PrediabetesNCT02364570

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

A study testing Glucose (100g), Glucose (75g) and Whole Eggs in people with Prediabetes and Cardiovascular Disease, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Prediabetes, Cardiovascular Disease
What is being tested?: Glucose (100g), Glucose (75g) and Whole Eggs
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Jan 2015to Jun 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University
Columbus, Ohio, 43210

Other trials in United States

About this study

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.

Read the 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.

Conditions: Prediabetes, Cardiovascular Disease
Being tested: Glucose (100g), Glucose (75g), Whole Eggs, Egg Whites, Egg Yolks
Keywords: CVD, Hyperglycemia, Postprandial, Vascular Function
Medical subject headings: Prediabetic State, Cardiovascular Diseases, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Glucose (100g)Other
Ingestion of glucose (100g)
Glucose (75g)Other
Ingestion of glucose (75g)
Whole EggsOther
Ingestion of 1.5 whole eggs
Egg WhitesOther
Ingestion of 7 egg whites
Egg YolksOther
Ingestion of 2 egg yolks

Study groups in NCT02364570
Study group	Role	What they receive
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. Receives: Other: Glucose (100g)
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. Receives: Other: Glucose (75g); Other: Whole Eggs
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. Receives: Other: Glucose (75g); Other: Egg Whites
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. Receives: Other: Glucose (75g); Other: Egg Yolks

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (14)

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)
Measured: Area under the curve for plasma glucose for 3 hours (0, 30, 60, 90, 120 min)
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)
Measured: Area under curve of MDA for 3 hours (0, 30, 60, 90, 120, 150, 180 min)
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)
Measured: Area under the curve for plasma insulin for 3 hours (0, 30, 60, 90, 120 min)
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)
Measured: Area under the curve for 3 hours (0, 30, 60, 90, 120 minutes)
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)
Measured: Area under the curve for methylglyoxal for 3 hours (0, 30, 60, 90, 120 min)
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)
Measured: Area under the curve for 8-isoprostaglandin-F2a for 3 hours (0, 30, 60, 90, 120 min)
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)
Measured: Area under the curve for arachidonic acid for 3 hours (0, 30, 60, 90, 120 min)
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)
Measured: 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)
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)
Measured: Area under the curve for NOx for 3 hours (0, 30, 60, 90, 120 min)
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)
Measured: Area under the curve for arginine for 3 hours (0, 30, 60, 90, 120 min)
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)
Measured: Area under the curve for ADMA/Arg for 3 hours (0, 30, 60, 90, 120 min)
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)
Measured: Area under the curve for SDMA/Arg for 3 hours (0, 30, 60, 90, 120 min)
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)
Measured: Area under the curve for angiotensin-II for 3 hours (0, 30, 60, 90, 120 min)
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)
Measured: Area under the curve for endothelin-I for 3 hours (0, 30, 60, 90, 120 min)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Jun 2017

First posted18 Feb 2015 (estimated)
Study startJan 2015
Primary completionAug 2016
Study completionJun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for PrediabetesStudies of the same condition, open and under way.
More trials run by Ohio State UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02364570
Sponsor's protocol ID: 2014H0307
Other IDs: 2014H0307
Status last verified: May 2019
First submitted: 4 Feb 2015
Last updated: 3 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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. No abstract available.
PubMed 24352519
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. doi: 10.1001/archinte.161.3.397.
PubMed 11176766
U.S. Dept of Agriculture and U.S. Dept of Health and Human Services (2010) Dietary Guidelines for Americans. 7th Ed.
Djousse 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. doi: 10.1093/ajcn/87.4.964.
PubMed 18400720
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.
PubMed 20005514
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. doi: 10.1017/bjn20061937.
PubMed 17092383
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. doi: 10.1093/ije/dyg151.
PubMed 12913025
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.
PubMed 20633314
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.
PubMed 23021013
Davalos A, Miguel M, Bartolome B, Lopez-Fandino R. Antioxidant activity of peptides derived from egg white proteins by enzymatic hydrolysis. J Food Prot. 2004 Sep;67(9):1939-44. doi: 10.4315/0362-028x-67.9.1939.
PubMed 15453585
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.
PubMed 23205520
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.
PubMed 29335039
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.
PubMed 30160222

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cardioprotective Activities Of Whole Eggs On Vascular Endothelial Function In Prediabetic Adults
ClinicalTrials.gov ID: NCT02364570
Acronym / sponsor ID: 2014H0307
Conditions: Prediabetes, Cardiovascular Disease
Keywords: CVD, Hyperglycemia, Postprandial, Vascular Function
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Ohio State UniversityUniversity, hospital or other
Study start: Jan 2015
Primary completion: Aug 2016 (actual)
Study completion: Jun 2017 (actual)
First posted: 18 Feb 2015 (estimated)
Results: Posted 29 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Oral Glucose Tolerance Test	Active comparator	Other: Glucose (100g)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.
Glucose with Whole Eggs	Experimental	Other: Glucose (75g), Other: Whole EggsWe 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.
Glucose with Egg Whites	Experimental	Other: Glucose (75g), Other: Egg WhitesWe 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.
Glucose with Egg Yolks	Experimental	Other: Glucose (75g), Other: Egg YolksWe 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.

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

fasting glucose 100-125 mg/dL,
non-dietary supplement user,
no medications affecting vasodilation, inflammation, or energy metabolism,
no CVD,
nonsmokers,

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Glucose (100g)Ingestion of glucose (100g)	Other	Oral Glucose Tolerance Test
Glucose (75g)Ingestion of glucose (75g)	Other	Glucose with Egg Whites, Glucose with Egg Yolks, Glucose with Whole Eggs
Whole EggsIngestion of 1.5 whole eggs	Other	Glucose with Whole Eggs
Egg WhitesIngestion of 7 egg whites	Other	Glucose with Egg Whites
Egg YolksIngestion of 2 egg yolks	Other	Glucose with Egg Yolks

Primary outcome

Vascular Endothelial Function
Time frame: 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)

14 secondary outcomes

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

Results and safety

Results posted to the registry on 29 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Glucose, Then Whole Egg, Then Egg White, Then Egg Yolk	1	1
Glucose, Then Egg White, Then Whole Egg, Then Egg Yolk	1	1
Glucose, Then Egg Yolk, Then Egg White, Then Whole Egg	2	2
Glucose, Then Egg Yolk, Then Whole Egg, Then Egg White	1	1
Glucose, Then Whole Egg, Then Egg Yolk, Then Egg White	1	1
Glucose, Then Egg White, Then Egg Yolk, Then Whole Egg	1	1
Whole Egg, Then Egg White, Then Egg Yolk, Then Glucose	2	2
Whole Egg, Then Egg Yolk, Then Egg White, Then Glucose	1	1
Whole Egg, Then Glucose, Then Egg Yolk, Then Egg White	2	2
Egg White, Then Glucose, Then Whole Egg, Then Egg Yolk	1	1
Egg White, Then Egg Yolk, Then Whole Egg, Then Glucose	1	1
Whole Egg, Then Glucose, Then Egg White, Then Egg Yolk	1	1
Egg Yolk, Then Egg White, Then Whole Egg, Then Glucose	1	1
Egg Yolk, Then Whole Egg, Then Glucose, Then Egg White	2	2
Egg Yolk, Then Glucose, Then Egg White, Then Whole Egg	1	1
Egg Yolk, Then Egg White, Then Glucose, Then Whole Egg	1	1

Primary outcome: Vascular Endothelial Function

Time frame: Area under the curve of brachial artery FMD for 3 hours (0, 30, 60, 90, 120 min). Mean (Standard Error). Unit: %FMD*min

Measure	Oral Glucose Tolerance Test n = 20	Glucose With Whole Eggs n = 20	Glucose With Egg Whites n = 20	Glucose With Egg Yolks n = 20
Value	-294.4 (41.35)	-152.9 (36.9)	-102.9 (34.31)	-361.6 (48.55)

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were monitored for any adverse events in response to a glucose challenge in the absence or presence of egg-based meals through study completion (~6 total weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oral Glucose Tolerance Test	0 of 20 (0%)	0 of 20 (0%)	Not reported
Glucose With Whole Eggs	0 of 20 (0%)	0 of 20 (0%)	Not reported
Glucose With Egg Whites	0 of 20 (0%)	0 of 20 (0%)	Not reported
Glucose With Egg Yolks	0 of 20 (0%)	0 of 20 (0%)	Not reported

Limitations and caveats (from the sponsor): This study replaced carbohydrate in a glucose challenge with isocaloric amounts of whole eggs, egg whites, and egg yolks. Future studies should consider equi-carbohydrate based meals with or without equal portions of egg components.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24352519Go 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. No abstract available.
Background: PubMed 11176766DECODE 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. doi: 10.1001/archinte.161.3.397.
BackgroundU.S. Dept of Agriculture and U.S. Dept of Health and Human Services (2010) Dietary Guidelines for Americans. 7th Ed.
Background: PubMed 18400720Djousse 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. doi: 10.1093/ajcn/87.4.964.
Background: PubMed 20005514Hu 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.
Background: PubMed 17092383Nakamura 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. doi: 10.1017/bjn20061937.
Background: PubMed 12913025Sauvaget 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. doi: 10.1093/ije/dyg151.
Background: PubMed 20633314Scrafford 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.
Background: PubMed 23021013Blesso 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.
Background: PubMed 15453585Davalos A, Miguel M, Bartolome B, Lopez-Fandino R. Antioxidant activity of peptides derived from egg white proteins by enzymatic hydrolysis. J Food Prot. 2004 Sep;67(9):1939-44. doi: 10.4315/0362-028x-67.9.1939.
Background: PubMed 23205520Nimalaratne 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.
Background: PubMed 29335039McDonald 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Bruno, PhD, RD principal investigator

Ohio State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Glucose (100g), Glucose (75g) and Whole Eggs in people with Prediabetes and Cardiovascular Disease, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vascular Endothelial Function (time frame: Area under the curve of brachial artery FMD for 3 hours (0, 30, 60, 90, 120 min)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02364570, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.