Clinical trial NCT04335708: Effect of Intracellular Content From Lactobacillus Casei CRL-431 on Antioxidant Capacity of Breast Milk
Official title: Effect of the Administration of the Intracellular Content Obtained From Lactobacillus Casei CRL-431 on the Antioxidant Capacity of Breast Milk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mothers
Lactation
Keywords: Nursing mothers
Breast milk
Lactobacillus
intracellular content
antioxidant capacity
Lead sponsor: Centro de Investigación en Alimentación y Desarrollo A.C.
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Antioxidant activity oxygen radical absorption capacity
timeFrame: Change from baseline antioxidant activity oxygen radical absorption capacity at day 15
measure: Trolox equivalent Antioxidant capacity
timeFrame: Change from baseline Trolox equivalent antioxidant capacity at day 15
measure: Antioxidant activity oxygen radical absorption capacity
timeFrame: Change from baseline antioxidant activity oxygen radical absorption capacity at day 30
measure: Trolox equivalent antioxidant capacity
timeFrame: Change from baseline Trolox equivalent antioxidant capacity at day 30
Secondary outcomes:
measure: Superoxide dismutase enzyme activity
timeFrame: Change from baseline superoxide dismutase enzyme activity at day 15
measure: Glutation peroxidase enzyme activity
timeFrame: Change from baseline glutation peroxidase enzyme activity at day 15
measure: Catalase enzyme activity
timeFrame: Change from baseline catalase enzyme activity at day 15
measure: Glutathione activity
timeFrame: Change from baseline glutathione activity at day 15
measure: Vitamin C
timeFrame: Change from baseline Vitamin C at day 15
measure: Malondialdehyde
timeFrame: Change from baseline malondialdehyde at day 15
measure: Hydrogen peroxide
timeFrame: Change from baseline hydrogen peroxide at day 15
measure: Oxidative stress index
timeFrame: Change from baseline oxidative stress index at day 15
Other outcomes:
measure: Superoxide dismutase enzyme activity
timeFrame: Change from baseline superoxide dismutase enzyme activity at day 30
measure: Glutation peroxidase enzyme activity
timeFrame: Change from baseline glutton peroxidase enzyme activity at day 30
measure: Catalase enzyme activity
timeFrame: Change from baseline catalase enzyme activity at day 30
measure: Glutathione activity
timeFrame: Change from baseline Glutathione activity at day 30
measure: Vitamin C
timeFrame: Change from baseline Vitamin C at day 30
measure: Malondialdehyde
timeFrame: Change from baseline malondialdehyde at day 30
measure: Hydrogen peroxide
timeFrame: Change from baseline superoxide dismutase enzyme activity at day 30
measure: Oxidative stress index
timeFrame: Change from baseline oxidative stress index at day 30
Locations:
city: Hermosillo
country: Mexico
facility: Centro de Investigacion En Alimentacion Y Desarrollo, A.C.
state: Sonora
Study officials:
affiliation: CENTRO DE INVESTIGACION EN ALIMENTACION Y DESARROLLO, A.C.
name: Adrian Hernández-Mendoza, PhD
role: PRINCIPAL_INVESTIGATOR
References: