Mothers, Lactation
Conditions
Keywords
Nursing mothers, Breast milk, Lactobacillus, intracellular content, antioxidant capacity
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.
Interventions
DIETARY_SUPPLEMENTPostibiotic formulation
5 mL daily of edible gel with intracellular content of Lactobacillus casei CRL-431
DIETARY_SUPPLEMENTPlacebo formulation
5 mL daily of edible gel without intracellular content of Lactobacillus casei CRL-431
Sponsors
Centro de Investigación en Alimentación y Desarrollo A.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antioxidant activity oxygen radical absorption capacity | 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 |
| Trolox equivalent Antioxidant capacity | Change from baseline Trolox equivalent antioxidant capacity at day 15 | Determination of Trolox equivalent antioxidant capacity in breast milk |
| Trolox equivalent antioxidant capacity | Change from baseline Trolox equivalent antioxidant capacity at day 30 | Determination of Trolox equivalent antioxidant capacity in breast milk |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxidative stress index | Change from baseline oxidative stress index at day 15 | Determination of oxidative stress index in breast milk |
| Superoxide dismutase enzyme activity | Change from baseline superoxide dismutase enzyme activity at day 15 | Determination of dismutase enzyme activity in breast milk |
| Glutation peroxidase enzyme activity | Change from baseline glutation peroxidase enzyme activity at day 15 | Determination of glutation peroxidase enzyme activity in breast milk |
| Catalase enzyme activity | Change from baseline catalase enzyme activity at day 15 | Determination of catalase enzyme activity in breast milk |
| Glutathione activity | Change from baseline glutathione activity at day 15 | Determination of glutathione activity in breast milk |
| Vitamin C | Change from baseline Vitamin C at day 15 | Determination of Vitamin C in breast milk |
| Malondialdehyde | Change from baseline malondialdehyde at day 15 | Determination of malondialdehyde products by the thiobarbituric acid reactive substances test in breast milk |
| Hydrogen peroxide | Change from baseline hydrogen peroxide at day 15 | Determination of hydrogen peroxide in breast milk |
Other
| Measure | Time frame | Description |
|---|---|---|
| Superoxide dismutase enzyme activity | Change from baseline superoxide dismutase enzyme activity at day 30 | Determination of dismutase enzyme activity in breast milk |
| Glutation peroxidase enzyme activity | Change from baseline glutton peroxidase enzyme activity at day 30 | Determination of glutation peroxidase enzyme activity in breast milk |
| Catalase enzyme activity | Change from baseline catalase enzyme activity at day 30 | Determination of catalase enzyme activity in breast milk |
| Glutathione activity | Change from baseline Glutathione activity at day 30 | Determination of glutathione activity in breast milk |
| Vitamin C | Change from baseline Vitamin C at day 30 | Determination of Vitamin C in breast milk |
| Malondialdehyde | Change from baseline malondialdehyde at day 30 | Determination of malondialdehyde in breast milk |
| Hydrogen peroxide | Change from baseline superoxide dismutase enzyme activity at day 30 | Determination of hydrogen peroxide in breast milk |
| Oxidative stress index | Change from baseline oxidative stress index at day 30 | Determination of oxidative stress index in breast milk |
Countries
Mexico
Outcome results
None listed