Lipid MetabolismNCT03577223
Egg Effects on the Immunomodulatory Properties of HDL
A study testing Whole Eggs and Egg White-Based Egg Substitute in people with Lipid Metabolism and Inflammation, run by Fairfield University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of egg intake on markers of HDL function and immune inflammation in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism, Inflammation
- What is being tested?
- Whole Eggs and Egg White-Based Egg Substitute
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2018to 15 May 2019
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years old
- Body mass index (BMI) < 30 kg/m2, or < 30% body fat for men and < 40% body fat for women
- Willingness to consume eggs or egg whites on a daily basis during study periods
Who cannot join
- < 18 years old; > 35 years old
- BMI ≥ 30 kg/m2, or ≥ 30% body fat for men and ≥ 40% body fat for women
- Self-reported history of diabetes mellitus, coronary heart disease, stroke, renal problems, liver disease, cancer, pregnancy or lactation, autoimmunity, chronic infections, or egg allergy
- Taking lipid-lowering medications (e.g. statins, fibrates)
- A preexisting medical condition or implanted medical device that prevents participation in bioelectrical impedance measurements of body composition
- Clinical lipid and glucose values that are highly elevated, including fasting triglycerides levels higher than 500 mg/dL, fasting glucose higher than 126 mg/dL, and plasma total cholesterol greater than 240 mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effects of egg intake on markers of HDL function and immune inflammation in healthy adults.
Read the detailed description
28 healthy men and women (age 18-35 years old) will be recruited to participate in a 16-week randomized crossover study. Upon enrollment, all subjects will enter a 4-week run-in egg-free period where they will refrain from consuming any egg-based foods (Period 1). Subjects will then enter the first intervention period, where they be randomly assigned to consume either 3 whole eggs/day or the equivalent amount of egg white-based egg substitute/day for 4 weeks (Period 2). Afterwards, subjects will enter a 4-week washout period where egg-based foods are restricted (Period 3), followed by a second intervention period, where they be assigned to the alternative whole egg- or egg white-based treatment for 4 weeks (Period 4). Subjects will come to the Department of Biology at Fairfield University every two weeks to check-in, and to pick up their egg products during the intervention periods. Subjects will be asked to maintain their normal diet and physical activity practices throughout all periods of the study. Subjects will complete 5-day dietary records and physical activity logs at the end of each study period.
- Conditions
- Lipid Metabolism, Inflammation
- Being tested
- Whole Eggs, Egg White-Based Egg Substitute
- Keywords
- Egg, HDL, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole EggsOther
3 whole eggs per day for 4 weeks
Egg White-Based Egg SubstituteOther
3-egg equivalent of egg white-based egg substitute per day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Whole Eggs | Experimental | Not described Receives: Other: Whole Eggs |
| Egg White-Based Egg Substitute | Active comparator | Not described Receives: Other: Egg White-Based Egg Substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasted HDL-cholesterol
Measurement of fasted plasma HDL-cholesterol levels (mg/dL) at the end of the run-in period, and two intervention arms.
Measured: 16 weeks
Secondary outcomes (3)
Fasted HDL lipid composition
HDL subfractions (d = 1.063-1.21) will be isolated from plasma by ultracentrifugation collected at the end of the run-in period and two intervention arms. HDL fractions will be analyzed for glycerphospholipid (phosphatidylcholine, phosphatidylethanolamine, lysophosphatidylcholine, phosphatidylinositol) and sphingolipid (sphingomyelin) composition by mass spectrometry. Each lipid class will be presented as a percent (%) of total HDL lipids.
Measured: 16 weeks
Cholesterol-accepting capacity of serum
The cholesterol efflux from macrophages to subject serum will be measured at the end of the egg-free run-in period and both intervention periods using a fluorescent cholesterol efflux kit. Results will be expressed as % cholesterol efflux, calculated as (fluorescence intensity of media/[fluorescent intensity of cell lysates + media]) x 100.
Measured: 16 weeks
Inflammatory potential of peripheral blood mononuclear cells
Peripheral blood mononuclear cells (PBMCs) will be isolated at the end of the egg-free run-in period and both intervention periods. PBMCs will be cultured ex vivo and stimulated with lipopolysaccharide. Media will be collected to measure tumor necrosis factor alpha concentrations (pg/mL) in cell media.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start7 Sep 2018
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid MetabolismStudies 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
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fairfield University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Catherine Andersen, Fairfield University
- Investigators
- Catherine J Andersen, PhD, RD, Principal investigator, Fairfield University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577223
- Sponsor's protocol ID
- 0511
- Status last verified
- May 2021
- First submitted
- 15 Jun 2018
- Last updated
- 28 May 2021
- Results posted
- 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 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Egg Effects on the Immunomodulatory Properties of HDL
- ClinicalTrials.gov ID
- NCT03577223
- Acronym / sponsor ID
- 0511
- Conditions
- Lipid Metabolism, Inflammation
- Keywords
- Egg, HDL, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Fairfield UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 5 Jul 2018 (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 study is to investigate the effects of egg intake on markers of HDL function and immune inflammation in healthy adults.
Detailed description
28 healthy men and women (age 18-35 years old) will be recruited to participate in a 16-week randomized crossover study. Upon enrollment, all subjects will enter a 4-week run-in egg-free period where they will refrain from consuming any egg-based foods (Period 1). Subjects will then enter the first intervention period, where they be randomly assigned to consume either 3 whole eggs/day or the equivalent amount of egg white-based egg substitute/day for 4 weeks (Period 2). Afterwards, subjects will enter a 4-week washout period where egg-based foods are restricted (Period 3), followed by a second intervention period, where they be assigned to the alternative whole egg- or egg white-based treatment for 4 weeks (Period 4). Subjects will come to the Department of Biology at Fairfield University every two weeks to check-in, and to pick up their egg products during the intervention periods. Subjects will be asked to maintain their normal diet and physical activity practices throughout all periods of the study. Subjects will complete 5-day dietary records and physical activity logs at the end of each study period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Eggs | Experimental | Other: Whole Eggs |
| Egg White-Based Egg Substitute | Active comparator | Other: Egg White-Based Egg Substitute |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-35 years old
- Body mass index (BMI) < 30 kg/m2, or < 30% body fat for men and < 40% body fat for women
- Willingness to consume eggs or egg whites on a daily basis during study periods
Key exclusion criteria (6 listed)
- < 18 years old; > 35 years old
- BMI ≥ 30 kg/m2, or ≥ 30% body fat for men and ≥ 40% body fat for women
- Self-reported history of diabetes mellitus, coronary heart disease, stroke, renal problems, liver disease, cancer, pregnancy or lactation, autoimmunity, chronic infections, or egg allergy
- Taking lipid-lowering medications (e.g. statins, fibrates)
- A preexisting medical condition or implanted medical device that prevents participation in bioelectrical impedance measurements of body composition
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 |
|---|---|---|
| Whole Eggs3 whole eggs per day for 4 weeks | Other | Whole Eggs |
| Egg White-Based Egg Substitute3-egg equivalent of egg white-based egg substitute per day for 4 weeks | Other | Egg White-Based Egg Substitute |
Primary outcome
Fasted HDL-cholesterol
Time frame: 16 weeks
Measurement of fasted plasma HDL-cholesterol levels (mg/dL) at the end of the run-in period, and two intervention arms.
3 secondary outcomes
Fasted HDL lipid composition
Time frame: 16 weeks
Cholesterol-accepting capacity of serum
Time frame: 16 weeks
Inflammatory potential of peripheral blood mononuclear cells
Time frame: 16 weeks
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 May 2021.
- 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.
Catherine J Andersen, PhD, RD principal investigator
Fairfield 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 Whole Eggs and Egg White-Based Egg Substitute in people with Lipid Metabolism and Inflammation, run by Fairfield University 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 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 28 May 2021. 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?
Fasted HDL-cholesterol (time frame: 16 weeks). 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 May 2021.