Clinical trial NCT02364570: Cardioprotective Activities Of Whole Eggs On Vascular Endothelial Function In Prediabetic Adults
Official title: Cardioprotective Activities Of Whole Eggs On Vascular Endothelial Function In Prediabetic Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Cardiovascular Disease
Keywords: CVD
Hyperglycemia
Postprandial
Vascular Function
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. fasting glucose 100-125 mg/dL,
2. non-dietary supplement user,
3. no medications affecting vasodilation, inflammation, or energy metabolism,
4. no CVD,
5. nonsmokers,
6. individuals having blood pressure \<130/85 mmHg and total cholesterol \<240 mg/dL.

Exclusion Criteria:

1. unstable weight (±2 kg),
2. vegetarian or egg allergy,
3. alcohol intake \>3 drinks/d or \>10 drinks/wk), or
4. ≥7 h/wk of aerobic activity.

Primary outcomes:
measure: Vascular Endothelial Function
timeFrame: Area under the curve of brachial artery FMD for 3 hours (0, 30, 60, 90, 120 min)
Secondary outcomes:
measure: Glucose
timeFrame: Area under the curve for plasma glucose for 3 hours (0, 30, 60, 90, 120 min)
measure: Oxidative Stress Biomarker (Malondialdehyde; MDA)
timeFrame: Area under curve of MDA for 3 hours (0, 30, 60, 90, 120, 150, 180 min)
measure: Insulin
timeFrame: Area under the curve for plasma insulin for 3 hours (0, 30, 60, 90, 120 min)
measure: Cholecystokinin (CCK)
timeFrame: Area under the curve for 3 hours (0, 30, 60, 90, 120 minutes)
measure: Methylglyoxal (MGO)
timeFrame: Area under the curve for methylglyoxal for 3 hours (0, 30, 60, 90, 120 min)
measure: 8-isoprostaglandin-F2a
timeFrame: Area under the curve for 8-isoprostaglandin-F2a for 3 hours (0, 30, 60, 90, 120 min)
measure: Arachidonic Acid (AA)
timeFrame: Area under the curve for arachidonic acid for 3 hours (0, 30, 60, 90, 120 min)
measure: 8-isoprostaglandin-F2a/Arachidonic Acid
timeFrame: Area under the curve for 8-isoprostaglandin-F2a/arachidonic acid for 3 hours (0, 30, 60, 90, 120 min)
measure: Nitric Oxide Metabolites (Nitrites/Nitrates) (NOx)
timeFrame: Area under the curve for NOx for 3 hours (0, 30, 60, 90, 120 min)
measure: Arginine (Arg)
timeFrame: Area under the curve for arginine for 3 hours (0, 30, 60, 90, 120 min)
measure: Asymmetric Dimethylarginine/Arginine (ADMA/Arg)
timeFrame: Area under the curve for ADMA/Arg for 3 hours (0, 30, 60, 90, 120 min)
measure: Symmetric Dimethylarginine/Arginine (SDMA/Arg)
timeFrame: Area under the curve for SDMA/Arg for 3 hours (0, 30, 60, 90, 120 min)
measure: Angiotensin-II
timeFrame: Area under the curve for angiotensin-II for 3 hours (0, 30, 60, 90, 120 min)
measure: Endothelin-I
timeFrame: Area under the curve for endothelin-I for 3 hours (0, 30, 60, 90, 120 min)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Richard Bruno, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: McDonald JD, Chitchumroonchokchai C, Li J, Mah E, Labyk AN, Reverri EJ, Ballard KD, Volek JS, Bruno RS. Replacing carbohydrate during a glucose challenge with the egg white portion or whole eggs protects against postprandial impairments in vascular endothelial function in prediabetic men by limiting increases in glycaemia and lipid peroxidation. Br J Nutr. 2018 Feb;119(3):259-270. doi: 10.1017/S0007114517003610. Epub 2018 Jan 16.
citation: McDonald JD, Mah E, Chitchumroonchokchai C, Reverri EJ, Li J, Volek JS, Villamena FA, Bruno RS. Co-ingestion of whole eggs or egg whites with glucose protects against postprandial hyperglycaemia-induced oxidative stress and dysregulated arginine metabolism in association with improved vascular endothelial function in prediabetic men. Br J Nutr. 2018 Oct;120(8):901-913. doi: 10.1017/S0007114518002192. Epub 2018 Aug 30.