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

NCT04335708 | Completed

• 1 other identifier: AHM 001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Mothers; Lactation

Keywords

Nursing mothers; Breast milk; Lactobacillus; intracellular content; antioxidant capacity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Superoxide dismutase enzyme activity

  Change from baseline superoxide dismutase enzyme activity at day 15

• Glutation peroxidase enzyme activity

  Change from baseline glutation peroxidase enzyme activity at day 15

• Catalase enzyme activity

  Change from baseline catalase enzyme activity at day 15

• Glutathione activity

  Change from baseline glutathione activity at day 15

• Vitamin C

  Change from baseline Vitamin C at day 15

Other Outcomes (8)

• Superoxide dismutase enzyme activity

  Change from baseline superoxide dismutase enzyme activity at day 30

• Glutation peroxidase enzyme activity

  Change from baseline glutton peroxidase enzyme activity at day 30

• Catalase enzyme activity

  Change from baseline catalase enzyme activity at day 30

Study Arms (2)

Intervention

EXPERIMENTAL

Daily consumption of 5 mL of edible gel with intracellular content of Lactobacillus casei CRL-431 during 30-d

Dietary Supplement: Postibiotic formulation

Placebo

PLACEBO COMPARATOR

Daily consumption of 5 mL of edible gel without intracellular content of Lactobacillus casei CRL-431 during 30-d

Dietary Supplement: Placebo formulation

Interventions

Postibiotic formulation DIETARY_SUPPLEMENT

5 mL daily of edible gel with intracellular content of Lactobacillus casei CRL-431

Intervention

Placebo formulation DIETARY_SUPPLEMENT

5 mL daily of edible gel without intracellular content of Lactobacillus casei CRL-431

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Nursing mothers between 3 and 52 weeks of lactation

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Centro de Investigacion En Alimentacion Y Desarrollo, A.C.

Hermosillo, Sonora, 83304, Mexico

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Adrian Hernández-Mendoza, PhD

  CENTRO DE INVESTIGACION EN ALIMENTACION Y DESARROLLO, A.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: April 6, 2020
• Study Start: December 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)