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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364570
• Other study ID #: 2014H0307
• Secondary ID: 2014H0307
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: June 2017

Study information

• Verified date: May 2019
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Prediabetes
• Prediabetic State

Intervention

Other:
• Glucose (100g)
Ingestion of glucose (100g)
• Glucose (75g)
Ingestion of glucose (75g)
• Whole Eggs
Ingestion of 1.5 whole eggs
• Egg Whites
Ingestion of 7 egg whites
• Egg Yolks
Ingestion of 2 egg yolks

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (13)

Blesso CN, Andersen CJ, Barona J, Volek JS, Fernandez ML. Whole egg consumption improves lipoprotein profiles and insulin sensitivity to a greater extent than yolk-free egg substitute in individuals with metabolic syndrome. Metabolism. 2013 Mar;62(3):400-10. doi: 10.1016/j.metabol.2012.08.014. Epub 2012 Sep 27. — View Citation

Dávalos A, Miguel M, Bartolomé B, López-Fandiño R. Antioxidant activity of peptides derived from egg white proteins by enzymatic hydrolysis. J Food Prot. 2004 Sep;67(9):1939-44. — View Citation

DECODE Study Group, the European Diabetes Epidemiology Group. Glucose tolerance and cardiovascular mortality: comparison of fasting and 2-hour diagnostic criteria. Arch Intern Med. 2001 Feb 12;161(3):397-405. — View Citation

Djoussé L, Gaziano JM. Egg consumption in relation to cardiovascular disease and mortality: the Physicians' Health Study. Am J Clin Nutr. 2008 Apr;87(4):964-9. — View Citation

Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. — View Citation

Hu Y, Liu W, Huang R, Zhang X. Postchallenge plasma glucose excursions, carotid intima-media thickness, and risk factors for atherosclerosis in Chinese population with type 2 diabetes. Atherosclerosis. 2010 May;210(1):302-6. doi: 10.1016/j.atherosclerosis.2009.11.015. Epub 2009 Nov 20. — View 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. — View 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. — View Citation

Nakamura Y, Iso H, Kita Y, Ueshima H, Okada K, Konishi M, Inoue M, Tsugane S. Egg consumption, serum total cholesterol concentrations and coronary heart disease incidence: Japan Public Health Center-based prospective study. Br J Nutr. 2006 Nov;96(5):921-8. — View Citation

Nimalaratne C, Lopes-Lutz D, Schieber A, Wu J. Effect of domestic cooking methods on egg yolk xanthophylls. J Agric Food Chem. 2012 Dec 26;60(51):12547-52. doi: 10.1021/jf303828n. Epub 2012 Dec 14. — View Citation

Sauvaget C, Nagano J, Allen N, Grant EJ, Beral V. Intake of animal products and stroke mortality in the Hiroshima/Nagasaki Life Span Study. Int J Epidemiol. 2003 Aug;32(4):536-43. — View Citation

Scrafford CG, Tran NL, Barraj LM, Mink PJ. Egg consumption and CHD and stroke mortality: a prospective study of US adults. Public Health Nutr. 2011 Feb;14(2):261-70. doi: 10.1017/S1368980010001874. Epub 2010 Jul 16. — View Citation

U.S. Dept of Agriculture and U.S. Dept of Health and Human Services (2010) Dietary Guidelines for Americans. 7th Ed.

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular Endothelial Function	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)	Area under the curve of brachial artery FMD for 3 hours (0, 30, 60, 90, 120 min)
Secondary	Glucose	Glucose concentrations evaluated on the basis as change from baseline to calculate glucose area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in glucose from 0 min to 180 min (i.e., AUC (glucose 0 min- 0 min, glucose 30 min-0 min, glucose 60 min-0 min, etc)	Area under the curve for plasma glucose for 3 hours (0, 30, 60, 90, 120 min)
Secondary	Oxidative Stress Biomarker (Malondialdehyde; MDA)	MDA concentrations evaluated on the basis as change from baseline to calculate MDAarea under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in MDA from 0 min to 180 min (i.e., AUC (MDA 0 min- 0 min, MDA 30 min-0 min, MDA 60 min-0 min, etc)	Area under curve of MDA for 3 hours (0, 30, 60, 90, 120, 150, 180 min)
Secondary	Insulin	Insulin concentrations evaluated on the basis as change from baseline to calculate insulin area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in insulin from 0 min to 180 min (i.e., AUC (Insulin 0 min- 0 min, insulin 30 min-0 min, insulin 60 min-0 min, etc)	Area under the curve for plasma insulin for 3 hours (0, 30, 60, 90, 120 min)
Secondary	Cholecystokinin (CCK)	CCK concentrations evaluated on the basis as change from baseline to calculate CCK area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in CCK from 0 min to 180 min (i.e., AUC (CCK 0 min- 0 min, CCK 30 min-0 min, CCK 60 min-0 min, etc)	Area under the curve for 3 hours (0, 30, 60, 90, 120 minutes)
Secondary	Methylglyoxal (MGO)	MGO concentrations evaluated on the basis as change from baseline to calculate MGO area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in MGO from 0 min to 180 min (i.e., AUC (MGO 0 min- 0 min, MGO 30 min-0 min, MGO 60 min-0 min, etc)	Area under the curve for methylglyoxal for 3 hours (0, 30, 60, 90, 120 min)
Secondary	8-isoprostaglandin-F2a	8-isoprostaglandin-F2a concentrations evaluated on the basis as change from baseline to calculate 8-isoprostaglandin-F2a area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in 8-isoprostaglandin-F2a from 0 min to 180 min (i.e., AUC (8-isoprostaglandin-F2a 0 min- 0 min, 8-isoprostaglandin-F2a 30 min-0 min, 8-isoprostaglandin-F2a 60 min-0 min, etc)	Area under the curve for 8-isoprostaglandin-F2a for 3 hours (0, 30, 60, 90, 120 min)
Secondary	Arachidonic Acid (AA)	Arachidonic acid concentrations evaluated on the basis as change from baseline to calculate arachidonic acid area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in arachidonic acid from 0 min to 180 min (i.e., AUC (arachidonic acid 0 min- 0 min, arachidonic acid 30 min-0 min, arachidonic acid 60 min-0 min, etc)	Area under the curve for arachidonic acid for 3 hours (0, 30, 60, 90, 120 min)
Secondary	8-isoprostaglandin-F2a/Arachidonic Acid	8-isoprostaglandin-F2a/arachidonic acid concentrations evaluated on the basis as change from baseline to calculate 8-isoprostaglandin-F2a/arachidonic acid area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in 8-isoprostaglandin-F2a/arachidonic acid from 0 min to 180 min (i.e., AUC (8-isoprostaglandin-F2a/arachidonic acid 0 min- 0 min, 8-isoprostaglandin-F2a/arachidonic acid 30 min-0 min, 8-isoprostaglandin-F2a/arachidonic acid 60 min-0 min, etc)	Area under the curve for 8-isoprostaglandin-F2a/arachidonic acid for 3 hours (0, 30, 60, 90, 120 min)
Secondary	Nitric Oxide Metabolites (Nitrites/Nitrates) (NOx)	Biomarker of nitric oxide homeostasis is based on the assessment of total nitrite and nitrate concentrations. Changes relative to baseline were used to calculate area under the curve of total nitric oxide metabolites from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in nitric oxide homeostasis from 0 min to 180 min (i.e., AUC (NOx 0 min- 0 min, NOx 30 min-0 min, NOx 60 min-0 min, etc)	Area under the curve for NOx for 3 hours (0, 30, 60, 90, 120 min)
Secondary	Arginine (Arg)	Arginine concentrations evaluated on the basis as change from baseline to calculate arginine area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in arginine from 0 min to 180 min (i.e., AUC (arginine 0 min- 0 min, arginine 30 min-0 min, arginine 60 min-0 min, etc)	Area under the curve for arginine for 3 hours (0, 30, 60, 90, 120 min)
Secondary	Asymmetric Dimethylarginine/Arginine (ADMA/Arg)	ADMA/Arg concentrations evaluated on the basis as change from baseline to calculate ADMA/Arg area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in ADMA/Arg from 0 min to 180 min (i.e., AUC (ADMA/Arg 0 min- 0 min, ADMA/Arg 30 min-0 min, ADMA/Arg 60 min-0 min, etc)	Area under the curve for ADMA/Arg for 3 hours (0, 30, 60, 90, 120 min)
Secondary	Symmetric Dimethylarginine/Arginine (SDMA/Arg)	SDMA/Arg concentrations evaluated on the basis as change from baseline to calculate SDMA/Arg area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in SDMA/Arg from 0 min to 180 min (i.e., AUC (SDMA/Arg 0 min- 0 min, SDMA/Arg 30 min-0 min, SDMA/Arg 60 min-0 min, etc)	Area under the curve for SDMA/Arg for 3 hours (0, 30, 60, 90, 120 min)
Secondary	Angiotensin-II	Angiotensin-II concentrations evaluated on the basis as change from baseline to calculate angiotensin-II area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in angiotensin-II from 0 min to 180 min (i.e., AUC (angiotensin-II 0 min- 0 min, angiotensin-II 30 min-0 min, angiotensin-II 60 min-0 min, etc)	Area under the curve for angiotensin-II for 3 hours (0, 30, 60, 90, 120 min)
Secondary	Endothelin-I	Endothelin-I concentrations evaluated on the basis as change from baseline to calculate endothelin-I area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in endothelin-I from 0 min to 180 min (i.e., AUC (endothelin-I 0 min- 0 min, endothelin-I 30 min-0 min, endothelin-I 60 min-0 min, etc)	Area under the curve for endothelin-I for 3 hours (0, 30, 60, 90, 120 min)