Limosilactobacillus Fermentum CRL 1446 - CONICET CASASCO

NCT07530575 | Active Not Recruiting DMC

• 1 other identifier: 26122024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

Probiótic, Obesity, Cardiovascular Risk

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (6)

• 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

  150 days (acute) 390 days (chronic)

• Continuous glucose monitoring by transdermal sensor.

  150 days (acute) and 390 days (chronic)

• Measure of the body composition by impedance analysis

  150 days (acute) and 390 days (chronic)

• Measure of the oxidative stress

  390 days

• Measure of the antioxidant defenses

  390 days.

Study Arms (2)

Active intervention: Limosilactobacillus fermentum 1446 CRL CONICET 2.20E+9 CFU

EXPERIMENTAL

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

Placebo (inert excipient)

PLACEBO COMPARATOR

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)

Interventions

Placebo (inert excipient) DIETARY_SUPPLEMENT

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.

Placebo (inert excipient)

Limosilactobacillus fermentum 1446 CRL CONICET 2.20E+9 CFU DIETARY_SUPPLEMENT

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.

Active intervention: Limosilactobacillus fermentum 1446 CRL CONICET 2.20E+9 CFU

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers with the following conditions may be eligible:
• Blood glucose greater than 100 mg/dl or pharmacological treatment for high blood glucose levels;
• HDL cholesterol \< 40 mg/dl in men or \< 50 mg/dl in women, or pharmacological treatment for low HDL cholesterol levels;
• Blood triglycerides \> 150 mg/dl or pharmacological treatment for high triglyceride levels;
• Waist circumference \> 102 cm for men or \> 88 cm for women;
• Arterial pressure \> 130/85 mmHg;
• Sedentarism;
• Smoking habit.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PINER Pastor Manfredi Winery: lead

Study Sites (2)

Raul Francisco Pastor

Buenos Aires, Buenos Aires City, 1408, Argentina

Location

TIEMPO MEDICO Health Research Center

Buenos Aires, 1440, Argentina

Location

Related Publications (24)

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• Abeijon Mukdsi MC, Saavedra L, Gauffin Cano MP, Hebert EM, Medina RB. Draft Genome Sequence of the Feruloyl Esterase-Producing Strain Lactobacillus fermentum CRL1446, a Probiotic for Malnutrition. Genome Announc. 2018 May 24;6(21):e00225-18. doi: 10.1128/genomeA.00225-18.

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• Mukdsi MC, Cano MP, Gonzalez SN, Medina RB. Administration of Lactobacillus fermentum CRL1446 increases intestinal feruloyl esterase activity in mice. Lett Appl Microbiol. 2012 Jan;54(1):18-25. doi: 10.1111/j.1472-765X.2011.03166.x. Epub 2011 Nov 23.

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• Russo M, Fabersani E, Abeijon-Mukdsi MC, Ross R, Fontana C, Benitez-Paez A, Gauffin-Cano P, Medina RB. Lactobacillus fermentum CRL1446 Ameliorates Oxidative and Metabolic Parameters by Increasing Intestinal Feruloyl Esterase Activity and Modulating Microbiota in Caloric-Restricted Mice. Nutrients. 2016 Jul 7;8(7):415. doi: 10.3390/nu8070415.

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• Paulino do Nascimento LC, Lacerda DC, Ferreira DJS, de Souza EL, de Brito Alves JL. Limosilactobacillus fermentum, Current Evidence on the Antioxidant Properties and Opportunities to be Exploited as a Probiotic Microorganism. Probiotics Antimicrob Proteins. 2022 Oct;14(5):960-979. doi: 10.1007/s12602-022-09943-3. Epub 2022 Apr 25.

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• Russo M , Marquez A , Herrera H , Abeijon-Mukdsi C , Saavedra L , Hebert E , Gauffin-Cano P , Medina R . Oral administration of Lactobacillus fermentum CRL1446 improves biomarkers of metabolic syndrome in mice fed a high-fat diet supplemented with wheat bran. Food Funct. 2020 May 1;11(5):3879-3894. doi: 10.1039/d0fo00730g. Epub 2020 May 18.

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Related Links

• Argentina's Fourth National Risk Factor Survey 2018

MeSH Terms

Conditions

Dysbiosis; Obesity; Overweight; Hypertension; Diabetes Mellitus; Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Raul Francisco Pastor, MD

  TIEMPO MEDICO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr. Raúl Francisco Pastor

Model Details: two-arm, randomized, double-blind, and crossover design

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: April 15, 2026
• Study Start: February 2, 2026
• Primary Completion: April 10, 2026
• Study Completion (Estimated): July 21, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

AR (2)