Trimethylamine-N-oxide After Animal Food - Effects of Gut Microbiota in Subjects with and Without Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- TMAO and related metabolite concentrations (micromole per litre) in plasma
研究概览
简要总结
The purpose of this clinical trial is to investigate in subjects with and without metabolic syndrome how meals of choline- and carnitine-rich foods (eggs and meat) affect the trimethylamine-N-oxide (TMAO) concentration in blood and urine in relation to the gut microbiota composition.
In response to the subjects´ gut microbiota, the concentrations of TMAO in the plasma and urine of subjects with and without metabolic syndrome (MetS) after ingesting choline- and carnitine-rich foods will be compared.
On two occasions, participants will receive after overnight fasting meatballs (170 g) or three hard-boiled eggs. Blood will be collected before ingestion and over 6 hours after test food consumption.
详细描述
There is a growing interest in the role of the intestinal microbiota in the global metabolism of their host. Trimethylamine-N-oxide (TMAO), a metabolite linked to the gut microbiota, has recently emerged as a risk metabolite for cardiovascular disease.
The gut microbiota composition was reported to be altered in MetS. After ingestion of foods high in trimethylamine moieties, postprandial TMAO in blood may differ between subjects with and without MetS because of their different microbiota profiles.
Aim of the study is to investigate in subjects with and without MetS the postprandial TMAO concentrations in blood and urine in association with the gut microbiota profile after ingestion of choline- and L-carnitine-rich foods.
Thirty-three subjects aged 18-75 years with (n=12) or without MetS (n=21) were recruited.
Subjects received on two occasions, after overnight fasting, either three hard-boiled eggs or 170 g meatballs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for all subjects with and without MetS:
- •Age = 18-75y
- •Plasma creatinine value within the age-related reference range
- •No history of acute or chronic diseases (e.g. diabetes or bowel disease)
- •No use of vitamin or mineral supplements, no medication with antibiotics 2 months before recruitment and during the study
- •Non-smoker
- •Not consuming a special diet (vegetarian)
- •No pregnancy, planned conception, or lactation
- •No participation in another study.
- •Inclusion criteria for subjects without MetS:
- •Normal BMI (18.6 to 29.0 kg / m 2 )
- •Blood counts within reference ranges
- •Normal ranges for liver enzymes (P-ALAT, P-AST, P-ALP), blood status, plasma triglycerides, plasma HDL cholesterol, plasma cholesterol, plasma glucose
- •Inclusion criteria for subjects with MetS:
- •A minimum of three of the following criteria according the National Cholesterol Education Program Adult Treatment Panel (NCEP-ATP III):
- •Waist size > 102 cm in men, > 88 cm in women
- •Fasting plasma glucose ≥ 5.6 mmol /l
- •Triglycerides > 1.7 mmol / l or treatment
- •HDL 1.03 mmol / l in men, 1.29 mmol / l in women or treatment
- •Blood pressure ≥ 130 / 85 mm Hg or medication. A value of B-HbA1c in the age-related reference range will be used to exclude diabetes.
排除标准
- •for all research subjects :
- •Pregnancy, planned conception, or lactation
- •Medical treatment with antibiotics 2 months before recruitment and during the study
- •Use of dietary supplements 2 weeks before and during the study
- •Use of probiotics 2 months before and during the study
- •Following a special diet (eg vegan, vegetarian, weight loss)
- •Participation in another study
结局指标
主要结局
TMAO and related metabolite concentrations (micromole per litre) in plasma
时间窗: Metabolite concentrations in plasma samples collected before ingestion of test food and after ingestion at 30, 60, 120, 240, and 360 minutes are used for calculation the incremental area under the curve.
TMAO and related metabolites (trimethylamine, betaine, choline, L-carnitine, and acetyl-L-carnitine) were analyzed by UPLC-MRM-MS in plasma samples collected before ingestion of test food and after ingestion at 30, 60, 120, 240, and 360 minutes.
TMAO and related metabolite concentrations (micromole per litre) in urine
时间窗: Post-dose sample over a 6-hours period.
TMAO and related metabolites (trimethylamine, betaine, choline, L-carnitine, and acetyl-L-carnitine) were analyzed by UPLC-MRM-MS in a composite urine sample collected during 6 hours post-dose.
次要结局
- Gut microbiota composition(The day before the first intervention day.)
- Blood glucose and glycated hemoglobin(At screening (before intervention).)
- Plasma lipid profile(At screening (before intervention).)
- Body mass index (BMI)(At screening (before intervention).)
研究者
Mohammed Hefni
Assoc Prof
Linnaeus University