Effect of Meat and Egg on TMAO in Plasma and Urine in Subjects with and Metabolic Subjects
- Conditions
- Metabolic Syndrome X
- Registration Number
- NCT06660251
- Lead Sponsor
- Linnaeus University
- Brief Summary
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.
- Detailed Description
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.
Blood samples were collected (before ingestion of food, and at 30, 60, 120, 240, and 360 minutes after ingestion). A composite urine sample was collected over 6 hours. A feces sample was collected on the day before the first intervention.
Concentrations of TMAO, trimethylamine, betaine, choline, L-carnitine, acetyl-L-carnitine, and creatinine were measured UPLC-MRM-MS. The incremental area under the curve (iAUC) was calculated for each compound.
TMAO, trimethylamine, betaine, choline, L-carnitine, acetyl-L-carnitine, and creatinine were analyzed in composite urine samples using UPLC-MRM-MS.
Gut microbiome analysis was done by full 16S rRNA gene sequencing using the Oxford Nanopore Technology.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method TMAO and related metabolite concentrations (micromole per litre) in plasma 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 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.
- Secondary Outcome Measures
Name Time Method Gut microbiota composition The day before the first intervention day. Gut microbiota composition in a stool sample collected on the day before the first intervention was analyzed by a full 16S rRNA gene sequencing kit from Oxford Nanopore Technology.
Blood glucose and glycated hemoglobin At screening (before intervention). Fasting blood glucose and glycated hemoglobin (millimoles per liter mmol/l) were analyzed at screening.
Plasma lipid profile At screening (before intervention). Plasma cholesterol, plasma high-density lipoprotein cholesterol, plasma cholesterol, and plasma triglycerides concentrations (millimoles per liter mmol/l) were analyzed at screening.
Body mass index (BMI) At screening (before intervention). Weight in kilograms and height in meters were measured at screening and used to calculate BMI in kilograms per square.
Trial Locations
- Locations (1)
Faculty of Health and Life Sciences, Linnaeus University
🇸🇪Kalmar, Sweden