Biological Effects of the Consumption of Limosilactobacillus Fermentum CRL 1446 - CONICET in Volunteers With Cardiovascular Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Limosilactobacillus fermentum 1446 CRL CONICET 2.20E+9 CFU (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.
干预措施: Placebo (inert excipient) (Dietary Supplement)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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.)
- Measure of the chronic inflammation(390 days)
研究者
Raul Francisco Pastor
Prof Dr. Raúl Francisco Pastor
PINER Pastor Manfredi Winery