Coronary Artery DiseaseNCT04234334
Benefits of Eggs in Combination With a Plant-based Diet
A study testing Consume 2 eggs with spinach per day and Egg Subsitute with spinach per day in people with Coronary Artery Disease and Diabetes, run by University of Connecticut at 1 site in United States.
Trial summary
The main objective of the study is to demonstrate that the inclusion of eggs to a plant-based diet will not increase the risk for heart disease but will increase the concentration of lutein and zeaxanthin, two important antioxidants and will also increase choline, an important component of membrane phospholipids. 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?
- Consume 2 eggs with spinach per day and Egg Subsitute with spinach per day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2020to 31 Aug 2022
- 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, blood pressure > 135/85 mm Hg, fasting glucose > 100 mg/dL and HDL < 40 mg/dL for men and < 50 mg/dL for women)
- Willing to consume a spinach omelet made with 2 eggs or the equivalent amount of egg substitute daily for 4 weeks each
- Willing to follow a plant-based diet for 13 weeks
- Not have cardiovascular disease, high cholesterol, diabetes, cancer, liver or renal disease
- Proficient in English
Who cannot join
- Self-reported diabetes, cardiovascular disease, history of stroke, liver disease or cancer
- Taking glucose lowering medications
- Triglycerides > 500 mg/dL
- Cholesterol > 240 mg/dL
- Blood pressure > 145/100 mm Hg
- Allergic to eggs or spinach
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Nutritional Sciences
Storrs, Connecticut, 06269
About this study
Official title: Evaluation of the Role of Eggs on Antioxidant Status, Plasma Choline and Lipoprotein Metabolism in Adults With Metabolic Syndrome Consuming a Plant-based Diet
The main objective of the study is to demonstrate that the inclusion of eggs to a plant-based diet will not increase the risk for heart disease but will increase the concentration of lutein and zeaxanthin, two important antioxidants and will also increase choline, an important component of membrane phospholipids.
Read the detailed description
Results from studies involving cells, animal models and clinical trials have demonstrated that lutein and zeaxanthin potentially protect against chronic diseases, including age-related macular degeneration, cataracts, coronary heart disease and stroke. Plasma concentrations of lutein and zeaxanthin are closely associated with their antioxidant properties and with their protection against reactive oxygen species (ROS).
Choline is recognized as an essential nutrient for health because of its many functions in growth and development, as well as neurological function and formation of membrane phospholipids, including phosphatidylcholine (PC) and sphingomyelin.
Therefore the objective of this study is to demonstrate that inclusion of eggs in a plant-based diet will potentiate the benefits of this healthy diet by increasing plasma concentrations of lutein, zexanthin and choline presents in egg yolks and theoretically increase the antioxidant and anti-inflammatory actions of these components. This would be potentially more important in those individuals with metabolic syndrome, which is the target population of this intervention.
- Conditions
- Coronary Artery Disease, Diabetes, Metabolic Syndrome
- Being tested
- Consume 2 eggs with spinach per day, Egg Subsitute with spinach per day
- Keywords
- eggs, lutein, zeaxanthin, choline, metabolic syndrome, plant-based diet
- 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.
Consume 2 eggs with spinach per dayOther
Also called Egg substitute
Participants will be randomly allocated to consume either 2 eggs or 2 egg substitutes with spinach daily for 4 weeks and after a 3-week wash out, they will be allocated to the alternate treatment
Egg Subsitute with spinach per dayOther
Egg Subsitute with spinach per day
| Study group | Role | What they receive |
|---|---|---|
| Egg intake | Experimental | Consumption of 2 eggs with spinach daily for breakfast for 4 weeks Receives: Other: Consume 2 eggs with spinach per day |
| Egg Subsitute | Experimental | Consumption of 2 egg substitutes daily for breakfast for 4 weeks Receives: Other: Egg Subsitute with spinach per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma lutein
Plasma lutien will be measured by HPLC. The units are expresses as µmol/L
Measured: 1 year
Plasma choline
It will be measured by mass spectometry. The units are expressed as nmol/mL
Measured: 1 year
Plasma Zeaxanthin
Plasma zeaxanthin will by measured by HPLC. The units are expressed as µmol/L
Measured: 1 year
Secondary outcomes (2)
Plasma lipids
Total, LDL and HDL cholesterol and triglycerides will be measured by an automated spectrometer simultaneously. The units are expressed as mg/dL
Measured: 1 year
Plasma glucose
Plasma glucose will be measured by an automated spectrometer. Units are expressed as mg/dL
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 posted21 Jan 2020
- Study start13 Jan 2020
- Primary completion31 Mar 2022
- Study completion31 Aug 2022
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 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
- Investigators
- Maria-Luz Fernandez, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234334
- Sponsor's protocol ID
- H19-178
- Status last verified
- Nov 2022
- First submitted
- 13 Jan 2020
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Eggs on Antioxidant Status, Plasma Choline and Lipoprotein Metabolism in Adults With Metabolic Syndrome Consuming a Plant-based Diet
- ClinicalTrials.gov ID
- NCT04234334
- Acronym / sponsor ID
- H19-178
- Conditions
- Coronary Artery Disease, Diabetes, Metabolic Syndrome
- Keywords
- eggs, lutein, zeaxanthin, choline, metabolic syndrome, plant-based diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- American Egg Board
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 21 Jan 2020 (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 main objective of the study is to demonstrate that the inclusion of eggs to a plant-based diet will not increase the risk for heart disease but will increase the concentration of lutein and zeaxanthin, two important antioxidants and will also increase choline, an important component of membrane phospholipids.
Detailed description
Results from studies involving cells, animal models and clinical trials have demonstrated that lutein and zeaxanthin potentially protect against chronic diseases, including age-related macular degeneration, cataracts, coronary heart disease and stroke. Plasma concentrations of lutein and zeaxanthin are closely associated with their antioxidant properties and with their protection against reactive oxygen species (ROS).
Choline is recognized as an essential nutrient for health because of its many functions in growth and development, as well as neurological function and formation of membrane phospholipids, including phosphatidylcholine (PC) and sphingomyelin.
Therefore the objective of this study is to demonstrate that inclusion of eggs in a plant-based diet will potentiate the benefits of this healthy diet by increasing plasma concentrations of lutein, zexanthin and choline presents in egg yolks and theoretically increase the antioxidant and anti-inflammatory actions of these components. This would be potentially more important in those individuals with metabolic syndrome, which is the target population of this intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Crossover design
| Arm | Type | Receives |
|---|---|---|
| Egg intake | Experimental | Other: Consume 2 eggs with spinach per dayConsumption of 2 eggs with spinach daily for breakfast for 4 weeks |
| Egg Subsitute | Experimental | Other: Egg Subsitute with spinach per dayConsumption of 2 egg substitutes daily for 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 (7 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, blood pressure > 135/85 mm Hg, fasting glucose > 100 mg/dL and HDL < 40 mg/dL for men and < 50 mg/dL for women)
- Willing to consume a spinach omelet made with 2 eggs or the equivalent amount of egg substitute daily for 4 weeks each
- Willing to follow a plant-based diet for 13 weeks
Key exclusion criteria (6 listed)
- Self-reported diabetes, cardiovascular disease, history of stroke, liver disease or cancer
- Taking glucose lowering medications
- Triglycerides > 500 mg/dL
- Cholesterol > 240 mg/dL
- Blood pressure > 145/100 mm Hg
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 |
|---|---|---|
| Consume 2 eggs with spinach per dayAlso: Egg substituteParticipants will be randomly allocated to consume either 2 eggs or 2 egg substitutes with spinach daily for 4 weeks and after a 3-week wash out, they will be allocated to the alternate treatment | Other | Egg intake |
| Egg Subsitute with spinach per dayEgg Subsitute with spinach per day | Other | Egg Subsitute |
Primary outcome
Plasma lutein
Time frame: 1 year
Plasma lutien will be measured by HPLC. The units are expresses as µmol/L
Plasma choline
Time frame: 1 year
It will be measured by mass spectometry. The units are expressed as nmol/mL
Plasma Zeaxanthin
Time frame: 1 year
Plasma zeaxanthin will by measured by HPLC. The units are expressed as µmol/L
2 secondary outcomes
Plasma lipids
Time frame: 1 year
Plasma glucose
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 2022.
- 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.
Maria-Luz Fernandez, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consume 2 eggs with spinach per day and Egg Subsitute with spinach per day in people with Coronary Artery Disease and Diabetes, run by University of Connecticut 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 7 inclusion and 6 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 2022. 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?
Plasma lutein (time frame: 1 year). The study lists 3 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 2022.