Investigación en Alimentación y Desarrollo A.C.
• Investigators: Principal Investigator: Adrian Hernández-Mendoza, PhD, Centro de Investigacion En Alimentacion Y Desarrollo, A.C.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Lactobacillus; Nursing mothers; Breast milk; intracellular content; antioxidant capacity
• Other Study ID Numbers: AHM 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No