Metabolic Syndrome XNCT06660251
Effect of Meat and Egg on TMAO in Plasma and Urine in Subjects with and Metabolic Subjects
A study testing Egg intervention and Meatball intervention in people with Metabolic Syndrome X, run by Linnaeus University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- Egg intervention and Meatball intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSweden
- Study dates
- 7 Feb 2020to 5 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 17Show fewer
- No pregnancy, planned conception, or lactation
- No participation in another study.
- 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
- 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.
Who cannot join
- Smoker
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Faculty of Health and Life Sciences, Linnaeus University
Kalmar, 392 31
About this study
Official title: Trimethylamine-N-oxide After Animal Food - Effects of Gut Microbiota in Subjects with and Without Metabolic Syndrome
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.
Read the 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.
- Conditions
- Metabolic Syndrome X
- Being tested
- Egg intervention, Meatball intervention
- Keywords
- Metabolic syndrome, TMAO, Gut microbiota, Egg and meat, Plasma, Urine
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg interventionOther
Oral administration of three hard-boiled eggs to be ingested within 15 minutes on one occasion.
Meatball interventionOther
Oral intervention with 170 g meatballs to be ingested within 15 minutes on one occasion.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with MetS | Active comparator | 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. Receives: Other: Egg intervention; Other: Meatball intervention |
| Subjects without MetS | Active comparator | 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. Receives: Other: Egg intervention; Other: Meatball intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Post-dose sample over a 6-hours period.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At screening (before intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start7 Feb 2020
- Primary completion5 May 2023
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, crossover intervention with two active groups (subjects with and without MetS) using two test foods (egg and meat, with high content of TMAO precursors) was carried out.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linnaeus University
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University
- Responsible party
- Principal investigator, Mohammed Hefni, Linnaeus University
- Investigators
- Mohammed E Hefni, Assoc Prof, Principal investigator, Linnaeus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660251
- Sponsor's protocol ID
- 2019-04354
- Other IDs
- 2019
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trimethylamine-N-oxide After Animal Food - Effects of Gut Microbiota in Subjects with and Without Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT06660251
- Acronym / sponsor ID
- 2019-04354
- Conditions
- Metabolic Syndrome X
- Keywords
- Metabolic syndrome, TMAO, Gut microbiota, Egg and meat, Plasma, Urine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Linnaeus UniversityUniversity, hospital or other
- Collaborators
- Umeå University
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, crossover intervention with two active groups (subjects with and without MetS) using two test foods (egg and meat, with high content of TMAO precursors) was carried out.
| Arm | Type | Receives |
|---|---|---|
| Subjects with MetS | Active comparator | Other: Egg intervention, Other: Meatball interventionSubjects 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. |
| Subjects without MetS | Active comparator | Other: Egg intervention, Other: Meatball interventionSubjects, 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (7 listed)
- Smoker
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Egg interventionOral administration of three hard-boiled eggs to be ingested within 15 minutes on one occasion. | Other | Subjects with MetS, Subjects without MetS |
| Meatball interventionOral intervention with 170 g meatballs to be ingested within 15 minutes on one occasion. | Other | Subjects with MetS, Subjects without MetS |
Primary outcome
TMAO and related metabolite concentrations (micromole per litre) in plasma
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 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
Time frame: 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.
4 secondary outcomes
Gut microbiota composition
Time frame: The day before the first intervention day.
Blood glucose and glycated hemoglobin
Time frame: At screening (before intervention).
Plasma lipid profile
Time frame: At screening (before intervention).
Body mass index (BMI)
Time frame: At screening (before intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed E Hefni, Assoc Prof principal investigator
Linnaeus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg intervention and Meatball intervention in people with Metabolic Syndrome X, run by Linnaeus University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TMAO and related metabolite concentrations (micromole per litre) in plasma (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.