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

NCT02364570 | Completed Results

• 1 other identifier: 2014H0307
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetes; Cardiovascular Disease

Keywords

CVD; Hyperglycemia; Postprandial; Vascular Function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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)

Study Arms (4)

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.

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.

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.

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.

Other: Glucose (75g); Other: Egg Yolks

Interventions

Glucose (100g) OTHER

Ingestion of glucose (100g)

Oral Glucose Tolerance Test

Glucose (75g) OTHER

Ingestion of glucose (75g)

Glucose with Egg Whites; Glucose with Egg Yolks; Glucose with Whole Eggs

Whole Eggs OTHER

Ingestion of 1.5 whole eggs

Glucose with Whole Eggs

Egg Whites OTHER

Ingestion of 7 egg whites

Glucose with Egg Whites

Egg Yolks OTHER

Ingestion of 2 egg yolks

Glucose with Egg Yolks

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (13)

• 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.

  PMID: 24352519 BACKGROUND

• 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.

  PMID: 11176766 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 18400720 BACKGROUND

• 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.

  PMID: 20005514 BACKGROUND

• 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.

  PMID: 17092383 BACKGROUND

• 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.

  PMID: 12913025 BACKGROUND

• 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.

  PMID: 20633314 BACKGROUND

• 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.

  PMID: 23021013 BACKGROUND

• 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.

  PMID: 15453585 BACKGROUND

• 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.

  PMID: 23205520 BACKGROUND

• 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.

  PMID: 29335039 BACKGROUND

• 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.

  PMID: 30160222 BACKGROUND

MeSH Terms

Conditions

Prediabetic State; Cardiovascular Diseases; Hyperglycemia

Interventions

Glucose; Egg White; Egg Yolk

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Eggs; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

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.

Results Point of Contact

• Title: Richard Bruno, PhD, RD
• Organization: The Ohio State University

bruno.27@osu.edu

6142925522

Study Officials

• Richard Bruno, PhD, RD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Principal Investigator

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 18, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: June 1, 2017
• Last Updated: May 3, 2019
• Results First Posted: April 29, 2019

Record last verified: 2019-05

Locations

US (1)