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Limosilactobacillus Fermentum CRL 1446 - CONICET CASASCO
Sponsor: PINER Pastor Manfredi Winery
Summary
This research study aims to determine if a probiotic called Limosilactobacillus fermentum CRL 1446 can improve the health of people at risk for cardiovascular disease. The study will be conducted with volunteers who will randomly consume either the probiotic or a placebo (a capsule without the probiotic), without knowing which one they are taking. The researchers will analyze how the probiotic affects blood sugar control, body composition, inflammation, and oxidative stress. The goal is to determine if this beneficial bacterium, by influencing the gut microbiota, could be a new strategy to prevent or mitigate chronic heart diseases.
Official title: Biological Effects of the Consumption of Limosilactobacillus Fermentum CRL 1446 - CONICET in Volunteers With Cardiovascular Risk Factors
Key Details
Gender
All
Age Range
40 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-02-02
Completion Date
2027-07-21
Last Updated
2026-04-15
Healthy Volunteers
Yes
Conditions
Interventions
Limosilactobacillus fermentum 1446 CRL CONICET 2.20E+9 CFU
Acute phase: After randomization of the groups, patients will be instructed to take one capsule daily of Limosilactobacillus fermentum 1446 CRL CONICET 2.20E + 9 CFU (colony-forming units) with their main meal for 30 days. After a 15-day medication-free period, the groups will be crossed over and undergo another 30-day intervention. Following this phase, the acute intervention will be repeated with two capsules daily. Chronic phase: After randomization of the groups, patients will be instructed to take one capsule daily of Limosilactobacillus fermentum 1446 CRL CONICET 2.20E + 9 CFU with their main meal for 90 days. After a 15-day drug washout period, the groups will be crossed over, and patients who received a placebo will undergo a 90-day intervention with one daily capsule of Limosilactobacillus fermentum 1446 CRL CONICET 2.20E + 9 CFU with their main meal. Following this phase, the chronic intervention will be repeated with two capsules daily.
Placebo (inert excipient)
Acute phase: After the initial randomization, patients will be instructed to take one placebo capsule (inert excipient) daily with their main meal for 30 days. After a 15-day break, the intervention will be repeated with the arms crossed. Once the initial intervention is completed, the acute intervention will be repeated with two capsules daily. Chronic phase: After the initial randomization, patients will be instructed to take one placebo capsule (inert excipient) daily with their main meal for 90 days. After a 15-day break, the intervention will be repeated with the arms crossed. Once the initial intervention is completed, the chronic intervention will be repeated with two capsules daily.
Locations (2)
Raul Francisco Pastor
Buenos Aires, Buenos Aires City, Argentina
TIEMPO MEDICO Health Research Center
Buenos Aires, Argentina