Biomarkers of Cardiovascular DiseaseNCT01906554
Plasma and Urine TMAO Formation and Changes to Oxidized LDL After Ingestion of Different Amounts of Egg
A study testing Egg Dose in people with Biomarkers of Cardiovascular Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Eggs contain an essential nutrient called choline and adequate levels of choline are required for good health. Studies in mice have demonstrated that high levels of choline may increase risk of heart disease through a process that involves the breakdown of choline by gut bacteria. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomarkers of Cardiovascular Disease
- What is being tested?
- Egg Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jul 2013
- 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
- Healthy
- non-smoker
- Body mass index between 20 to 39 kg/m²
Who cannot join
- History of chronic system disease/s (e.g., hepatic, renal, cardiovascular, intestinal)
- Diabetes controlled by insulin
- Alcohol or illegal drug misuse/abuse
- Use of antibiotics or choline-containing supplements within three months of study
- Allergies to soy, eggs, wheat or other food
- Use of drugs or medications known to alter liver metabolism, cardiovascular and/or kidney function
Show all 9Show fewer
- Abnormal physical examination or abnormal clinical laboratory values
- Pregnancy
- Unusual dietary habits
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill Nutrition Research Institute
Kannapolis, North Carolina, 28081
About this study
Official title: Determining Whether or Not Egg Ingestion Increases Concentrations of Trimethylamine N-oxide (TMAO) in Plasma and Urine and Activates LDL Oxidation in Humans
Eggs contain an essential nutrient called choline and adequate levels of choline are required for good health. Studies in mice have demonstrated that high levels of choline may increase risk of heart disease through a process that involves the breakdown of choline by gut bacteria. Previous research did not show that human consumption of eggs increases risk of heart disease. This study is designed to investigate whether the number of eggs in the diet affects blood and urine markers for heart disease.
Read the detailed description
Diets low in choline have adverse health consequences, while observations in humans and experiments in mouse models suggest that a diet containing too much choline or phosphatidylcholine may activate inflammatory pathways and increase cardiovascular disease risk through bacterial conversion of choline to trimethylamine (TMA) and its subsequent oxidation to trimethylamine N-oxide (TMAO) in the liver. What is unclear is whether choline and phosphatidylcholine in eggs is a source of TMAO formation, and if so how many eggs must be eaten before enough TMAO is generated to cause increased oxidized LDL (a biomarker for atherosclerosis mechanisms). We hypothesize that TMAO will only be formed from eggs when very large quantities are ingested and that TMAO formation will vary greatly between individuals for any given dietary exposure. This variability will be determined by 1) the dose at which dietary choline or phosphatidylcholine exceeds the absorptive capacity of the volunteer's small intestine and therefore spills into large intestine where gut bacteria have access to it and 2) the bacterial populations that constitute the volunteer's microbiome.
- Conditions
- Biomarkers of Cardiovascular Disease
- Being tested
- Egg Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg DoseOther
Different quantities of eggs
| Study group | Role | What they receive |
|---|---|---|
| Egg Dose | Experimental | Not described Receives: Other: Egg Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of TMAO
Measured: TMAO concentrations in plasma collected prior to and 1, 2, 6, 8, and 24 hours after egg ingestion.
Secondary outcomes (1)
Concentration of TMAO in urine
Measured: Concentration of TMAO will be measured in 24 hour urine collections that start the morning of the egg dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startOct 2012
- Primary completionJan 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biomarkers of Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- American Egg Board
- Responsible party
- Principal investigator, Steven Zeisel, University of North Carolina, Chapel Hill
- Investigators
- Steven H Zeisel, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906554
- Sponsor's protocol ID
- A12-1066-001
- Status last verified
- Jul 2013
- First submitted
- 16 Jul 2013
- Last updated
- 24 Jul 2013
- Results posted
- No
Publications
Miller CA, Corbin KD, da Costa KA, Zhang S, Zhao X, Galanko JA, Blevins T, Bennett BJ, O'Connor A, Zeisel SH. Effect of egg ingestion on trimethylamine-N-oxide production in humans: a randomized, controlled, dose-response study. Am J Clin Nutr. 2014 Sep;100(3):778-86. doi: 10.3945/ajcn.114.087692. Epub 2014 Jun 18.
PubMed 24944063
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Whether or Not Egg Ingestion Increases Concentrations of Trimethylamine N-oxide (TMAO) in Plasma and Urine and Activates LDL Oxidation in Humans
- ClinicalTrials.gov ID
- NCT01906554
- Acronym / sponsor ID
- A12-1066-001
- Conditions
- Biomarkers of Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- American Egg Board
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Jul 2013 (estimated)
- 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.
Eggs contain an essential nutrient called choline and adequate levels of choline are required for good health. Studies in mice have demonstrated that high levels of choline may increase risk of heart disease through a process that involves the breakdown of choline by gut bacteria. Previous research did not show that human consumption of eggs increases risk of heart disease. This study is designed to investigate whether the number of eggs in the diet affects blood and urine markers for heart disease.
Detailed description
Diets low in choline have adverse health consequences, while observations in humans and experiments in mouse models suggest that a diet containing too much choline or phosphatidylcholine may activate inflammatory pathways and increase cardiovascular disease risk through bacterial conversion of choline to trimethylamine (TMA) and its subsequent oxidation to trimethylamine N-oxide (TMAO) in the liver. What is unclear is whether choline and phosphatidylcholine in eggs is a source of TMAO formation, and if so how many eggs must be eaten before enough TMAO is generated to cause increased oxidized LDL (a biomarker for atherosclerosis mechanisms). We hypothesize that TMAO will only be formed from eggs when very large quantities are ingested and that TMAO formation will vary greatly between individuals for any given dietary exposure. This variability will be determined by 1) the dose at which dietary choline or phosphatidylcholine exceeds the absorptive capacity of the volunteer's small intestine and therefore spills into large intestine where gut bacteria have access to it and 2) the bacterial populations that constitute the volunteer's microbiome.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Egg Dose | Experimental | Other: Egg Dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy
- non-smoker
- Body mass index between 20 to 39 kg/m²
Key exclusion criteria (9 listed)
- History of chronic system disease/s (e.g., hepatic, renal, cardiovascular, intestinal)
- Diabetes controlled by insulin
- Alcohol or illegal drug misuse/abuse
- Use of antibiotics or choline-containing supplements within three months of study
- Allergies to soy, eggs, wheat or other food
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 DoseDifferent quantities of eggs | Other | Egg Dose |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of TMAO
Time frame: TMAO concentrations in plasma collected prior to and 1, 2, 6, 8, and 24 hours after egg ingestion.
1 secondary outcome
Concentration of TMAO in urine
Time frame: Concentration of TMAO will be measured in 24 hour urine collections that start the morning of the egg dose
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 24 Jul 2013.
- Derived from this study: PubMed 24944063Miller CA, Corbin KD, da Costa KA, Zhang S, Zhao X, Galanko JA, Blevins T, Bennett BJ, O'Connor A, Zeisel SH. Effect of egg ingestion on trimethylamine-N-oxide production in humans: a randomized, controlled, dose-response study. Am J Clin Nutr. 2014 Sep;100(3):778-86. doi: 10.3945/ajcn.114.087692. Epub 2014 Jun 18.
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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.
Steven H Zeisel, MD, PhD principal investigator
University of North Carolina, Chapel Hill
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 Dose in people with Biomarkers of Cardiovascular Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 3 inclusion and 9 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 24 Jul 2013. 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 United States. 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?
Area under the plasma concentration versus time curve (AUC) of TMAO (time frame: TMAO concentrations in plasma collected prior to and 1, 2, 6, 8, and 24 hours after egg ingestion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01906554, which also lists 1 linked publication.
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 24 Jul 2013.