Limosilactobacillus Fermentum CRL 1446 - CONICET CASASCO

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.

Conditions

• Disbiosis
• Obesity
• Overweight (BMI > 25)
• Hypertension (Without Type 2 Diabetes Mellitus)
• Diabetes (DM)
• Smoke
• Sedentarity
• Cholesterol (Total and HDL)
• Triglycerides High
• Stress (Psychology)

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

• National Council of Scientific and Technical Research, Argentina

  collaborator OTHER_GOV

• TIEMPO MEDICO Health Research Center

  collaborator UNKNOWN

• PINER Pastor Manfredi Winery

  lead INDUSTRY

Principal Investigators

• Raul Francisco Pastor, MD · TIEMPO MEDICO

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

40 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-02

Primary Completion

2027-07-21

Completion

2027-07-21

Countries

• Argentina

Study Locations