HyperlipidemiasNCT05807334
Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern in Hyperlipidemic Adults
A study testing DASH eating plan with eggs and DASH eating plan without eggs in people with Hyperlipidemias, run by Griffin Hospital at 1 site in United States.
Trial summary
This randomized, cross-over design, controlled trial will assess the effects of 8 weeks of daily inclusion of 2 whole eggs in the Dietary Approaches to Stop Hypertension (DASH) eating plan, compared with their exclusion, on cardio-metabolic risk markers and diet quality in hyperlipidemic adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- DASH eating plan with eggs and DASH eating plan without eggs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2023to Jul 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men >18 years of age
- Post-menopausal women not currently on hormone replacement therapy
- Non-smokers
- Overweight/obese (i.e., 25kg/m² ≤ BMI ≤ 40kg/m² and weight <350pounds)
- Total cholesterol of 240-300 mg/dl and /or LDL cholesterol of 130-190 mg/dl, and/or a total cholesterol to HDL ratio of >5.7
Who cannot join
- Failure to meet inclusion criteria
- Anticipated inability to complete study protocol for any reason
- Allergy to eggs
- Current eating disorder
- Restricted diets by choice that do not permit ingestion of eggs (e.g., vegan)
- Unstable use of lipid-lowering or antihypertensive medications (i.e., change in dose during the three months prior to enrollment) and/or unwilling to refrain from taking medication for 12 hours prior to endothelial function scanning
Show all 17Show fewer
- Use of insulin, glucose-sensitizing medication, or vasoactive medication (including glucocorticoids, antineoplastic agents, some psychoactive agents, or bronchodilators)
- Unstable use of antidepressant medications (i.e., change in dose during the three months prior to enrollment)
- Regular use of high doses of vitamin E (>400IU/day) or vitamin C (>500mg/day); fish oil, flaxseed oil, omega-3 fatty acid and/or fiber supplements, unless willing to discontinue supplementation for the study duration
- Diagnosed diabetes
- Diagnosed sleep apnea; unless treated and have been stable with their medications for at least 3 months
- Established cardiovascular disease (including symptomatic coronary artery disease (CAD), myocardial infarction, peripheral vascular disease, congestive heart failure, carotid stenosis)
- Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; current use of warfarin or other regular use of anticoagulation
- Substance abuse (chronic alcoholism, other chemical dependency)
- Any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, AIDS, tuberculosis, psychotic disorder)
- Conditions requiring regular use of NSAID medications such as Advil, naproxen, ibuprofen (examples of condition include lupus and rheumatoid arthritis)
- For women: Use of hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Yale-Griffin Prevention Research Center
Derby, Connecticut, 06418
Rockiy G. Ayettey, MS, 203-732-1125, rockiy.ayettey@yalegriffinprc.org
Valentine Y. Njike, MD,MPH
About this study
Official title: Effects of Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern on Cardio-Metabolic Risk Factors and Diet Quality in Hyperlipidemic Adults
This randomized, cross-over design, controlled trial will assess the effects of 8 weeks of daily inclusion of 2 whole eggs in the Dietary Approaches to Stop Hypertension (DASH) eating plan, compared with their exclusion, on cardio-metabolic risk markers and diet quality in hyperlipidemic adults.
Read the detailed description
This randomized, cross-over design, controlled trial will assess the effects of 8 weeks of daily inclusion of 2 whole eggs in the Dietary Approaches to Stop Hypertension (DASH) eating plan, compared with their exclusion, on cardio-metabolic risk markers, and diet quality in hyperlipidemic adults. Participants will be randomized to receive 1 of 2 treatment sequence permutations (i.e., DASH eating plan with eggs and DASH eating plan without eggs), with an 8-week washout period between treatment assignments. After randomization, participants will undergo a 4-week run-in period of a DASH eating plan without egg products before initiating the first of 2 treatment phases in their randomly-assigned sequence permutation.
Specific Aims
- To assess the effects of the inclusion of 2 whole eggs/day for 8 weeks in a DASH eating plan, as compared with their exclusion, on endothelial function measured as flow-mediated dilatation and on LDL cholesterol in hyperlipidemic adults.
- To determine the effects of the inclusion of 2 whole eggs/day in the context of a DASH eating plan, as compared with their exclusion, on cardio-metabolic risk factors and diet quality in adults with hyperlipidemia over a period of 8 weeks.
- Conditions
- Hyperlipidemias
- Being tested
- DASH eating plan with eggs, DASH eating plan without eggs
- Keywords
- Hyperlipidemia, Cardio-metabolic, Endothelial function
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH eating plan with eggsOther
Participants will receive guidance to follow a DASH dietary pattern tailored to their caloric requirements and their personal and cultural food preferences, along with sample meal plans and other supplemental educational materials to help them adopt and maintain the dietary pattern during this study. During this 8-week phase, they will also be instructed to eat 2 whole eggs per day to supplement the DASH eating pattern.
DASH eating plan without eggsOther
Participants will receive guidance to follow a DASH dietary pattern tailored to their caloric requirements and their personal and cultural food preferences, along with sample meal plans and other supplemental educational materials to help them adopt and maintain the dietary pattern during this study. During this 8-week phase, they will also be instructed to exclude eggs from their diet on a daily basis.
| Study group | Role | What they receive |
|---|---|---|
| DASH eating plan with eggs | Experimental | Participants will receive dietary guidance to follow the DASH eating plan with the addition of 2 whole eggs daily during this 8-week treatment period. Receives: Other: DASH eating plan with eggs |
| DASH eating plan without eggs | Active comparator | Participants will receive dietary guidance to follow the DASH eating plan while excluding eggs from their eating plan during this 8-week treatment period. Receives: Other: DASH eating plan without eggs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function, % flow-mediated dilatation
Endothelial function measured as percent flow-mediated dilatation in the right brachial artery.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Serum LDL cholesterol, mg/dL
Serum low-density lipoprotein (LDL) will be calculated using the formula LDL = Tchol - (TG/5 + HDL). See below for secondary outcome measures of total cholesterol (Tchol), high-density lipoprotein (HDL) and triglycerides (TG).
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Secondary outcomes (20)
High sensitivity C-reactive protein (CRP), mg/dL
CRP will be measured from the serum using a high sensitivity CRP ELISA method, from blood samples collected at each visit by a certified phlebotomist in the Griffin Hospital laboratory.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Total cholesterol (Tchol), mg/dL
Tchol values will be directly measured from participants' serum from blood samples collected at each visit by a certified phlebotomist in the Griffin Hospital laboratory.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Triglycerides (TG), mg/dL
TG values will be directly measured from participants' serum from blood samples collected at each visit by a certified phlebotomist in the Griffin Hospital laboratory.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
High-density lipoprotein (HDL), mg/dL
HDL values will be directly measured from participants' serum from blood samples collected at each visit by a certified phlebotomist in the Griffin Hospital laboratory.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Total/HDL cholesterol ratio
The total/HDL cholesterol ratio is calculated by dividing the total cholesterol level in mg/dL by the HDL cholesterol level in mg/dL.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Systolic blood pressure (SBP), mm Hg
Systolic blood pressure will be measured using a Dinamap Monitor Pro 100 (GE Healthcare, Piscataway, NJ). It will be measured (average of 2 measurements with 5 minutes between measurements) with the participant sitting in a quiet room.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Diastolic blood pressure (DBP), mm Hg
Diastolic BP will be measured using a Dinamap Monitor Pro 100 (GE Healthcare, Piscataway, NJ). It will be measured (average of 2 measurements with 5 minutes between measurements) with the participant sitting in a quiet room.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Mean arterial blood pressure, mm Hg
Mean arterial blood pressure is calculated as ( 2*DBP + SBP)/3
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Fasting blood glucose, mg/dL
Glucose levels will be measured from serum of blood samples collected at each visit by a certified phlebotomist in the Griffin Hospital laboratory. Participants will be asked to fast at least 8 hours prior to blood sample collection.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Fasting insulin, mIU/L
Insulin levels will be measured from serum of blood samples collected at each visit by a certified phlebotomist in the Griffin Hospital laboratory. Participants will be asked to fast at least 8 hours prior to blood sample collection.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Insulin resistance (HOMA-IR) will be calculated by multiplying the participant's glucose (mg/dL) and insulin (mIU/L) divided by 405.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Satiety, measured on a Visual Analogue Scale (VAS)
At the end of each 8-week treatment period, following an 8-hour fast, subjective satiety will be assessed using an ordinal Visual Analogue Scale (VAS) self-administered to participants by the study coordinator at a predetermined time relative to the consumption of a meal or snack. Participants will be asked to complete the VAS at 0 minute, and at 30-minute intervals up to 120 minutes after consuming the meal or snack. The VAS has 5 questions that ask participants to rate the strength of specific sensations that they are feeling (i.e., hunger, thirst, amount of food that they could eat "right now", nausea, and fullness) by placing a vertical mark on a corresponding scale in response to each question. A composite score from each of the 5 scales will then be used by the study coordinator to estimate a total value for satiety.
Measured: At the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Body weight, kilograms
Body weight will be measured by a clinical research specialist to the nearest 0.5 kilogram using a balance-type medical scale. Participants will be measured in the morning (fasting), unclothed except for undergarments.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Body mass index (BMI) (weight in kg/height in meters squared)
The Tanita SC-240 Body Composition Analyzer (Tokyo, Japan) will be used by a clinical research specialist in the PRC lab by asking the participant to stand on the scale. Weight will be measured using the SC-240 Analyzer. Height will be measured on a balance scale and will be manually entered into the Tanita Analyzer, which will be combined with the weight measure to calculate BMI.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Body fat, %
The Tanita SC-240 Body Composition Analyzer (Tokyo, Japan) will be used by a clinical research specialist in the PRC lab by asking the participant to stand on the scale. The SC-240 Analyzer uses bioelectrical impedance analysis to calculate body fat%.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Body water, %
The Tanita SC-240 Body Composition Analyzer (Tokyo, Japan) will be used by a clinical research specialist in the PRC lab by asking the participant to stand on the scale. The SC-240 Analyzer uses bioelectrical impedance analysis to calculate total body water%.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Visceral fat rating
The Tanita SC-240 Body Composition Analyzer (Tokyo, Japan) will be used by a clinical research specialist in the PRC lab by asking the participant to stand on the scale. The SC-240 Analyzer uses bioelectrical impedance analysis to calculate a rating for visceral fat located deep in the core abdominal area. A rating in the range of 1 to 12 indicates a healthy level of visceral fat. A rating in the range of 13 to 59 indicates an excess level of visceral fat.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Waist circumference, cm
Waist circumference will be measured using the U.S. government standard protocol. A clinical research specialist will ask the participant to stand and will place a measurement tape around the participant's waist, at the level of the belly button. The clinical research specialist will ensure that the tape is horizontal around the participant's waist, and will then keep the tape snug around the participant's waist while not compressing the skin, and will measure her/his waist just after exhaling.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Diet quality, using the Healthy Eating Index 2015 (HEI-2015)
To track any variation in dietary pattern over the course of the study, participants will be asked to provide information on the foods and beverages consumed during a 3-day period (i.e., 2 weekdays and 1 weekend day). For each 3-day period, participants will complete three 24-hour recalls using a web-based Automated Self-Administered 24-Hour Recall (ASA24), a dietary assessment software program that will guide them through the process of completing the recall data; these data (which will be captured and stored within the ASA24 program's database) will be reviewed by a member of the study team. Diet quality based on the information provided will be assessed using the Healthy Eating Index 2015 (HEI-2015), which will generate a scale ranging from 1-100, with a higher value indicating a relatively better overall quality of the diet.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Physical activity level (PA), kilocalories
Participants' PA levels will be assessed by the study coordinator using the Seven-Day Physical Activity Recall questionnaire (PAR) in the course of a semi-structured interview. The PAR is a valid and reliable tool to estimate the total amount of kilocalories expended on physical activity in adults during the past week. It asks participants to report the amount of time spent in the past week on household and yard-work activities, occupational activity, transport, leisure time physical activity and sedentary behavior. The type, duration in hours, and level of intensity of reported physical activities are then used to estimate the total amount of kilocalories expended on PA during the past week.
Measured: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start7 Mar 2023
- Primary completionApr 2024 (estimated)
- Study completionJul 2024 (estimated)
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 HyperlipidemiasStudies 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, controlled trial
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Griffin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Egg Nutrition Center
- Responsible party
- Sponsor
- Investigators
- Valentine Y. Njike, MD, MPH, Principal investigator, Griffin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807334
- Sponsor's protocol ID
- 2023-001
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Njike VY, Ayettey RG, Foster JS, Comerford BP, Multany S, Gill AS. Effect of Daily Incorporation of Eggs in a Heart-Healthy Diet for 8 Weeks Compared with Their Exclusion on Cardio-Metabolic Risk Factors in Adults with Hyperlipidemia: A Randomized, Controlled, Crossover Trial. J Am Nutr Assoc. 2026 Mar-Apr;45(3):237-249. doi: 10.1080/27697061.2025.2560431. Epub 2025 Sep 16.
PubMed 40957619
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern on Cardio-Metabolic Risk Factors and Diet Quality in Hyperlipidemic Adults
- ClinicalTrials.gov ID
- NCT05807334
- Acronym / sponsor ID
- 2023-001
- Conditions
- Hyperlipidemias
- Keywords
- Hyperlipidemia, Cardio-metabolic, Endothelial function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Griffin HospitalUniversity, hospital or other
- Collaborators
- Egg Nutrition Center
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 11 Apr 2023 (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.
This randomized, cross-over design, controlled trial will assess the effects of 8 weeks of daily inclusion of 2 whole eggs in the Dietary Approaches to Stop Hypertension (DASH) eating plan, compared with their exclusion, on cardio-metabolic risk markers and diet quality in hyperlipidemic adults.
Detailed description
This randomized, cross-over design, controlled trial will assess the effects of 8 weeks of daily inclusion of 2 whole eggs in the Dietary Approaches to Stop Hypertension (DASH) eating plan, compared with their exclusion, on cardio-metabolic risk markers, and diet quality in hyperlipidemic adults. Participants will be randomized to receive 1 of 2 treatment sequence permutations (i.e., DASH eating plan with eggs and DASH eating plan without eggs), with an 8-week washout period between treatment assignments. After randomization, participants will undergo a 4-week run-in period of a DASH eating plan without egg products before initiating the first of 2 treatment phases in their randomly-assigned sequence permutation.
Specific Aims
- To assess the effects of the inclusion of 2 whole eggs/day for 8 weeks in a DASH eating plan, as compared with their exclusion, on endothelial function measured as flow-mediated dilatation and on LDL cholesterol in hyperlipidemic adults.
- To determine the effects of the inclusion of 2 whole eggs/day in the context of a DASH eating plan, as compared with their exclusion, on cardio-metabolic risk factors and diet quality in adults with hyperlipidemia over a period of 8 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, crossover design, controlled trial
| Arm | Type | Receives |
|---|---|---|
| DASH eating plan with eggs | Experimental | Other: DASH eating plan with eggsParticipants will receive dietary guidance to follow the DASH eating plan with the addition of 2 whole eggs daily during this 8-week treatment period. |
| DASH eating plan without eggs | Active comparator | Other: DASH eating plan without eggsParticipants will receive dietary guidance to follow the DASH eating plan while excluding eggs from their eating plan during this 8-week treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men >18 years of age
- Post-menopausal women not currently on hormone replacement therapy
- Non-smokers
- Overweight/obese (i.e., 25kg/m² ≤ BMI ≤ 40kg/m² and weight <350pounds)
- Total cholesterol of 240-300 mg/dl and /or LDL cholesterol of 130-190 mg/dl, and/or a total cholesterol to HDL ratio of >5.7
Key exclusion criteria (17 listed)
- Failure to meet inclusion criteria
- Anticipated inability to complete study protocol for any reason
- Allergy to eggs
- Current eating disorder
- Restricted diets by choice that do not permit ingestion of eggs (e.g., vegan)
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 |
|---|---|---|
| DASH eating plan with eggsParticipants will receive guidance to follow a DASH dietary pattern tailored to their caloric requirements and their personal and cultural food preferences, along with sample meal plans and other supplemental educational materials to help them adopt and maintain the dietary pattern during this study. During this 8-week phase, they will also be instructed to eat 2 whole eggs per day to supplement the DASH eating pattern. | Other | DASH eating plan with eggs |
| DASH eating plan without eggsParticipants will receive guidance to follow a DASH dietary pattern tailored to their caloric requirements and their personal and cultural food preferences, along with sample meal plans and other supplemental educational materials to help them adopt and maintain the dietary pattern during this study. During this 8-week phase, they will also be instructed to exclude eggs from their diet on a daily basis. | Other | DASH eating plan without eggs |
Primary outcome
Endothelial function, % flow-mediated dilatation
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Endothelial function measured as percent flow-mediated dilatation in the right brachial artery.
Serum LDL cholesterol, mg/dL
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Serum low-density lipoprotein (LDL) will be calculated using the formula LDL = Tchol - (TG/5 + HDL). See below for secondary outcome measures of total cholesterol (Tchol), high-density lipoprotein (HDL) and triglycerides (TG).
20 secondary outcomes
High sensitivity C-reactive protein (CRP), mg/dL
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Total cholesterol (Tchol), mg/dL
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Triglycerides (TG), mg/dL
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
High-density lipoprotein (HDL), mg/dL
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Total/HDL cholesterol ratio
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Systolic blood pressure (SBP), mm Hg
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Diastolic blood pressure (DBP), mm Hg
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Mean arterial blood pressure, mm Hg
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Fasting blood glucose, mg/dL
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Fasting insulin, mIU/L
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Satiety, measured on a Visual Analogue Scale (VAS)
Time frame: At the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Body weight, kilograms
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Body mass index (BMI) (weight in kg/height in meters squared)
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Body fat, %
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Body water, %
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Visceral fat rating
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Waist circumference, cm
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Diet quality, using the Healthy Eating Index 2015 (HEI-2015)
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Physical activity level (PA), kilocalories
Time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Derived from this study: PubMed 40957619Njike VY, Ayettey RG, Foster JS, Comerford BP, Multany S, Gill AS. Effect of Daily Incorporation of Eggs in a Heart-Healthy Diet for 8 Weeks Compared with Their Exclusion on Cardio-Metabolic Risk Factors in Adults with Hyperlipidemia: A Randomized, Controlled, Crossover Trial. J Am Nutr Assoc. 2026 Mar-Apr;45(3):237-249. doi: 10.1080/27697061.2025.2560431. Epub 2025 Sep 16.
- 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.
Valentine Y. Njike, MD, MPH principal investigator
Griffin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH eating plan with eggs and DASH eating plan without eggs in people with Hyperlipidemias, run by Griffin Hospital 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 5 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 11 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rockiy G. Ayettey, MS, DHSc. (203-732-1125, rockiy.ayettey@yalegriffinprc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function, % flow-mediated dilatation (time frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs). 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?
On the ClinicalTrials.gov record for NCT05807334, 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 11 Apr 2023.