Effects of Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern on Cardio-Metabolic Risk Factors and Diet Quality in Hyperlipidemic Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Endothelial function, % flow-mediated dilatation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
DASH eating plan with eggs
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.
干预措施: DASH eating plan with eggs (Other)
DASH eating plan without eggs
Participants will receive dietary guidance to follow the DASH eating plan while excluding eggs from their eating plan during this 8-week treatment period.
干预措施: DASH eating plan without eggs (Other)
结局指标
主要结局
Endothelial function, % flow-mediated dilatation
时间窗: 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
时间窗: 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).
次要结局
- Diastolic blood pressure (DBP), mm Hg(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(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(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(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(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(Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs)
- High sensitivity C-reactive protein (CRP), mg/dL(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(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(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)(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(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(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)(Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs)
- Body weight, kilograms(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(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: DASH eating plan with eggs; DASH eating plan without eggs)
- Body water, %(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(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)(Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs)
- Body fat, %(Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs)