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Completed

NCT Number: NCT04335708

Effect of Intracellular Content From Lactobacillus Casei CRL-431 on 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

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Key information

Conditions

Mothers Behavior Breast Feeding Feeding Behavior Lactation

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Hermosillo, Sonora, 83304, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postibiotic formulation

Dietary Supplement

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

Placebo formulation

Dietary Supplement

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Superoxide dismutase enzyme activity

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

    Determination of dismutase enzyme activity in breast milk

  2. 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

  3. Catalase enzyme activity

    Time frame: Change from baseline catalase enzyme activity at day 15

    Determination of catalase enzyme activity in breast milk

  4. Glutathione activity

    Time frame: Change from baseline glutathione activity at day 15

    Determination of glutathione activity in breast milk

  5. Vitamin C

    Time frame: Change from baseline Vitamin C at day 15

    Determination of Vitamin C in breast milk

  6. Malondialdehyde

    Time frame: Change from baseline malondialdehyde at day 15

    Determination of malondialdehyde products by the thiobarbituric acid reactive substances test in breast milk

  7. Hydrogen peroxide

    Time frame: Change from baseline hydrogen peroxide at day 15

    Determination of hydrogen peroxide in breast milk

  8. Oxidative stress index

    Time frame: Change from baseline oxidative stress index at day 15

    Determination of oxidative stress index in breast milk

Other outcomes

  1. Superoxide dismutase enzyme activity

    Time frame: Change from baseline superoxide dismutase enzyme activity at day 30

    Determination of dismutase enzyme activity in breast milk

  2. 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

  3. Catalase enzyme activity

    Time frame: Change from baseline catalase enzyme activity at day 30

    Determination of catalase enzyme activity in breast milk

  4. Glutathione activity

    Time frame: Change from baseline Glutathione activity at day 30

    Determination of glutathione activity in breast milk

  5. Vitamin C

    Time frame: Change from baseline Vitamin C at day 30

    Determination of Vitamin C in breast milk

  6. Malondialdehyde

    Time frame: Change from baseline malondialdehyde at day 30

    Determination of malondialdehyde in breast milk

  7. Hydrogen peroxide

    Time frame: Change from baseline superoxide dismutase enzyme activity at day 30

    Determination of hydrogen peroxide in breast milk

  8. Oxidative stress index

    Time frame: Change from baseline oxidative stress index at day 30

    Determination of oxidative stress index in breast milk

Sponsors and collaborators

Lead sponsor

Centro de Investigación en Alimentación y Desarrollo A.C.

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 6, 2020
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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