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

• Sponsor: Centro de Investigación en Alimentación y Desarrollo A.C. (Other)
• Overall Status: Completed
• CT.gov ID: NCT04335708
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.9
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Mothers; Lactation	Dietary Supplement: Postibiotic formulation; Dietary Supplement: Placebo formulation	Early Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of the Administration of the Intracellular Content Obtained From Lactobacillus Casei CRL-431 on the Antioxidant Capacity of Breast Milk
• Actual Study Start Date: Dec 1, 2018
• Actual Primary Completion Date: Apr 30, 2019
• Actual Study Completion Date: Apr 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. Trolox equivalent Antioxidant capacity [Change from baseline Trolox equivalent antioxidant capacity at day 15]

   Determination of Trolox equivalent antioxidant capacity in breast milk

3. Antioxidant activity oxygen radical absorption capacity [Change from baseline antioxidant activity oxygen radical absorption capacity at day 30]

   Antioxidant activity by oxygen radical absorption capacity technique in breast milk

4. Trolox equivalent antioxidant capacity [Change from baseline Trolox equivalent antioxidant capacity at day 30]

   Determination of Trolox equivalent antioxidant capacity in breast milk

Secondary Outcome Measures

1. Superoxide dismutase enzyme activity [Change from baseline superoxide dismutase enzyme activity at day 15]

   Determination of dismutase enzyme activity in breast milk

2. Glutation peroxidase enzyme activity [Change from baseline glutation peroxidase enzyme activity at day 15]

   Determination of glutation peroxidase enzyme activity in breast milk

3. Catalase enzyme activity [Change from baseline catalase enzyme activity at day 15]

   Determination of catalase enzyme activity in breast milk

4. Glutathione activity [Change from baseline glutathione activity at day 15]

   Determination of glutathione activity in breast milk

5. Vitamin C [Change from baseline Vitamin C at day 15]

   Determination of Vitamin C in breast milk

6. Malondialdehyde [Change from baseline malondialdehyde at day 15]

   Determination of malondialdehyde products by the thiobarbituric acid reactive substances test in breast milk

7. Hydrogen peroxide [Change from baseline hydrogen peroxide at day 15]

   Determination of hydrogen peroxide in breast milk

8. Oxidative stress index [Change from baseline oxidative stress index at day 15]

   Determination of oxidative stress index in breast milk

Other Outcome Measures

1. Superoxide dismutase enzyme activity [Change from baseline superoxide dismutase enzyme activity at day 30]

   Determination of dismutase enzyme activity in breast milk

2. Glutation peroxidase enzyme activity [Change from baseline glutton peroxidase enzyme activity at day 30]

   Determination of glutation peroxidase enzyme activity in breast milk

3. Catalase enzyme activity [Change from baseline catalase enzyme activity at day 30]

   Determination of catalase enzyme activity in breast milk

4. Glutathione activity [Change from baseline Glutathione activity at day 30]

   Determination of glutathione activity in breast milk

5. Vitamin C [Change from baseline Vitamin C at day 30]

   Determination of Vitamin C in breast milk

6. Malondialdehyde [Change from baseline malondialdehyde at day 30]

   Determination of malondialdehyde in breast milk

7. Hydrogen peroxide [Change from baseline superoxide dismutase enzyme activity at day 30]

   Determination of hydrogen peroxide in breast milk

8. Oxidative stress index [Change from baseline oxidative stress index at day 30]

   Determination of oxidative stress index in breast milk

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro de Investigacion En Alimentacion Y Desarrollo, A.C.	Hermosillo	Sonora	Mexico	83304

Sponsors and Collaborators

• Centro de Investigación en Alimentación y Desarrollo A.C.

Investigators

• Principal Investigator: Adrian Hernández-Mendoza, PhD, CENTRO DE INVESTIGACION EN ALIMENTACION Y DESARROLLO, A.C.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adrian Hernandez Mendoza, Principal Investigator, Centro de Investigación en Alimentación y Desarrollo A.C.
• ClinicalTrials.gov Identifier: NCT04335708
• Other Study ID Numbers: AHM 001
• First Posted: Apr 6, 2020
• Last Update Posted: Apr 6, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Adrian Hernandez Mendoza, Principal Investigator, Centro de Investigación en Alimentación y Desarrollo A.C.: Nursing mothers; Breast milk; Lactobacillus; intracellular content; antioxidant capacity

Study Results

No Results Posted as of Apr 6, 2020