A Prospective, Multicentre, Randomised Clinical Study Evaluating the Effectiveness of Lacticaseibacillus Wild Type Strain on Lowering Blood Cholesterol Levels
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- LDL-c levels up to 10 weeks
研究概览
简要总结
This is a 12-week prospective, multicentre, randomised Phase 4 study to evaluate the effect of a wild type strain of Lacticaseibacillus in cholesterol of blood levels.
详细描述
The goal of this study is to evaluate the effect of a wild type strain of Lacticaseibacillus as an incorporated ingredient of oat powder in the improvement of low density lipoprotein levels. In the study will participate two groups of subjects, one group with receive the strain with oats for 2.5 months and the other a group of subjects will receive plain oats. During the study, the subjects will receive only the product of the study and no other intervention will be performed except the standard clinical practice. The subjects will perform 4 visits and their eligibility will be evaluated at the baseline visit by performing routine clinical and laboratory examinations. The subjects who will consent to participate in the study will be randomised 1:1 into one of the study arms (Lacticaseibacillus and oats vs. oats). At each follow-up visit, the standard clinical and laboratory tests for dyslipidemia will be performed at the hospital.
Following a treatment period of 10 weeks, a 2-week washout observational period will take place where subjects will not receive any product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Neither participant nor site investigator is aware for the product
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants of either sex with ages between 18 and 70 years (limits included).
- •Participants with serum LDL-C ≥116 mg/dl.
- •Body Mass Index (BMI) between 18.5 and 35 kg/m2 (limits excluded).
排除标准
- •Subjects who systematically receive any other lipid-lowering non-medicinal product, supplement or functional food such as ACTIMEL, ACTIVIA, oat beta-glucan, pharmaceutical garlic, or stopped less than 1 month prior to study inclusion.
- •Participants that have been under lipid-lowering drug treatment (e.g. statins, fibrates, etc.) or any other medication that has a significant effect on LDL-c within the last 2 months prior to study inclusion.
- •Lactating females or those that are planning pregnancy within 6 months from the start of the study.
- •Participants with a history of ischemic cardiovascular events, alcohol abuse, or suffering from a severe chronic disease (e.g. cancer, diabetes, chronic advanced kidney disease, thyroid disorders, hepatic disorders, cancer, familial hypercholesterolemia or immunosuppression) that would potentially affect the outcomes of the study.
- •Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
- •Subjects with a known intolerance or allergy to any ingredient of the administered products.
- •Participants who are planning on making significant changes in their diet, lifestyle, and physical activity during the duration of the study, i.e. participants that are currently on weight-reducing diets.
- •Participants who are receiving any interventional procedure or are currently included in a clinical study.
结局指标
主要结局
LDL-c levels up to 10 weeks
时间窗: At 10 weeks after treatment initiation
Change in LDL-c levels from baseline at 10 weeks
次要结局
- Changes in SCORE 2 levels(At 10 weeks after treatment initiation)
- LDL-c levels up to 12 weeks(At 6 and 12 weeks after treatment initiation)
- Serious adverse events evaluation(Up to 12 weeks after treatment initiation)
- HDL-c, total cholesterol, and TG levels measurement(At 6, 10 and 12 weeks after treatment initiation)
- Subjects adherence to study(Up to 10 weeks)
研究者
Yiannis Kourkoutas
Laboratory of Applied Microbiology & Biotechnology
Democritus University of Thrace