跳至主要内容
临床试验/NCT02364570
NCT02364570已完成不适用

Cardioprotective Activities Of Whole Eggs On Vascular Endothelial Function In Prediabetic Adults

Ohio State University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Vascular Endothelial Function

研究概览

简要总结

Cardiovascular disease (CVD) is largely a lifestyle-related condition that is the #1 killer of adults in the United States. Our work is aimed at understanding how short-term increases in blood sugar, like those that accompany eating a meal, affect blood vessel function and the risk of CVD. This research is aimed at understanding how meals composed of eggs affect short-term increases in blood sugar from eating, which are connected with increased risk of CVD. In particular, the investigators are trying to identify a specific meal composed of either whole eggs, egg yolks, or egg whites, that best reduces acute increases in blood sugar brought on by meals that consist of majority carbohydrate. At the same time, the investigators are trying to explore the protective affects that eggs may have on blood vessel function and the reduction of CVD risk.

详细描述

Cardiovascular disease (CVD) is the leading cause of death in the United States [1]. The inability of your blood vessels to properly enlarge and shrink, known as vascular endothelial dysfunction (VED), is an early event leading to CVD and can be caused by postprandial hyperglycemia (PPH) [1] or short-term increases in blood sugar that occur after you have eaten. Although we do not know how this occurs, research shows that temporary increases in blood sugar impair the blood vessel's ability to properly enlarge and shrink. We also know that impaired vessel function is an early event leading to CVD and that research shows that short-term increases in blood sugar impair blood vessel function, even in healthy people [2].

Because high blood levels of cholesterol increase CVD risk, this has triggered flawed guidelines to restrict cholesterol in our diet [3], including limiting egg consumption. The misguided fear towards eating eggs has been routinely challenged by large-scale studies failing to associate eggs with heart disease risk [4-8]. Research shows that eggs improve the functioning of insulin to reduce blood sugar [9]. They also contain bioactive peptides that may attenuate oxidative stress [10-11]. This provides rationale for their study as a dietary strategy to reduce PPH and VED. Thus, the objective of this study is to define the potential benefits of eggs and its components (egg yolk and egg whites) on blood vessel health in adults with prediabetes.

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 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • fasting glucose 100-125 mg/dL,
  • non-dietary supplement user,
  • no medications affecting vasodilation, inflammation, or energy metabolism,
  • nonsmokers,
  • individuals having blood pressure <130/85 mmHg and total cholesterol <240 mg/dL.

排除标准

  • unstable weight (±2 kg),
  • vegetarian or egg allergy,
  • alcohol intake >3 drinks/d or >10 drinks/wk), or
  • ≥7 h/wk of aerobic activity.

研究组 & 干预措施

Oral Glucose Tolerance Test

Active Comparator

We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.

干预措施: Glucose (100g) (Other)

Glucose with Whole Eggs

Experimental

We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (75 g) with 1.5 whole eggs (cooked). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.

干预措施: Glucose (75g) (Other)

Glucose with Whole Eggs

Experimental

We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (75 g) with 1.5 whole eggs (cooked). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.

干预措施: Whole Eggs (Other)

Glucose with Egg Whites

Experimental

We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (75 g) with 7 egg whites (cooked). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.

干预措施: Glucose (75g) (Other)

Glucose with Egg Whites

Experimental

We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (75 g) with 7 egg whites (cooked). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.

干预措施: Egg Whites (Other)

Glucose with Egg Yolks

Experimental

We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (75 g) with 2 egg yolks (cooked). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.

干预措施: Glucose (75g) (Other)

Glucose with Egg Yolks

Experimental

We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (75 g) with 2 egg yolks (cooked). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.

干预措施: Egg Yolks (Other)

结局指标

主要结局

Vascular Endothelial Function

时间窗: Area under the curve of brachial artery FMD for 3 hours (0, 30, 60, 90, 120 min)

Flow mediated dilation (FMD) evaluated on the basis as change from baseline to calculate FMD area under the curve from 0-180 min, i.e. i.e. Area Under the Curve (AUC) of change from baseline in FMD from 0 min to 180 min (i.e., AUC (FMD 0 min- 0 min, FMD 30 min-0 min, FMD 60 min-0 min, etc)

次要结局

  • Glucose(Area under the curve for plasma glucose for 3 hours (0, 30, 60, 90, 120 min))
  • Oxidative Stress Biomarker (Malondialdehyde; MDA)(Area under curve of MDA for 3 hours (0, 30, 60, 90, 120, 150, 180 min))
  • Insulin(Area under the curve for plasma insulin for 3 hours (0, 30, 60, 90, 120 min))
  • Cholecystokinin (CCK)(Area under the curve for 3 hours (0, 30, 60, 90, 120 minutes))
  • Methylglyoxal (MGO)(Area under the curve for methylglyoxal for 3 hours (0, 30, 60, 90, 120 min))
  • 8-isoprostaglandin-F2a(Area under the curve for 8-isoprostaglandin-F2a for 3 hours (0, 30, 60, 90, 120 min))
  • Arachidonic Acid (AA)(Area under the curve for arachidonic acid for 3 hours (0, 30, 60, 90, 120 min))
  • 8-isoprostaglandin-F2a/Arachidonic Acid(Area under the curve for 8-isoprostaglandin-F2a/arachidonic acid for 3 hours (0, 30, 60, 90, 120 min))
  • Nitric Oxide Metabolites (Nitrites/Nitrates) (NOx)(Area under the curve for NOx for 3 hours (0, 30, 60, 90, 120 min))
  • Arginine (Arg)(Area under the curve for arginine for 3 hours (0, 30, 60, 90, 120 min))
  • Asymmetric Dimethylarginine/Arginine (ADMA/Arg)(Area under the curve for ADMA/Arg for 3 hours (0, 30, 60, 90, 120 min))
  • Symmetric Dimethylarginine/Arginine (SDMA/Arg)(Area under the curve for SDMA/Arg for 3 hours (0, 30, 60, 90, 120 min))
  • Angiotensin-II(Area under the curve for angiotensin-II for 3 hours (0, 30, 60, 90, 120 min))
  • Endothelin-I(Area under the curve for endothelin-I for 3 hours (0, 30, 60, 90, 120 min))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Bruno

Associate Professor and Principal Investigator

Ohio State University

研究点 (2)

Loading locations...

相似试验