The Antioxidant Efficacy of a Product Probiotic in Research

NCT03798821 | Completed

• 1 other identifier: UCAM-CFE-0003
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oxidative Stress

Outcome Measures

Primary Outcomes (1)

• Oxidative damage to lipids

  It will be measured by isoprostanes in urine 24 hours.

  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

  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.

  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

  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

  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

  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.

Study Arms (2)

Experimental

EXPERIMENTAL

One capsule a day will be consumed. At breakfast for the six weeks.

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.

Dietary Supplement: maltodextrin and sucrose (PLACEBO)

Interventions

Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG) DIETARY_SUPPLEMENT

six weeks of consumption

Experimental

Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG) DIETARY_SUPPLEMENT

six weeks of consumption

Experimental

maltodextrin and sucrose (PLACEBO) DIETARY_SUPPLEMENT

six weeks of consumption

Comparator

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

Related Publications (1)

• 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.

  PMID: 33671691 DERIVED

MeSH Terms

Interventions

maltodextrin; Sucrose

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, 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 15, 2018
• First Posted: January 10, 2019
• Study Start: January 8, 2018
• Primary Completion: July 30, 2018
• Study Completion: January 4, 2019
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

ES (1)