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

October 3, 2023 updated by: Adrian Hernandez Mendoza, Centro de Investigación en Alimentación y Desarrollo A.C.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Antioxidant activity oxygen radical absorption capacity
Time Frame: Change from baseline antioxidant activity oxygen radical absorption capacity at day 15
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
Time Frame: Change from baseline Trolox equivalent antioxidant capacity at day 15
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
Time Frame: Change from baseline antioxidant activity oxygen radical absorption capacity at day 30
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
Time Frame: Change from baseline Trolox equivalent antioxidant capacity at day 30
Determination of Trolox equivalent antioxidant capacity in breast milk
Change from baseline Trolox equivalent antioxidant capacity at day 30

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Superoxide dismutase enzyme activity
Time Frame: Change from baseline superoxide dismutase enzyme activity at day 15
Determination of dismutase enzyme activity in breast milk
Change from baseline superoxide dismutase enzyme activity at day 15
Glutation peroxidase enzyme activity
Time Frame: Change from baseline glutation peroxidase enzyme activity at day 15
Determination of glutation peroxidase enzyme activity in breast milk
Change from baseline glutation peroxidase enzyme activity at day 15
Catalase enzyme activity
Time Frame: Change from baseline catalase enzyme activity at day 15
Determination of catalase enzyme activity in breast milk
Change from baseline catalase enzyme activity at day 15
Glutathione activity
Time Frame: Change from baseline glutathione activity at day 15
Determination of glutathione activity in breast milk
Change from baseline glutathione activity at day 15
Vitamin C
Time Frame: Change from baseline Vitamin C at day 15
Determination of Vitamin C in breast milk
Change from baseline Vitamin C at day 15
Malondialdehyde
Time Frame: Change from baseline malondialdehyde at day 15
Determination of malondialdehyde products by the thiobarbituric acid reactive substances test in breast milk
Change from baseline malondialdehyde at day 15
Hydrogen peroxide
Time Frame: Change from baseline hydrogen peroxide at day 15
Determination of hydrogen peroxide in breast milk
Change from baseline hydrogen peroxide at day 15
Oxidative stress index
Time Frame: Change from baseline oxidative stress index at day 15
Determination of oxidative stress index in breast milk
Change from baseline oxidative stress index at day 15

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Superoxide dismutase enzyme activity
Time Frame: Change from baseline superoxide dismutase enzyme activity at day 30
Determination of dismutase enzyme activity in breast milk
Change from baseline superoxide dismutase enzyme activity at day 30
Glutation peroxidase enzyme activity
Time Frame: Change from baseline glutton peroxidase enzyme activity at day 30
Determination of glutation peroxidase enzyme activity in breast milk
Change from baseline glutton peroxidase enzyme activity at day 30
Catalase enzyme activity
Time Frame: Change from baseline catalase enzyme activity at day 30
Determination of catalase enzyme activity in breast milk
Change from baseline catalase enzyme activity at day 30
Glutathione activity
Time Frame: Change from baseline Glutathione activity at day 30
Determination of glutathione activity in breast milk
Change from baseline Glutathione activity at day 30
Vitamin C
Time Frame: Change from baseline Vitamin C at day 30
Determination of Vitamin C in breast milk
Change from baseline Vitamin C at day 30
Malondialdehyde
Time Frame: Change from baseline malondialdehyde at day 30
Determination of malondialdehyde in breast milk
Change from baseline malondialdehyde at day 30
Hydrogen peroxide
Time Frame: Change from baseline superoxide dismutase enzyme activity at day 30
Determination of hydrogen peroxide in breast milk
Change from baseline superoxide dismutase enzyme activity at day 30
Oxidative stress index
Time Frame: Change from baseline oxidative stress index at day 30
Determination of oxidative stress index in breast milk
Change from baseline oxidative stress index at day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centro de Investigación en Alimentación y Desarrollo A.C.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adrian Hernández-Mendoza, PhD, Centro de Investigacion En Alimentacion Y Desarrollo, A.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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