Cardiovascular DiseasesNCT02297464
Eggs as Part of a Healthy Breakfast
A study testing Eggs - 2 per day for breakfast and 1 packet of oatmeal per day in people with Cardiovascular Diseases, run by University of Connecticut at 1 site in United States.
Trial summary
Contrary to popular belief, previous studies have demonstrated beneficial effects of whole egg consumption in modifying biomarkers indicative of a greater risk of coronary heart disease (CHD), chronic inflammation, and insulin resistance. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Eggs - 2 per day for breakfast and 1 packet of oatmeal per day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Mar 2018
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18.5-30, willing to consume eggs and oatmeal daily, proficient in English, and with a healthy lipid profile.
Who cannot join
- Currently have liver disease, renal disease, diabetes, cancer, history of stroke or heart disease
- Currently taking glucose lowering drugs or supplements
- Plasma triglycerides >500 mg/dL, glucose >126, total cholesterol >240
- Pregnant, lactating, or have endocrine or metabolic disorders
- BMI ≥ 30
- Blood pressure > 140/90 (average of 3 readings)
- Allergies to eggs
- Celiac disease or gluten sensitivity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: Eggs as Part of a Healthy Breakfast: Lack of Association With Heart Disease Risk
Contrary to popular belief, previous studies have demonstrated beneficial effects of whole egg consumption in modifying biomarkers indicative of a greater risk of coronary heart disease (CHD), chronic inflammation, and insulin resistance. The following study is designed to conduct a comprehensive evaluation of consuming an egg-based breakfast compared to an oatmeal-based breakfast on lipid biomarkers, oxidative stress, inflammation, insulin sensitivity, and satiety in young, healthy men and women. The investigators hypothesize that the consumption of 2 eggs per day will not negatively impact plasma lipids in a young, healthy population.
- Conditions
- Cardiovascular Diseases
- Being tested
- Eggs - 2 per day for breakfast, 1 packet of oatmeal per day
- Keywords
- Risk
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eggs - 2 per day for breakfastOther
11-week crossover study in which participants consumed 2 eggs or 1 packet of oatmeal per day daily for 4 weeks, separated by a 3-week washout period.
1 packet of oatmeal per dayOther
11-week crossover study in which participants consumed 2 eggs or 1 packet of oatmeal per day daily for 4 weeks, separated by a 3-week washout period.
| Study group | Role | What they receive |
|---|---|---|
| Eggs - 2 per day for breakfast | Experimental | Participants will consume 2 eggs per day for breakfast for 4 weeks of the study. Receives: Other: Eggs - 2 per day for breakfast; Other: 1 packet of oatmeal per day |
| Oatmeal - 1 packet per day for breakfast | Experimental | Participants will consume 1 packet of oatmeal per day for breakfast for 4 weeks of the study. Receives: Other: Eggs - 2 per day for breakfast; Other: 1 packet of oatmeal per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectrophotometry, NMR and ELISA will assess plasma lipids.
Measured: 1 year
Secondary outcomes (1)
Visual analog scales (VAS) and ELISA assays will assess satiety.
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 Nov 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Luz Fernandez, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297464
- Sponsor's protocol ID
- H14-032
- Status last verified
- Mar 2018
- First submitted
- 13 Nov 2014
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eggs as Part of a Healthy Breakfast: Lack of Association With Heart Disease Risk
- ClinicalTrials.gov ID
- NCT02297464
- Acronym / sponsor ID
- H14-032
- Conditions
- Cardiovascular Diseases
- Keywords
- Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 21 Nov 2014 (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.
Contrary to popular belief, previous studies have demonstrated beneficial effects of whole egg consumption in modifying biomarkers indicative of a greater risk of coronary heart disease (CHD), chronic inflammation, and insulin resistance. The following study is designed to conduct a comprehensive evaluation of consuming an egg-based breakfast compared to an oatmeal-based breakfast on lipid biomarkers, oxidative stress, inflammation, insulin sensitivity, and satiety in young, healthy men and women. The investigators hypothesize that the consumption of 2 eggs per day will not negatively impact plasma lipids in a young, healthy population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eggs - 2 per day for breakfast | Experimental | Other: Eggs - 2 per day for breakfast, Other: 1 packet of oatmeal per dayParticipants will consume 2 eggs per day for breakfast for 4 weeks of the study. |
| Oatmeal - 1 packet per day for breakfast | Experimental | Other: Eggs - 2 per day for breakfast, Other: 1 packet of oatmeal per dayParticipants will consume 1 packet of oatmeal per day for breakfast for 4 weeks of the study. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 18.5-30, willing to consume eggs and oatmeal daily, proficient in English, and with a healthy lipid profile.
Key exclusion criteria (8 listed)
- Currently have liver disease, renal disease, diabetes, cancer, history of stroke or heart disease
- Currently taking glucose lowering drugs or supplements
- Plasma triglycerides >500 mg/dL, glucose >126, total cholesterol >240
- Pregnant, lactating, or have endocrine or metabolic disorders
- BMI ≥ 30
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 |
|---|---|---|
| Eggs - 2 per day for breakfast11-week crossover study in which participants consumed 2 eggs or 1 packet of oatmeal per day daily for 4 weeks, separated by a 3-week washout period. | Other | Eggs - 2 per day for breakfast, Oatmeal - 1 packet per day for breakfast |
| 1 packet of oatmeal per day11-week crossover study in which participants consumed 2 eggs or 1 packet of oatmeal per day daily for 4 weeks, separated by a 3-week washout period. | Other | Eggs - 2 per day for breakfast, Oatmeal - 1 packet per day for breakfast |
Primary outcome
Spectrophotometry, NMR and ELISA will assess plasma lipids.
Time frame: 1 year
1 secondary outcome
Visual analog scales (VAS) and ELISA assays will assess satiety.
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 22 Mar 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eggs - 2 per day for breakfast and 1 packet of oatmeal per day in people with Cardiovascular Diseases, 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 1 inclusion and 8 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 22 Mar 2018. 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?
Spectrophotometry, NMR and ELISA will assess plasma lipids. (time frame: 1 year). 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 22 Mar 2018.