Bile Acids As Determinants of Postprandial Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Plasma markers of intermediate metabolism and inflammation
研究概览
简要总结
This study aims to understand how bile acids (BAs) appear in the bloodstream after eating and how this might affect inflammation and metabolism. To do this, we will measure changes in BA levels in 100 healthy women after they eat a high-fat and high-carbohydrate meal. Blood samples (a small amount of 500 µL) will be collected from a finger prick at 7 time points over 5 hours. In the second part of the study, 40 women will be invited back-20 with the highest and 20 with the lowest increases in BAs. These participants will eat the same test meal, and blood samples will be taken from a vein to study markers of health, metabolism, inflammation, and the gut microbiome. By exploring how BAs work in the body, this study hopes to find new ways to understand and prevent chronic diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged between 18 and 70 years
- •Body mass index (BMI) between 18.5 and 34.9 kg/m²
排除标准
- •Pregnant women
- •History of bariatric surgery and/or intestinal resection
- •Inflammatory bowel disease
- •Celiac disease
- •Liver disease
- •Type 2 diabetes mellitus
- •Casein allergy
- •Alcohol consumption >30 g/day
- •Use of antimicrobial therapy within the past two months
- •Note: The use of dietary supplements was not considered an exclusion factor. The use of medication for the treatment of chronic diseases was evaluated on a case-by-case basis and did not constitute, a priori, an exclusion factor.
结局指标
主要结局
Plasma markers of intermediate metabolism and inflammation
时间窗: 1 day
Capillary blood samples (approximately 200 µL) were collected after a 12-hour fasting period and at different time points within a 5-hour interval after food intake to assess plasma metabolic and inflammatory markers, such as cytokines (IL-6 and TNF-α \[pg/mL\]), glucose levels \[mg/dL\], lipid profile parameters, including triglycerides, total cholesterol, and fractions \[mg/dL\], as well as bile acids \[µmol/L\]. These measurements aim to identify the physiological and metabolic responses to food intake.
Cytokines
时间窗: 1 day
IL-6 and TNF-α \[pg/mL\]
Glucose levels
时间窗: 1 day
glucose levels \[mg/dL\]
Lipid profile parameters
时间窗: 1 day
triglycerides, total cholesterol, and fractions \[mg/dL\].
Bile Acids
时间窗: 1 day
bile acids \[µmol/L\]
次要结局
- Urine metabolome(1 day)
- 24-hour dietary(1 day)
- Food Frequency Questionnaire (FFQ)(1 day)
- Visual Analog Score (VAS)(1 day)
研究者
Jarlei Fiamoncini
Professor PhD
University of Sao Paulo