Oxidative StressBIONCT03798821
The Antioxidant Efficacy of a Product Probiotic in Research
A study testing Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG) and Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG) in people with Oxidative Stress, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Determine the efficacy of the investigational product versus placebo in reducing stress oxidative during the performance of a physical exercise of a certain intensity and duration. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG) and Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2018to 4 Jan 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: between 18 and 45 years
- Sex: male, of Caucasian race, selected from the general population.
- Subjects that perform aerobic physical exercise between 2 and 4 times a week.
- Volunteers capable of understanding the clinical study, willing to grant consent informed in writing and to comply with the procedures and requirements of the study
Who cannot join
- Subjects with a history of any chronic disease.
- History of bronchial asthma or chronic obstructive pulmonary disease, disease Reactive airways such as bronchial asthma, a history of bronchial asthma or severe chronic obstructive pulmonary disease.
- Sinus bradycardia, second or third degree of atrioventricular block, insufficiency manifest cardiac or cardiogenic shock.
- History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- Participation in another clinical trial in the three months prior to the study Lack of will or inability to comply with clinical trial procedures.
- Subjects diagnosed and / or under treatment for arterial hypertension.
Show all 10Show fewer
- Smoking subjects (> 10 cigarettes a day).
- Subjects with body mass index greater than 35 Kg / m2 (BMI> 30).
- Subjects with a history of drug, alcohol or other substance abuse or other factors that limit their ability to cooperate during the study.
- Subjects whose condition does not make them eligible for the study according to the researcher's criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Clinical Trial to Evaluate the Antioxidant Efficacy of a Product Probiotic in Research
Determine the efficacy of the investigational product versus placebo in reducing stress oxidative during the performance of a physical exercise of a certain intensity and duration.
Read the detailed description
The effectiveness of a probiotic for oxidative stress after eight weeks of the product to study will be checked. the sample will be formed by cyclists that will submit to a baseline exercise and after the product is taken.
- Conditions
- Oxidative Stress
- Being tested
- Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG), Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG), maltodextrin and sucrose (PLACEBO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG)Dietary supplement
six weeks of consumption
Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG)Dietary supplement
six weeks of consumption
maltodextrin and sucrose (PLACEBO)Dietary supplement
six weeks of consumption
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | One capsule a day will be consumed. At breakfast for the six weeks. Receives: Dietary Supplement: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG); Dietary Supplement: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG) |
| Comparator | Placebo comparator | One capsule a day will be consumed. At breakfast for the six weeks. Receives: Dietary Supplement: maltodextrin and sucrose (PLACEBO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative damage to lipids
It will be measured by isoprostanes in urine 24 hours.
Measured: Oxidative lipid damage will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Secondary outcomes (8)
Oxidative damage to DNA
Analysis of 8-oxo 2'-deoxyguanosine in 24-hour urine.
Measured: Oxidative damage to DNA will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Oxidative damage to proteins.
Analysis of serum carbonyl groups
Measured: Oxidative damage to protein will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Oxidative damage to lipids
analysis of malondialdehyde in plasma
Measured: Oxidative damage to lipids will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Blood analysis
serum carbonyls. It is measured in nmol / mg proteins
Measured: Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Blood analysis
Malondialdehyde in plasma
Measured: Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Blood analysis
Oxidized LDL.
Measured: Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Blood analysis
Antioxidant capacity.
Measured: Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Blood analysis
glutathione metabolism. It is measured in nmol / mg proteins
Measured: Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start8 Jan 2018
- Primary completion30 Jul 2018
- Study completion4 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798821
- Sponsor's protocol ID
- UCAM-CFE-0003
- Acronym
- BIO
- Status last verified
- Jan 2019
- First submitted
- 15 Mar 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sanchez Macarro M, Avila-Gandia V, Perez-Pinero S, Canovas F, Garcia-Munoz AM, Abellan-Ruiz MS, Victoria-Montesinos D, Luque-Rubia AJ, Climent E, Genoves S, Ramon D, Chenoll E, Lopez-Roman FJ. Antioxidant Effect of a Probiotic Product on a Model of Oxidative Stress Induced by High-Intensity and Duration Physical Exercise. Antioxidants (Basel). 2021 Feb 22;10(2):323. doi: 10.3390/antiox10020323.
PubMed 33671691
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Clinical Trial to Evaluate the Antioxidant Efficacy of a Product Probiotic in Research
- ClinicalTrials.gov ID
- NCT03798821
- Acronym / sponsor ID
- BIO / UCAM-CFE-0003
- Conditions
- Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 4 Jan 2019 (actual)
- First posted
- 10 Jan 2019 (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.
Determine the efficacy of the investigational product versus placebo in reducing stress oxidative during the performance of a physical exercise of a certain intensity and duration.
Detailed description
The effectiveness of a probiotic for oxidative stress after eight weeks of the product to study will be checked. the sample will be formed by cyclists that will submit to a baseline exercise and after the product is taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG), Dietary Supplement: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG)One capsule a day will be consumed. At breakfast for the six weeks. |
| Comparator | Placebo comparator | Dietary Supplement: maltodextrin and sucrose (PLACEBO)One capsule a day will be consumed. At breakfast for the six weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: between 18 and 45 years
- Sex: male, of Caucasian race, selected from the general population.
- Subjects that perform aerobic physical exercise between 2 and 4 times a week.
- Volunteers capable of understanding the clinical study, willing to grant consent informed in writing and to comply with the procedures and requirements of the study
Key exclusion criteria (10 listed)
- Subjects with a history of any chronic disease.
- History of bronchial asthma or chronic obstructive pulmonary disease, disease Reactive airways such as bronchial asthma, a history of bronchial asthma or severe chronic obstructive pulmonary disease.
- Sinus bradycardia, second or third degree of atrioventricular block, insufficiency manifest cardiac or cardiogenic shock.
- History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- Participation in another clinical trial in the three months prior to the study Lack of will or inability to comply with clinical trial procedures.
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 |
|---|---|---|
| Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG)six weeks of consumption | Dietary supplement | Experimental |
| Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG)six weeks of consumption | Dietary supplement | Experimental |
| maltodextrin and sucrose (PLACEBO)six weeks of consumption | Dietary supplement | Comparator |
Primary outcome
Oxidative damage to lipids
Time frame: Oxidative lipid damage will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
It will be measured by isoprostanes in urine 24 hours.
8 secondary outcomes
Oxidative damage to DNA
Time frame: Oxidative damage to DNA will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Oxidative damage to proteins.
Time frame: Oxidative damage to protein will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Oxidative damage to lipids
Time frame: Oxidative damage to lipids will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Blood analysis
Time frame: Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Blood analysis
Time frame: Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Blood analysis
Time frame: Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Blood analysis
Time frame: Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Blood analysis
Time frame: Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
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 10 Jan 2019.
- Derived from this study: PubMed 33671691Sanchez Macarro M, Avila-Gandia V, Perez-Pinero S, Canovas F, Garcia-Munoz AM, Abellan-Ruiz MS, Victoria-Montesinos D, Luque-Rubia AJ, Climent E, Genoves S, Ramon D, Chenoll E, Lopez-Roman FJ. Antioxidant Effect of a Probiotic Product on a Model of Oxidative Stress Induced by High-Intensity and Duration Physical Exercise. Antioxidants (Basel). 2021 Feb 22;10(2):323. doi: 10.3390/antiox10020323.
- Individual participant dataSharing planned: Undecided
Related trials for Oxidative Stress
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
RecruitingObservational study
Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease
Gaucher Disease Type I, Oxidative Stress
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG) and Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG) in people with Oxidative Stress, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 4 inclusion and 10 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 10 Jan 2019. 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 Spain. 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?
Oxidative damage to lipids (time frame: Oxidative lipid damage will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03798821, which also lists 1 linked publication.
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 10 Jan 2019.