UOC DI GASTROENTEROLOGIA AOU S.GIOVANNI DI DIO E RUGGI D'ARAGONA (Italy) & University of Roehampton (UK)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Change in blood cholesterol levels
研究概览
简要总结
Recent studies have also shown that 30% of the world's population carries the susceptibility genes for coeliac disease and that only 2-5% of these individuals are really affected, however, studies suggest the existence of other factors capable of contributing to the onset of the disease, such as intestinal dysbiosis. We have also seen how each of us has a specific microbiota, defined as an individual human enterotype, which depends on our background and can be modified by the diet. Recently, much interest has been directed to a strain of lactobacilli, called Lactobacillus plantarum (LP-LDL®) capable of reducing cholesterol and preventing the reabsorption of bile salts in the liver. The efficacy of this bacterial strain has been confirmed in 3 different human studies demonstrating the efficacy of LP-LDL® in patients with high baseline cholesterol (TC> 6mmol / L). This is a food supplement that has been commercially available in multiple formulations in Europe for over 3 years. LP-LDP is a probiotic strain, safe to use, selected for its high bile salt hydrolase in vitro, and in vivo cholesterol reduction activity. The intake of 2 Å~ 109 CFU encapsulated LP-LDL twice daily, significantly reduced LDL-C (13.9%), total cholesterol (TC) (37.6%), TG (53.9%), and significantly increased HDL-C (14.7%; in subjects >60 years of age; 6-12 weeks) in normal to mildly hypercholesterolaemic subjects. In a recent double-blind placebo-controlled human study published by the Journal of Functional Foods (2022) and carried out by the University of Roehampton (UK), LPLDL showcased statistically significant reductions in multiple cardiovascular risk biomarkers, including total cholesterol, LDL cholesterol, non-HDL cholesterol and apoB. No adverse effects were noted throughout the study.
We are here proposing a pilot human intervention study to evaluate the effectiveness of the LP-LDL® probiotic in reducing cardiovascular risk factors inclusive of cholesterol in the blood in people with coeliac disease.
详细描述
A total of 50 coeliac subjects (+/- 6 additional volunteers) will be recruited to achieve statistical significance with changes on a logarithmic scale of 1.2 for cholesterol based on other interventional studies using focused probiotics on the reduction of the lipid picture. Based on these calculations, 10 coeliac subjects are required for each study group. The Mann-Whitney U test will be used to compare variables that are not normally distributed. GraphPad Prism Version 9.0 (GraphPad Software, Inc., San Diego, CA, USA) will be used for statistical analysis. All patients with coeliac disease will be recruited at Roehampton until the set target by the Protocol (at least 25 patients will be enrolled). This is to ensure we have an acceptable number of patients that can be monitored, net of subjects lost to follow up (drop-out). A random generator (GraphPad QuickCalcs, San Diego, CA, USA) will be used in order to assign a specific number to each patient and ensure double-blind randomization of the 50 patients in two study groups. Patients will be stratified by gender and randomly assigned to one of the two treatment groups using a 2: 1 ratio due to the higher prevalence of female sex in coeliac patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged between 18 and 65 years, with CD Diagnosis
- •Fasting blood glucose level not above 5.6-6.9mmol/L
- •High baseline cholesterol (TC> 6mmol / L).
- •HbA1c below 5.7%
- •With cholesterol
- •For intervention purposes, eligible participants are also required to have a mobile phone and be able to read and speak English.
排除标准
- •People with comorbid conditions that may limit participation in the study, such as a history of an acute cardiovascular event, uncontrolled hypertension, cancer or major psychiatric or cognitive problems
- •People who are already participating in a weight loss programme
- •People receiving drug treatment for lipid metabolisms (e.g., statins
- •People with a history of long-term use of medicines known to influence glucose metabolism (e.g., corticosteroids)
- •People with elevated liver enzymes (alanine aminotransferase ≥300 IU/L, aspartate aminotransferase ≥300 IU/L)
- •People who take antibiotics or bacterial agents (Probiotics) within 1 month
- •Pregnant women, women ready for pregnancy, and nursing mothers
- •All capsules (probiotic and placebo) have the same taste and appearance and have been mixed, encapsulated and packaged to ensure product consistency throughout the study. All capsules will be distributed free of charge to participants in this study.
研究组 & 干预措施
Probiotic
Lactobacillus plantarum (LPLDL®) equivalent to 4 x10^9 CFU (0.1 g) with the addition of filling carrier (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed once a day, after lunch with 250mL of water.
干预措施: LP-LDL Probiotic (Dietary Supplement)
placebo
Maltodextrin (an oligosaccharide without prebiotic effect) (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed once a day, after lunch with 250mL of water.
干预措施: Placebo Comparator (Dietary Supplement)
结局指标
主要结局
Change in blood cholesterol levels
时间窗: Change from baseline to 6 and 9 weeks of the intervention
To test, in humans, whether LPLDL® intervention lowers total cholesterol compared to the baseline levels
Change in BMI (body mass index) Scores
时间窗: Change from baseline to 6 and 9 weeks of the intervention
To test wheter LPLDL® intervention affect body mass indes in kg/m\^2
次要结局
- Change in VitD levels(Change from baseline to 6 and 9 weeks of the intervention)
- Change in the gut microbiota diversity(Change from baseline to 6 and 9 weeks of the intervention)
- Change in ApoB concentration(Change from baseline to 6 and 9 weeks of the intervention)
- Change in dietary habits(Change from baseline to 6 and 9 weeks of the intervention)
研究者
DR ADELE COSTABILE
Study PI
University of Roehampton