NCT05807334招募中不适用
Effects of Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern on Cardio-Metabolic Risk Factors and Diet Quality in Hyperlipidemic Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 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
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
- 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)
- 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)
- 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)
研究者
研究点 (2)
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