Effects of the Probiotic AB-LIFE on the Amount and Profile of Bile Acids, and the Lipid and Metabolic Profile in Healthy Overweight Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from Baseline Lipid profile at 7 days
研究概览
简要总结
Moderate hypercholesterolemia, metabolic alterations derived from overweight or obesity, and consequently and their related cardiovascular risks can be reduced through changes in lifestyle. A growing body of evidence shows a relationship between hypercholesterolemia and dysfunction of the gut microbiota.
Gut microbiota is considered a keystone in maintaining the health condition of the host through multiple mechanisms affecting different metabolic processes, including lipid metabolism and cholesterol-related pathways. Bile acids (BA) are cholesterol-derived compounds synthesized in the liver and metabolized upon modification by gut bacteria once they reach the colon.
Conversely, BAs shape the composition and function of the intestinal microbiota. This mutual interplay between BAs and gut microbiota regulates many physiological processes, including the lipid, carbohydrate and energy metabolism of the host.
Previous studies based on Lactobacillus plantarum have shown 3 strains CECT 7527, 7528, and 7529 with the ability to adhere to the intestinal mucosa with very low toxicity, what makes them susceptible to be used as a probiotic. The lipid-lowering effect of the 3 bacteria strains was already evidenced in previous preclinical studies in animal models and clinical studies in hypercholesterolemic subjects. Up to now, however, little is known about the effects of the 3- combined Lactobacillus plantarum strains on levels and profile of bile acids in healthy overweight subjects, otherwise at low cardiovascular risk.
The aim of this study is to explore on the mechanism of action of a Lactobacillus plantarum mixture (CECT 7527, CECT 7528 and CECT 7529) and evaluate the effect of this probiotic formulation on BA profile as well as on plasma lipids and other related biomarkers when administered in a dose-dependent regime in a cohort of overweight subjects.
The probiotic product was administrated for 4 weeks with a weekly dose-regime of 2x, 3x, and 4x, respectively, in the second, third, and fourth week in relation to the first week. The effects were evaluated on: (1) level and profile of bile acids in plasma and feces, (2) plasma lipid/lipoprotein and fatty acid profile and (3) endocrine hormones, glucose metabolism and inflammatory markers in plasma.
详细描述
Sample size (N=20) was calculated according results of previous studies on plasma bile acids. The study refers to healthy overweight [body mass index (BMI) 25.0-29.9 kg/m2] adult men (N=10) and women (N=10) between the ages of 25 and 60 years.
The study was approved by the Human Ethical Review Committee of the Hospital Sant Pau in Barcelona (register number: 20/029). Informed written consent was obtained from all participants before their inclusion in the study. To confirm health status, all subjects underwent a complete physical examination conducted by the study physician.
The study lasted 6 weeks that were structured in:
-
2 weeks of run-in.
-
4 weeks of intervention period divided into 4 phases of 7 days. During the intervention period, Lactobacillus plantarum capsules were consumed according to the following pattern:
-
Days 0-6: 1 capsule/day
-
Days 7-13: 2 capsules/day
-
Days 14-20: 3 capsules/day
-
Days 21-27: 4 capsules/day
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass index (BMI): Between 25 and 30 Kg / m2
排除标准
- •Eating disorders.
- •Subjects with cardiovascular risk factors such as hypercholesterolemia (genetic or secondary), hypertension and diabetes, treated pharmacologically.
- •History of ischemic heart disease (and / or previous angina or AMI) or arrhythmia (current or previous).
- •Previous strokes and / or peripheral vascular disease.
- •Alcohol consumption greater than 60 gr / day.
- •Kidney failure (creatinine> 2 mg / dl).
- •Presence of neoplasia.
- •Presence of systemic disease.
- •Psychiatric illness under treatment with psychotropics.
- •Unstabilized thyroid disease.
- •Having followed or being following a hypocaloric diet or regularly consumed dietary supplements for weight or constipation or cholesterol control (plant sterols, soy lecithin, omega-3 fatty acids) for 2 months prior to inclusion in the study.
- •Pregnancy or breastfeeding.
- •In current treatment with non-steroidal anti-inflammatory drugs, antiplatelet agents, fibrates or statins.
结局指标
主要结局
Change from Baseline Lipid profile at 7 days
时间窗: At days 0 and 7
By standardized biochemical techniques
Change from Baseline Lipid profile at 21 days
时间窗: At days 0 and 21
By standardized biochemical techniques
Change from Baseline Serum bile acids at 14 days
时间窗: At days 0 and 14
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Change from Baseline Serum bile acids at 28 days
时间窗: At days 0 and 28
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Change from Baseline Lipid profile at 14 days
时间窗: At days 0 and 14
By standardized biochemical techniques
Change from Baseline Lipid profile at 28 days
时间窗: At days 0 and 28
By standardized biochemical techniques
Change from Faecal bile acids at 28 days
时间窗: At days 0 and 28
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Change from Baseline Plasmatic endocrine hormones and metabolic markers at 28 days
时间窗: At days 0 and 28
By Enzyme-Linked immunosorbent Assay (ELISAs)
Change from Baseline Faecal fatty acids at 28 days
时间窗: At days 0 and 28
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Change from Baseline Serum fatty acids at 14 days
时间窗: At days 0 and 14
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Change from Baseline Serum fatty acids at 28 days
时间窗: At days 0 and 28
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Change from Baseline Serum lipoprotein profile at 28 days
时间窗: At days 0 and 28
By nuclear magnetic resonance (NMR)
Change from Baseline Plasmatic endocrine hormones and metabolic markers at 14 days
时间窗: At days 0 and 14
By Enzyme-Linked immunosorbent Assay (ELISAs)
Change from Baseline Serum lipoprotein profile at 14 days
时间窗: At days 0 and 14
By nuclear magnetic resonance (NMR)
次要结局
- Change from Baseline Plasmatic Inflammatory markers at 14 days(At days 0 and 14)
- Change from Baseline LDL susceptibility to oxidation and HDL antioxidant capacity at 28 days(At days 0 and 28)
- Change from Baseline LDL susceptibility to oxidation and HDL antioxidant capacity at 14 days(At days 0 and 14)
- Change from Baseline Plasmatic Inflammatory markers at 28 days(At days 0 and 28)
- Change from Baseline Serum Vitamin D and thyroid hormones (TSH, T3 & T4) at 14 days(At days 0 and 14)
- Change from Baseline Serum Vitamin D and thyroid hormones (TSH, T3 & T4) at 28 days(At days 0 and 28)