Clinical trial

Limosilactobacillus Fermentum CRL 1446 - CONICET CASASCO

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07530575

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age40 Years to 65 Years

SexAll

Healthy volunteersAccepted

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

Full registry criteria

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. \-

Treatments and study arms

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.

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.

Primary outcomes

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.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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Raul Francisco Pastor🇦🇷 Buenos Aires, Buenos Aires City, Argentina

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TIEMPO MEDICO Health Research Center🇦🇷 Buenos Aires, Argentina

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