Limosilactobacillus Fermentum CRL 1446 - CONICET CASASCO

May 11, 2026 updated by: Raul Francisco Pastor, PINER Pastor Manfredi Winery

Biological Effects of the Consumption of Limosilactobacillus Fermentum CRL 1446 - CONICET in Volunteers With Cardiovascular Risk Factors

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The clinical study protocol, titled "Biological Effects of Consuming Limosilactobacillus fermentum CRL 1446 CONICET in Volunteers with Cardiovascular Risk Factors" was issued in October 2025 in Version 3.

Rationale and Theoretical Background

The protocol is underpinned by the acknowledgment of the **key influence of the gut microbiota** on human health, especially concerning cardiovascular risk factors. Data from Argentina's Fourth National Risk Factor Survey indicates a rise in overweight and obesity from 49% in 2005 to 61.6% in 2018. Overweight and obesity, along with dyslipidemia, hypertension, insulin resistance, and chronic inflammation, are closely correlated with imbalances in the gut microbiota, known as dysbiosis, which elevates the risk of cardiovascular diseases. Dysbiosis is characterized by a reduction in bacterial diversity, an increase in pro-inflammatory bacteria, and a decrease in beneficial bacteria that produce short-chain fatty acids.

Nutritional intervention utilizing probiotics presents a promising alternative for modulating the gut microbiota's composition and function, thereby improving major cardiovascular risk factors. A probiotic is defined by FAO/WHO as "live microorganisms that, when administered in adequate amounts, confer a health benefit on the host".

The specific strain under investigation, **Limosilactobacillus fermentum CRL 1446**, demonstrates a singular combination of functional mechanisms that support its potential efficacy in individuals with cardiovascular risk factors. Preclinical assays have shown that administration of the feruloyl esterase-producing strain L. fermentum CRL1446 improves metabolic and oxidative parameters. It is capable of modulating the gut microbiota through the production of beneficial metabolites, enhancing the integrity of the intestinal barrier and reducing bacterial translocation. Furthermore, this strain positively affects lipid metabolism by regulating key enzymes involved in lipid synthesis and degradation. It also exhibits an immunomodulatory action observed in preclinical trials, promoting an anti-inflammatory profile by stimulating regulatory cytokines and decreasing pro-inflammatory mediators. The strain's dual anti-inflammatory and antioxidant effect is linked to an increase in endogenous antioxidant enzymes like superoxide dismutase and glutathione peroxidase, suggesting a capacity to counteract cellular oxidative damage and potentially preserve endothelial function.

Research Question and Hypothesis

The primary research question is whether the consumption of L. fermentum CRL1446 can induce improvements in the metabolic health of adult volunteers with cardiovascular risk factors, potentially preventing or mitigating non-communicable chronic diseases. The working hypothesis is that volunteers who consume L. fermentum CRL 1446 will exhibit significant improvements in their metabolic health compared to those who do not.

Objectives

The **general objective** is to assess the efficacy of the L. fermentum CRL1446 strain in preventing postprandial glucose peaks, modulating intracellular and plasma inflammatory and redox status, and altering body composition, in volunteers receiving both acute (up to 30 days) and chronic (from 90 days) nutritional interventions.

**Specific objectives** include:

  1. Evaluating gastrointestinal symptomatology using the GSRS scale in 80 volunteers during the acute and chronic intervention phases.
  2. Evaluating postprandial glucose absorption levels and body composition changes in 30 volunteers before and after of consuming 1 capsule/day and 2 capsules/day of L. fermentum CRL1446, compared to placebo. Acute intervention phase.
  3. Evaluating postprandial glucose absorption levels and body composition changes in 50 volunteers before and after of consuming 1 capsule/day and 2 capsules/day of L. fermentum CRL1446, compared to placebo. Chronic intervention phase.
  4. Evaluating the modification of biomarkers for oxidative stress, antioxidant defenses, DNA damage, and chronic inflammation in 50 volunteers before and after of consumption (1 capsule/day and 2 capsules/day), compared to placebo. Chronic intervention phase.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1440
        • TIEMPO MEDICO Health Research Center
    • Buenos Aires City
      • Buenos Aires, Buenos Aires City, Argentina, 1408
        • Raul Francisco Pastor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Volunteers with the following conditions may be eligible:

  1. Blood glucose greater than 100 mg/dl or pharmacological treatment for high blood glucose levels;
  2. HDL cholesterol < 40 mg/dl in men or < 50 mg/dl in women, or pharmacological treatment for low HDL cholesterol levels;
  3. Blood triglycerides > 150 mg/dl or pharmacological treatment for high triglyceride levels;
  4. Waist circumference > 102 cm for men or > 88 cm for women;
  5. Arterial pressure > 130/85 mmHg;
  6. Sedentarism;
  7. Smoking habit.

Exclusion Criteria:

Patients with a history of digestive surgeries, inflammatory bowel disease, patients with gastroenteritis in the last 6 months, cancer patients, patients with rheumatic pathologies, patients with liver disorders, immunological disorders or deficiencies, steatorrhea, antibiotic use in the last 3 months, or anemia of any cause or pregnancy/expectation of becoming pregnant during the study.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active intervention: Limosilactobacillus fermentum 1446 CRL CONICET 2.20E+9 CFU

Acute phase: After the first randomization, 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 break, the intervention will be repeated with the crossed arms. Once the first intervention is completed, the acute intervention will be repeated with two capsules per day.

Chronic phase: After the second randomization, 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 90 days. After a 15-day break, the intervention will be repeated with the crossed arms. Once the first intervention is completed, the chronic intervention will be repeated with two capsules per day.
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.
Placebo Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the effects on gastrointestinal well-being and molecular biology by the consumption of Limosilactobacillus fermentum CRL 1446 CONICET 2.20E+9 CFU in volunteers with cardiovascular risk factors.
Time Frame: 150 days (acute) 390 days (chronic)
The researchers propose to thoroughly evaluate the effects on gastrointestinal well-being, glucose metabolism and redox metabolism (oxidative stress, endogenous antioxidant defenses and chronic inflammation) in participants with cardiovascular risk factors, with the aim of determining the impact of the Limosilactobacillus fermentum CRL 1446 CONICET strain on the prevention of cardiovascular diseases.
150 days (acute) 390 days (chronic)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weekly survey on gastrointestinal well-being, tolerance, side effects and/or adverse effects in participants with cardiovascular risk factors, from the acute and chronic consumption of Limosilactobacillus Fermentum CRL 1446 CASASCO CONICET
Time Frame: 150 days (acute) 390 days (chronic)

Gastrointestinal symptoms;

  1. Health effects
  2. Tolerance
  3. Side effects
  4. Adverse effects.

Method: Using the Gastrointestinal Symptom Rating Scale (GSRS). Units: Score on a scale of 1 to 7 described below on 15 different items

  1. No discomfort at all
  2. Minor discomfort
  3. Mild discomfort
  4. Moderate discomfort
  5. Moderately severe discomfort
  6. Severe discomfort
  7. Very severe discomfort
150 days (acute) 390 days (chronic)
Continuous glucose monitoring by transdermal sensor.
Time Frame: 150 days (acute) and 390 days (chronic)

Monitoring biomarkers:

  1. Glucosa in mg/dL
  2. Glucose Control Index (GCI) in percentage %.

The Glucose Control Index (GCI) is an estimate of HbA1c based on the average glucose level over the past 10 to 14 days, obtained through continuous glucose monitoring (CGM/Flash). Unlike laboratory-derived HbA1c, the GCI provides short-term information to assess current control and adjust treatment.

Calculation: It is derived directly from the daily average glucose recorded by a sensor, which generally requires at least 5-7 days of data.

Formula: The formula used is: GCI in % = 3.31 + 0.02392 x glucose in mg/dL.
150 days (acute) and 390 days (chronic)
Measure of the body composition by impedance analysis
Time Frame: 150 days (acute) and 390 days (chronic)

Biomarkers:

  1. Muscle mass in kg
  2. Fat mass in kg
150 days (acute) and 390 days (chronic)
Measure of the oxidative stress
Time Frame: 390 days

Biomarkers:

  1. Lipid peroxidation in nmol/mg of protein.
  2. Carbonylated proteins in nmol/mg of protein.
  3. 8(OH)dG in ng/mL.
390 days
Measure of the antioxidant defenses
Time Frame: 390 days.

Biomarkers:

  1. Total Antioxidant Status in mEqTROLOX/mL
  2. Glutathione in nmol/mg of protein
390 days.
Measure of the chronic inflammation
Time Frame: 390 days

Biomarkers:

  1. Ferritin in ng/mL
  2. Haptoglobin in mg/mL
  3. High-sensitivity PCR in mg/dL
390 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PINER Pastor Manfredi Winery

Collaborators

National Council of Scientific and Technical Research, Argentina
TIEMPO MEDICO Health Research Center

Investigators

  • Principal Investigator: Raul Francisco Pastor, MD, TIEMPO MEDICO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2026

Primary Completion (Estimated)

July 21, 2027

Study Completion (Estimated)

July 21, 2027

Study Registration Dates

First Submitted

August 28, 2025

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26122024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe