Clinical trial NCT05807334: Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern in Hyperlipidemic Adults
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperlipidemias
Keywords: Hyperlipidemia
Cardio-metabolic
Endothelial function
Lead sponsor: Griffin Hospital
Sponsor class: OTHER
Collaborators: name: Egg Nutrition Center
First posted: 2023-04-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, crossover design, controlled trial
Primary purpose: PREVENTION

Brief 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.

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

1. 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.
2. 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.

Eligibility criteria: Inclusion Criteria:

1. Men \>18 years of age
2. Post-menopausal women not currently on hormone replacement therapy
3. Non-smokers
4. Overweight/obese (i.e., 25kg/m² ≤ BMI ≤ 40kg/m² and weight \<350pounds)
5. 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

Exclusion Criteria:

1. Failure to meet inclusion criteria
2. Anticipated inability to complete study protocol for any reason
3. Allergy to eggs
4. Current eating disorder
5. Restricted diets by choice that do not permit ingestion of eggs (e.g., vegan)
6. 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
7. Use of insulin, glucose-sensitizing medication, or vasoactive medication (including glucocorticoids, antineoplastic agents, some psychoactive agents, or bronchodilators)
8. Unstable use of antidepressant medications (i.e., change in dose during the three months prior to enrollment)
9. 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
10. Diagnosed diabetes
11. Diagnosed sleep apnea; unless treated and have been stable with their medications for at least 3 months
12. Established cardiovascular disease (including symptomatic coronary artery disease (CAD), myocardial infarction, peripheral vascular disease, congestive heart failure, carotid stenosis)
13. Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; current use of warfarin or other regular use of anticoagulation
14. Substance abuse (chronic alcoholism, other chemical dependency)
15. 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)
16. Conditions requiring regular use of NSAID medications such as Advil, naproxen, ibuprofen (examples of condition include lupus and rheumatoid arthritis)
17. For women: Use of hormone replacement therapy

Primary outcomes:
measure: Endothelial function, % flow-mediated dilatation
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Serum LDL cholesterol, mg/dL
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Secondary outcomes:
measure: High sensitivity C-reactive protein (CRP), mg/dL
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Total cholesterol (Tchol), mg/dL
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Triglycerides (TG), mg/dL
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: High-density lipoprotein (HDL), mg/dL
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Total/HDL cholesterol ratio
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Systolic blood pressure (SBP), mm Hg
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Diastolic blood pressure (DBP), mm Hg
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Mean arterial blood pressure, mm Hg
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Fasting blood glucose, mg/dL
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Fasting insulin, mIU/L
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Satiety, measured on a Visual Analogue Scale (VAS)
timeFrame: At the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Body weight, kilograms
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Body mass index (BMI) (weight in kg/height in meters squared)
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Body fat, %
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Body water, %
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Visceral fat rating
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Waist circumference, cm
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Diet quality, using the Healthy Eating Index 2015 (HEI-2015)
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
measure: Physical activity level (PA), kilocalories
timeFrame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs
Other outcomes:
Locations:
city: Derby
country: United States
facility: Yale-Griffin Prevention Research Center
state: Connecticut
Study officials:
affiliation: Griffin Hospital
name: Valentine Y. Njike, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: