Coronary Artery DiseaseNCT03877003
Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement.
A study testing Eggs in people with Coronary Artery Disease and Diabetes, run by University of Connecticut at 2 sites in United States.
Trial summary
The objective of this study is to determine the effects of consuming either 3 eggs per day and compare it to daily choline supplement (choline bitartrate) for a dose of approximately 400 mg/day on plasma concentrations of high density lipoprotein cholesterol (HDL-c), trimethylamine N oxide (TMAO) and plasma choline. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Diabetes, Metabolic Syndrome
- What is being tested?
- Eggs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2018to 30 Jun 2020
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All genders
- 35-70 years
- Metabolic syndrome (based on 3 out of 5 characteristics: waist circumference > 88 cm for women and > 102 cm for men, plasma triglycerides > 150 mg/dL, fasting glucose > 100 mg/dL, blood pressure > 135/85 and HDL < 40 mg/dL for men and < 50 mg/dL for women),
- willing to consume 3 eggs per day for 4 weeks
- willing to consume choline supplement (400 mg/day for 4 weeks)
Who cannot join
- Self-reported diaberes, cardiovascular disease, history of stroke, liver disease or cancer
- Taking glucose lowering medications
- Taking antibiotics in the previous 1 month
- Triglycerides > 500 mg/dL,
- Cholesterol > 240 mg/dL,
- blood pressure > 145/100 mm of Hg
- Allergic to eggs or to choline
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Department of Nutritional Sciences
Storrs, Connecticut, 06269
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement Intake
The objective of this study is to determine the effects of consuming either 3 eggs per day and compare it to daily choline supplement (choline bitartrate) for a dose of approximately 400 mg/day on plasma concentrations of high density lipoprotein cholesterol (HDL-c), trimethylamine N oxide (TMAO) and plasma choline. The goal is to determine if choline given as phosphatidyl choline (from eggs) will have a more beneficial effect on plasma choline and microbiota.
Read the detailed description
Epidemiological data suggests that egg intake does not increase the risk for cardiovascular disease (CVD). In fact eggs are a good source of phosphatidyl choline (PC) and choline has a number of metabolic roles including lipid metabolism, membrane structure, liver health and a neurotransmitter. Recent reports that choline may be metabolized by the intestinal microbiota into TMAO, a compound that may increase the risk for heart disease. It is not clear how much egg contribute to TMAO formation in individuals with metabolic syndrome.
Therefore the objective of this study is to determine the impact of daily intake of 3 eggs versus a choline supplement on plasma TMAO and other biomarkers for CVD risk and also to assess if there are changes in microbiota with these interventions that might lead to the increases of TMAO in plasma.
- Conditions
- Coronary Artery Disease, Diabetes, Metabolic Syndrome
- Being tested
- Eggs
- Keywords
- eggs,, choline, metabolic syndrome, TMAO
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EggsOther
Also called Dietary supplement (choline bitartrate)
Eggs: Consume 3 eggs per day for 4 weeks Choline supplement: Consume 1.5 pills per day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Egg Intake | Experimental | Consumption of 3 eggs per day for breakfast during 4 weeks Receives: Other: Eggs |
| Choline Supplement Intake | Experimental | Consumption of choline supplement 1.5 tablets (approx. 400 mg) with breakfast for 4 weeks Receives: Other: Eggs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma choline and TMAO (micromol/L)
They will be measured simultaneously by use of a mass spectrophotometer
Measured: 1 year
Plasma lipids (total cholesterol, HDL cholesterol and triglycerides) in mg/dL
They will be measured simultaneoulsy by use of an automated spectrophotometer
Measured: 1 year
Secondary outcomes (1)
Analysis of microbiota diversity (expressed as concentrations of different microorganisms.
All microorganisms are assayed simultaneously
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Nov 2018
- Primary completion14 Dec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover design
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- American Egg Board
- Responsible party
- Principal investigator, Maria Luz Fernandez, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877003
- Sponsor's protocol ID
- H18-126
- Status last verified
- Nov 2020
- First submitted
- 13 Mar 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement Intake
- ClinicalTrials.gov ID
- NCT03877003
- Acronym / sponsor ID
- H18-126
- Conditions
- Coronary Artery Disease, Diabetes, Metabolic Syndrome
- Keywords
- eggs,, choline, metabolic syndrome, TMAO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- American Egg Board
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 15 Mar 2019 (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 objective of this study is to determine the effects of consuming either 3 eggs per day and compare it to daily choline supplement (choline bitartrate) for a dose of approximately 400 mg/day on plasma concentrations of high density lipoprotein cholesterol (HDL-c), trimethylamine N oxide (TMAO) and plasma choline. The goal is to determine if choline given as phosphatidyl choline (from eggs) will have a more beneficial effect on plasma choline and microbiota.
Detailed description
Epidemiological data suggests that egg intake does not increase the risk for cardiovascular disease (CVD). In fact eggs are a good source of phosphatidyl choline (PC) and choline has a number of metabolic roles including lipid metabolism, membrane structure, liver health and a neurotransmitter. Recent reports that choline may be metabolized by the intestinal microbiota into TMAO, a compound that may increase the risk for heart disease. It is not clear how much egg contribute to TMAO formation in individuals with metabolic syndrome.
Therefore the objective of this study is to determine the impact of daily intake of 3 eggs versus a choline supplement on plasma TMAO and other biomarkers for CVD risk and also to assess if there are changes in microbiota with these interventions that might lead to the increases of TMAO in plasma.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover design
| Arm | Type | Receives |
|---|---|---|
| Egg Intake | Experimental | Other: EggsConsumption of 3 eggs per day for breakfast during 4 weeks |
| Choline Supplement Intake | Experimental | Other: EggsConsumption of choline supplement 1.5 tablets (approx. 400 mg) with breakfast for 4 weeks |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All genders
- 35-70 years
- Metabolic syndrome (based on 3 out of 5 characteristics: waist circumference > 88 cm for women and > 102 cm for men, plasma triglycerides > 150 mg/dL, fasting glucose > 100 mg/dL, blood pressure > 135/85 and HDL < 40 mg/dL for men and < 50 mg/dL for women),
- willing to consume 3 eggs per day for 4 weeks
- willing to consume choline supplement (400 mg/day for 4 weeks)
Key exclusion criteria (7 listed)
- Self-reported diaberes, cardiovascular disease, history of stroke, liver disease or cancer
- Taking glucose lowering medications
- Taking antibiotics in the previous 1 month
- Triglycerides > 500 mg/dL,
- Cholesterol > 240 mg/dL,
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 |
|---|---|---|
| EggsAlso: Dietary supplement (choline bitartrate)Eggs: Consume 3 eggs per day for 4 weeks Choline supplement: Consume 1.5 pills per day for 4 weeks | Other | Choline Supplement Intake, Egg Intake |
Primary outcome
Plasma choline and TMAO (micromol/L)
Time frame: 1 year
They will be measured simultaneously by use of a mass spectrophotometer
Plasma lipids (total cholesterol, HDL cholesterol and triglycerides) in mg/dL
Time frame: 1 year
They will be measured simultaneoulsy by use of an automated spectrophotometer
1 secondary outcome
Analysis of microbiota diversity (expressed as concentrations of different microorganisms.
Time frame: 1 year
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 3 Nov 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eggs in people with Coronary Artery Disease and Diabetes, run by University of Connecticut at 2 sites 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 5 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Plasma choline and TMAO (micromol/L) (time frame: 1 year). 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 3 Nov 2020.