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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04335708
Other study ID # AHM 001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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