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

Study Overview
=================
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.

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

Conditions
-----------------
Mothers, Lactation

Intervention / Treatment
-----------------
* Dietary Supplement: Postibiotic formulation
* Dietary Supplement: Placebo formulation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Daily consumption of 5 mL of edible gel with intracellular content of Lactobacillus casei CRL-431 during 30-d | Dietary Supplement: Postibiotic formulation<br>* 5 mL daily of edible gel with intracellular content of Lactobacillus casei CRL-431<br>|
| Placebo Comparator: Placebo<br>Daily consumption of 5 mL of edible gel without intracellular content of Lactobacillus casei CRL-431 during 30-d | Dietary Supplement: Placebo formulation<br>* 5 mL daily of edible gel without intracellular content of Lactobacillus casei CRL-431<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Trolox equivalent Antioxidant capacity | Determination of Trolox equivalent antioxidant capacity in breast milk | Change from baseline Trolox equivalent antioxidant capacity at day 15 | 
| 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 | 
| Trolox equivalent antioxidant capacity | Determination of Trolox equivalent antioxidant capacity in breast milk | Change from baseline Trolox equivalent antioxidant capacity at day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superoxide dismutase enzyme activity | Determination of dismutase enzyme activity in breast milk | Change from baseline superoxide dismutase enzyme activity at day 15 | 
| Glutation peroxidase enzyme activity | Determination of glutation peroxidase enzyme activity in breast milk | Change from baseline glutation peroxidase enzyme activity at day 15 | 
| Catalase enzyme activity | Determination of catalase enzyme activity in breast milk | Change from baseline catalase enzyme activity at day 15 | 
| Glutathione activity | Determination of glutathione activity in breast milk | Change from baseline glutathione activity at day 15 | 
| Vitamin C | Determination of Vitamin C in breast milk | Change from baseline Vitamin C at day 15 | 
| Malondialdehyde | Determination of malondialdehyde products by the thiobarbituric acid reactive substances test in breast milk | Change from baseline malondialdehyde at day 15 | 
| Hydrogen peroxide | Determination of hydrogen peroxide in breast milk | Change from baseline hydrogen peroxide at day 15 | 
| Oxidative stress index | Determination of oxidative stress index in breast milk | Change from baseline oxidative stress index at day 15 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nursing mothers, Breast milk, Lactobacillus, intracellular content, antioxidant capacity