Biomarkers of Oat Product Intake: The BiOAT Marker Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Plasma concentrations of avenanthramides and avenacosides and their metabolites.
研究概览
简要总结
The aim of this project is to evaluate avenanthramides and avenacosides and their metabolites as specific biomarkers of oat product intake in humans. Biomarkers will be evaluated after i) a single dose through a single meal based on a solid and a liquid oat-based product (pharmacokinetic study) ii) week-long consumption at three different intake levels (dose-response). The study will be carried out as a two-way cross-over design with two different oat products, liquid or solid, where each product is provided 3 times per day during 5 days per product. A wash-out period of 8 days where participants consume their habitual diet is implemented. The first day of study meal intervention includes postprandial measurements during 8 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females and males
- •Age 18-80 years
- •Body mass index (BMI) 18.5-30 kg/m2
- •Fasting glucose ≤ 6.1 mmol/l
- •Low density lipoprotein (LDL) Cholesterol ≤ 5.30 mmol/L
- •Triglycerides ≤ 2.60 mmol/L
- •Signed informed consent
排除标准
- •Food allergies or intolerances preventing consumption of any products included in the study.
- •Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personal.
- •Pregnant, lactating or planning a pregnancy during the study period.
- •Antibiotic use for the last 3 months.
- •Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
- •History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
- •Previous major gastrointestinal surgery
- •Have type I diabetes
- •Thyroid disorder
结局指标
主要结局
Plasma concentrations of avenanthramides and avenacosides and their metabolites.
时间窗: 24 hours
Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average plasma concentration over a 24 h period).
Plasma concentration-time profile over 24h (AUCs) of avenanthramides and avenacosides and their metabolites.
时间窗: 24 hours
Differences in plasma AUCs between the intake levels for each biomarker candidate.
Urine concentrations of avenanthramides and avenacosides and their metabolites
时间窗: 8 hours
Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average urine concentration over a 8 h period).
次要结局
- Urine metabolites(24 hours)
- Blood concentrations of avenanthramides and avenacosides and their metabolites(8 hours)
- Gut microbiome(5 days)
- Plasma metabolites(5 days)
研究者
Rikard Landberg
Professor
Chalmers University of Technology