An interventional study of Egg intervention and Meatball intervention in Metabolic Syndrome X, sponsored by Linnaeus University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-28.
Sponsored by Linnaeus University · Not applicable, Interventional, and Basic science
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.
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.
2,011 studies on the registry are indexed under Metabolic Syndrome; 334 are open to participants now.
This study's enrollment of 33 is below the median of 60 across 1,494 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Linnaeus University is the lead sponsor of 28 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for all subjects with and without MetS:
Inclusion criteria for subjects without MetS:
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):
Exclusion criteria for all research subjects :
Subjects with a minimum of three criteria according to NCEP-ATP III. Subjects were administered in randomized order after overnight fasting a test food. Test days were on two separate occasions around 2 weeks apart. Egg intervention: three hard-boiled eggs. Meatball intervention: 170 g meatballs.
Other: Egg intervention · Other: Meatball intervention
Subjects, apparently healthy, with normal BMI, blood pressure, waist circumference (see inclusion criteria). Subjects were administered in randomized order after overnight fasting a test food. Test days were on two separate occasions around 2 weeks apart. Egg intervention: three hard-boiled eggs. Meatball intervention: 170 g meatballs.
Other: Egg intervention · Other: Meatball intervention
Oral administration of three hard-boiled eggs to be ingested within 15 minutes on one occasion.
Oral intervention with 170 g meatballs to be ingested within 15 minutes on one occasion.
TMAO and related metabolite concentrations (micromole per litre) in plasma
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.
Time frame: 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 metabolite concentrations (micromole per litre) in urine
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.
Time frame: Post-dose sample over a 6-hours period.
Gut microbiota composition
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.
Time frame: The day before the first intervention day.
Blood glucose and glycated hemoglobin
Fasting blood glucose and glycated hemoglobin (millimoles per liter mmol/l) were analyzed at screening.
Time frame: At screening (before intervention).
Plasma lipid profile
Plasma cholesterol, plasma high-density lipoprotein cholesterol, plasma cholesterol, and plasma triglycerides concentrations (millimoles per liter mmol/l) were analyzed at screening.
Time frame: At screening (before intervention).
Body mass index (BMI)
Weight in kilograms and height in meters were measured at screening and used to calculate BMI in kilograms per square.
Time frame: At screening (before intervention).
Plan to share: No — There is no plan to share individual data as all data will be presented in the main article through tables and figures or in the supplementary material as mean ± standard deviation. However, individual data will be made available upon reasonable request.
No publications or documents are linked to this record.
Ran from Feb 2020 to primary completion in May 2023, 38 months.
Of 594 non-industry interventional studies with no phase under Metabolic Syndrome, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 40. This study's 38 months is above that.
Counting every sponsor, half of 640 studies reached it within 20 months; a quarter within 9 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Linnaeus University