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

Lactation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04335708
• Other study ID #: AHM 001
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: October 2023
• Source: Centro de Investigación en Alimentación y Desarrollo A.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Lactation
• Mothers

Intervention

Dietary Supplement:
• Postibiotic formulation
5 mL daily of edible gel with intracellular content of Lactobacillus casei CRL-431
• Placebo formulation
5 mL daily of edible gel without intracellular content of Lactobacillus casei CRL-431

Locations

Country	Name	City	State
Mexico	Centro de Investigacion En Alimentacion Y Desarrollo, A.C.	Hermosillo	Sonora

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Investigación en Alimentación y Desarrollo A.C.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Superoxide dismutase enzyme activity	Determination of dismutase enzyme activity in breast milk	Change from baseline superoxide dismutase enzyme activity at day 30
Other	Glutation peroxidase enzyme activity	Determination of glutation peroxidase enzyme activity in breast milk	Change from baseline glutton peroxidase enzyme activity at day 30
Other	Catalase enzyme activity	Determination of catalase enzyme activity in breast milk	Change from baseline catalase enzyme activity at day 30
Other	Glutathione activity	Determination of glutathione activity in breast milk	Change from baseline Glutathione activity at day 30
Other	Vitamin C	Determination of Vitamin C in breast milk	Change from baseline Vitamin C at day 30
Other	Malondialdehyde	Determination of malondialdehyde in breast milk	Change from baseline malondialdehyde at day 30
Other	Hydrogen peroxide	Determination of hydrogen peroxide in breast milk	Change from baseline superoxide dismutase enzyme activity at day 30
Other	Oxidative stress index	Determination of oxidative stress index in breast milk	Change from baseline oxidative stress index at day 30
Primary	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
Primary	Trolox equivalent Antioxidant capacity	Determination of Trolox equivalent antioxidant capacity in breast milk	Change from baseline Trolox equivalent antioxidant capacity at day 15
Primary	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
Primary	Trolox equivalent antioxidant capacity	Determination of Trolox equivalent antioxidant capacity in breast milk	Change from baseline Trolox equivalent antioxidant capacity at day 30
Secondary	Superoxide dismutase enzyme activity	Determination of dismutase enzyme activity in breast milk	Change from baseline superoxide dismutase enzyme activity at day 15
Secondary	Glutation peroxidase enzyme activity	Determination of glutation peroxidase enzyme activity in breast milk	Change from baseline glutation peroxidase enzyme activity at day 15
Secondary	Catalase enzyme activity	Determination of catalase enzyme activity in breast milk	Change from baseline catalase enzyme activity at day 15
Secondary	Glutathione activity	Determination of glutathione activity in breast milk	Change from baseline glutathione activity at day 15
Secondary	Vitamin C	Determination of Vitamin C in breast milk	Change from baseline Vitamin C at day 15
Secondary	Malondialdehyde	Determination of malondialdehyde products by the thiobarbituric acid reactive substances test in breast milk	Change from baseline malondialdehyde at day 15
Secondary	Hydrogen peroxide	Determination of hydrogen peroxide in breast milk	Change from baseline hydrogen peroxide at day 15
Secondary	Oxidative stress index	Determination of oxidative stress index in breast milk	Change from baseline oxidative stress index at day 15