MothersNCT04335708
Effect of Intracellular Content From Lactobacillus Casei CRL-431 on Antioxidant Capacity of Breast Milk
A study testing Postibiotic formulation in people with Mothers and Lactation, run by Centro de Investigación en Alimentación y Desarrollo A.C. at 1 site in Mexico.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- What is being tested?
- Postibiotic formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteMexico
- Study dates
- 1 Dec 2018to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nursing mothers between 3 and 52 weeks of lactation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro de Investigacion En Alimentacion Y Desarrollo, A.C.
Hermosillo, Sonora, 83304
About this study
Official title: Effect of the Administration of the Intracellular Content Obtained From Lactobacillus Casei CRL-431 on the Antioxidant Capacity of Breast Milk
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
Read the 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.
- Being tested
- Postibiotic formulation, Placebo formulation
- Keywords
- Nursing mothers, Breast milk, Lactobacillus, intracellular content, antioxidant capacity
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postibiotic formulationDietary supplement
5 mL daily of edible gel with intracellular content of Lactobacillus casei CRL-431
Placebo formulationDietary supplement
5 mL daily of edible gel without intracellular content of Lactobacillus casei CRL-431
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Daily consumption of 5 mL of edible gel with intracellular content of Lactobacillus casei CRL-431 during 30-d Receives: 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 Receives: Dietary Supplement: Placebo formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antioxidant activity oxygen radical absorption capacity
Determination of antioxidant activity by oxygen radical absorption capacity technique in breast milk
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline Trolox equivalent antioxidant capacity at day 30
Secondary outcomes (8)
Superoxide dismutase enzyme activity
Determination of dismutase enzyme activity in breast milk
Measured: Change from baseline superoxide dismutase enzyme activity at day 15
Glutation peroxidase enzyme activity
Determination of glutation peroxidase enzyme activity in breast milk
Measured: Change from baseline glutation peroxidase enzyme activity at day 15
Catalase enzyme activity
Determination of catalase enzyme activity in breast milk
Measured: Change from baseline catalase enzyme activity at day 15
Glutathione activity
Determination of glutathione activity in breast milk
Measured: Change from baseline glutathione activity at day 15
Vitamin C
Determination of Vitamin C in breast milk
Measured: Change from baseline Vitamin C at day 15
Malondialdehyde
Determination of malondialdehyde products by the thiobarbituric acid reactive substances test in breast milk
Measured: Change from baseline malondialdehyde at day 15
Hydrogen peroxide
Determination of hydrogen peroxide in breast milk
Measured: Change from baseline hydrogen peroxide at day 15
Oxidative stress index
Determination of oxidative stress index in breast milk
Measured: Change from baseline oxidative stress index at day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start1 Dec 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MothersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian Hernandez Mendoza, Centro de Investigación en Alimentación y Desarrollo A.C.
- Investigators
- Adrian Hernández-Mendoza, PhD, Principal investigator, CENTRO DE INVESTIGACION EN ALIMENTACION Y DESARROLLO, A.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335708
- Sponsor's protocol ID
- AHM 001
- Status last verified
- Oct 2023
- First submitted
- 17 Mar 2020
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Administration of the Intracellular Content Obtained From Lactobacillus Casei CRL-431 on the Antioxidant Capacity of Breast Milk
- ClinicalTrials.gov ID
- NCT04335708
- Acronym / sponsor ID
- AHM 001
- Keywords
- Nursing mothers, Breast milk, Lactobacillus, intracellular content, antioxidant capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.University, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Postibiotic formulationDaily consumption of 5 mL of edible gel with intracellular content of Lactobacillus casei CRL-431 during 30-d |
| Placebo | Placebo comparator | Dietary Supplement: Placebo formulationDaily consumption of 5 mL of edible gel without intracellular content of Lactobacillus casei CRL-431 during 30-d |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Nursing mothers between 3 and 52 weeks of lactation
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postibiotic formulation5 mL daily of edible gel with intracellular content of Lactobacillus casei CRL-431 | Dietary supplement | Intervention |
| Placebo formulation5 mL daily of edible gel without intracellular content of Lactobacillus casei CRL-431 | Dietary supplement | Placebo |
Primary outcome
Antioxidant activity oxygen radical absorption capacity
Time frame: 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
Time frame: Change from baseline Trolox equivalent antioxidant capacity at day 15
Determination of Trolox equivalent antioxidant capacity in breast milk
Antioxidant activity oxygen radical absorption capacity
Time frame: Change from baseline antioxidant activity oxygen radical absorption capacity at day 30
Antioxidant activity by oxygen radical absorption capacity technique in breast milk
Trolox equivalent antioxidant capacity
Time frame: Change from baseline Trolox equivalent antioxidant capacity at day 30
Determination of Trolox equivalent antioxidant capacity in breast milk
8 secondary outcomes
Superoxide dismutase enzyme activity
Time frame: Change from baseline superoxide dismutase enzyme activity at day 15
Glutation peroxidase enzyme activity
Time frame: Change from baseline glutation peroxidase enzyme activity at day 15
Catalase enzyme activity
Time frame: Change from baseline catalase enzyme activity at day 15
Glutathione activity
Time frame: Change from baseline glutathione activity at day 15
Vitamin C
Time frame: Change from baseline Vitamin C at day 15
Malondialdehyde
Time frame: Change from baseline malondialdehyde at day 15
Hydrogen peroxide
Time frame: Change from baseline hydrogen peroxide at day 15
Oxidative stress index
Time frame: Change from baseline oxidative stress index at day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Hernández-Mendoza, PhD principal investigator
CENTRO DE INVESTIGACION EN ALIMENTACION Y DESARROLLO, A.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postibiotic formulation in people with Mothers and Lactation, run by Centro de Investigación en Alimentación y Desarrollo A.C. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antioxidant activity oxygen radical absorption capacity (time frame: Change from baseline antioxidant activity oxygen radical absorption capacity at day 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.