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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02364570
Enrollment
20
Registered
2015-02-18
Start date
2015-01-31
Completion date
2017-06-30
Last updated
2019-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes, Cardiovascular Disease

Keywords

CVD, Hyperglycemia, Postprandial, Vascular Function

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.

Interventions

OTHERGlucose (100g)

Ingestion of glucose (100g)

OTHERGlucose (75g)

Ingestion of glucose (75g)

Ingestion of 1.5 whole eggs

Ingestion of 7 egg whites

Ingestion of 2 egg yolks

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Vascular Endothelial FunctionArea 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)

Secondary

MeasureTime frameDescription
GlucoseArea under the curve for plasma glucose for 3 hours (0, 30, 60, 90, 120 min)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)
Oxidative Stress Biomarker (Malondialdehyde; MDA)Area under curve of MDA for 3 hours (0, 30, 60, 90, 120, 150, 180 min)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)
InsulinArea under the curve for plasma insulin for 3 hours (0, 30, 60, 90, 120 min)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)
Cholecystokinin (CCK)Area under the curve for 3 hours (0, 30, 60, 90, 120 minutes)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)
Methylglyoxal (MGO)Area under the curve for methylglyoxal for 3 hours (0, 30, 60, 90, 120 min)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)
8-isoprostaglandin-F2aArea under the curve for 8-isoprostaglandin-F2a for 3 hours (0, 30, 60, 90, 120 min)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)
Arachidonic Acid (AA)Area under the curve for arachidonic acid for 3 hours (0, 30, 60, 90, 120 min)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)
8-isoprostaglandin-F2a/Arachidonic AcidArea under the curve for 8-isoprostaglandin-F2a/arachidonic acid for 3 hours (0, 30, 60, 90, 120 min)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)
Nitric Oxide Metabolites (Nitrites/Nitrates) (NOx)Area under the curve for NOx for 3 hours (0, 30, 60, 90, 120 min)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)
Arginine (Arg)Area under the curve for arginine for 3 hours (0, 30, 60, 90, 120 min)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)
Asymmetric Dimethylarginine/Arginine (ADMA/Arg)Area under the curve for ADMA/Arg for 3 hours (0, 30, 60, 90, 120 min)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)
Symmetric Dimethylarginine/Arginine (SDMA/Arg)Area under the curve for SDMA/Arg for 3 hours (0, 30, 60, 90, 120 min)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)
Angiotensin-IIArea under the curve for angiotensin-II for 3 hours (0, 30, 60, 90, 120 min)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)
Endothelin-IArea under the curve for endothelin-I for 3 hours (0, 30, 60, 90, 120 min)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)

Countries

United States

Participant flow

Participants by arm

ArmCount
All Study Participants
All study participants received all 4 interventions in a randomized order (Oral Glucose Tolerance Test, Glucose with Whole Eggs, Glucose with Egg Whites, Glucose with Egg Yolks). We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. FMD will be performed intermittently post-ingestion of the test meal 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.
20
Total20

Baseline characteristics

CharacteristicAll Study Participants
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
Age, Continuous31.9 years
STANDARD_DEVIATION 7.5
Body Mass Index31.1 kg/m^2
STANDARD_DEVIATION 2.5
Diastolic Blood Pressure72 mmHg
STANDARD_DEVIATION 3.6
Fasting Glucose6.0 mmol/L
STANDARD_DEVIATION 0.4
HDL Cholesterol0.64 mmol/L
STANDARD_DEVIATION 0.16
Insulin144.8 pmol/L
STANDARD_DEVIATION 15.8
LDL Cholesterol3.7 mmol/L
STANDARD_DEVIATION 0.8
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United States
20 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
20 Participants
Systolic Blood Pressure123 mmHg
STANDARD_DEVIATION 6
Total Cholesterol5.0 mmol/L
STANDARD_DEVIATION 0.6
Triglyceride1.5 mmol/L
STANDARD_DEVIATION 0.6

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 200 / 200 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 200 / 200 / 20

Outcome results

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)

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

ArmMeasureValue (MEAN)Dispersion
Oral Glucose Tolerance TestVascular Endothelial Function-294.4 %FMD*minStandard Error 41.35
Glucose With Whole EggsVascular Endothelial Function-152.9 %FMD*minStandard Error 36.9
Glucose With Egg WhitesVascular Endothelial Function-102.9 %FMD*minStandard Error 34.31
Glucose With Egg YolksVascular Endothelial Function-361.6 %FMD*minStandard Error 48.55
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)

Time frame: Area under the curve for 8-isoprostaglandin-F2a for 3 hours (0, 30, 60, 90, 120 min)

ArmMeasureValue (MEAN)Dispersion
Oral Glucose Tolerance Test8-isoprostaglandin-F2a767110 pmol/L*minStandard Error 187143
Glucose With Whole Eggs8-isoprostaglandin-F2a306758 pmol/L*minStandard Error 185617
Glucose With Egg Whites8-isoprostaglandin-F2a39117 pmol/L*minStandard Error 90562
Glucose With Egg Yolks8-isoprostaglandin-F2a718932 pmol/L*minStandard Error 199003
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)

Time frame: Area under the curve for 8-isoprostaglandin-F2a/arachidonic acid for 3 hours (0, 30, 60, 90, 120 min)

ArmMeasureValue (MEAN)Dispersion
Oral Glucose Tolerance Test8-isoprostaglandin-F2a/Arachidonic Acid1254.6 (pmol/L)/(umol/L)*minStandard Error 263.54
Glucose With Whole Eggs8-isoprostaglandin-F2a/Arachidonic Acid435.70 (pmol/L)/(umol/L)*minStandard Error 141.32
Glucose With Egg Whites8-isoprostaglandin-F2a/Arachidonic Acid538.81 (pmol/L)/(umol/L)*minStandard Error 100.61
Glucose With Egg Yolks8-isoprostaglandin-F2a/Arachidonic Acid1151.2 (pmol/L)/(umol/L)*minStandard Error 255.58
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)

Time frame: Area under the curve for angiotensin-II for 3 hours (0, 30, 60, 90, 120 min)

ArmMeasureValue (MEAN)Dispersion
Oral Glucose Tolerance TestAngiotensin-II1223.0 pg/mL*minStandard Error 146.47
Glucose With Whole EggsAngiotensin-II292.45 pg/mL*minStandard Error 55.01
Glucose With Egg WhitesAngiotensin-II316.19 pg/mL*minStandard Error 51.09
Glucose With Egg YolksAngiotensin-II341.89 pg/mL*minStandard Error 59.04
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)

Time frame: Area under the curve for arachidonic acid for 3 hours (0, 30, 60, 90, 120 min)

ArmMeasureValue (MEAN)Dispersion
Oral Glucose Tolerance TestArachidonic Acid (AA)-4771.6 umol/L*minStandard Error 2971.8
Glucose With Whole EggsArachidonic Acid (AA)-6408.8 umol/L*minStandard Error 2519.3
Glucose With Egg WhitesArachidonic Acid (AA)-6109.1 umol/L*minStandard Error 3093.4
Glucose With Egg YolksArachidonic Acid (AA)-10354 umol/L*minStandard Error 3273.3
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)

Time frame: Area under the curve for arginine for 3 hours (0, 30, 60, 90, 120 min)

ArmMeasureValue (MEAN)Dispersion
Oral Glucose Tolerance TestArginine (Arg)-3645.2 umol/L*minStandard Error 313.94
Glucose With Whole EggsArginine (Arg)-1714.4 umol/L*minStandard Error 227.65
Glucose With Egg WhitesArginine (Arg)503.67 umol/L*minStandard Error 506.09
Glucose With Egg YolksArginine (Arg)-1472.5 umol/L*minStandard Error 407
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)

Time frame: Area under the curve for ADMA/Arg for 3 hours (0, 30, 60, 90, 120 min)

ArmMeasureValue (MEAN)Dispersion
Oral Glucose Tolerance TestAsymmetric Dimethylarginine/Arginine (ADMA/Arg)195.86 (nmol/L)/(umol/L)*minStandard Error 29.75
Glucose With Whole EggsAsymmetric Dimethylarginine/Arginine (ADMA/Arg)59.30 (nmol/L)/(umol/L)*minStandard Error 22.83
Glucose With Egg WhitesAsymmetric Dimethylarginine/Arginine (ADMA/Arg)-44.04 (nmol/L)/(umol/L)*minStandard Error 21.57
Glucose With Egg YolksAsymmetric Dimethylarginine/Arginine (ADMA/Arg)118.62 (nmol/L)/(umol/L)*minStandard Error 23.36
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)

Time frame: Area under the curve for 3 hours (0, 30, 60, 90, 120 minutes)

ArmMeasureValue (MEAN)Dispersion
Oral Glucose Tolerance TestCholecystokinin (CCK)-254.018 pmol/L*minStandard Error 54.122
Glucose With Whole EggsCholecystokinin (CCK)93.659 pmol/L*minStandard Error 72.54
Glucose With Egg WhitesCholecystokinin (CCK)-29.193 pmol/L*minStandard Error 80.656
Glucose With Egg YolksCholecystokinin (CCK)-150.550 pmol/L*minStandard Error 78.186
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)

Time frame: Area under the curve for endothelin-I for 3 hours (0, 30, 60, 90, 120 min)

ArmMeasureValue (MEAN)Dispersion
Oral Glucose Tolerance TestEndothelin-I27.08 pg/mL*minStandard Error 7.03
Glucose With Whole EggsEndothelin-I-13.29 pg/mL*minStandard Error 10.32
Glucose With Egg WhitesEndothelin-I-1.97 pg/mL*minStandard Error 11.29
Glucose With Egg YolksEndothelin-I5.59 pg/mL*minStandard Error 10.08
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)

Time frame: Area under the curve for plasma glucose for 3 hours (0, 30, 60, 90, 120 min)

ArmMeasureValue (MEAN)Dispersion
Oral Glucose Tolerance TestGlucose461.9 mmol/L*minStandard Error 77.78
Glucose With Whole EggsGlucose247.5 mmol/L*minStandard Error 52.67
Glucose With Egg WhitesGlucose296.1 mmol/L*minStandard Error 61.16
Glucose With Egg YolksGlucose390.6 mmol/L*minStandard Error 51.13
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)

Time frame: Area under the curve for plasma insulin for 3 hours (0, 30, 60, 90, 120 min)

ArmMeasureValue (MEAN)Dispersion
Oral Glucose Tolerance TestInsulin99433 mmol/L*minStandard Error 14623
Glucose With Whole EggsInsulin73970 mmol/L*minStandard Error 14917
Glucose With Egg WhitesInsulin72645 mmol/L*minStandard Error 15709
Glucose With Egg YolksInsulin79235 mmol/L*minStandard Error 16634
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)

Time frame: Area under the curve for methylglyoxal for 3 hours (0, 30, 60, 90, 120 min)

ArmMeasureValue (MEAN)Dispersion
Oral Glucose Tolerance TestMethylglyoxal (MGO)2318.9 nmol/L*minStandard Error 394.61
Glucose With Whole EggsMethylglyoxal (MGO)1807.4 nmol/L*minStandard Error 264.49
Glucose With Egg WhitesMethylglyoxal (MGO)1742.3 nmol/L*minStandard Error 244.57
Glucose With Egg YolksMethylglyoxal (MGO)2611.8 nmol/L*minStandard Error 229.58
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)

Time frame: Area under the curve for NOx for 3 hours (0, 30, 60, 90, 120 min)

ArmMeasureValue (MEAN)Dispersion
Oral Glucose Tolerance TestNitric Oxide Metabolites (Nitrites/Nitrates) (NOx)-1213.9 umol/L*minStandard Error 231.31
Glucose With Whole EggsNitric Oxide Metabolites (Nitrites/Nitrates) (NOx)-39.71 umol/L*minStandard Error 277.07
Glucose With Egg WhitesNitric Oxide Metabolites (Nitrites/Nitrates) (NOx)-245.34 umol/L*minStandard Error 225.96
Glucose With Egg YolksNitric Oxide Metabolites (Nitrites/Nitrates) (NOx)607.12 umol/L*minStandard Error 315.01
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)

Time frame: Area under curve of MDA for 3 hours (0, 30, 60, 90, 120, 150, 180 min)

ArmMeasureValue (MEAN)Dispersion
Oral Glucose Tolerance TestOxidative Stress Biomarker (Malondialdehyde; MDA)52.97 umol/L*minStandard Error 8.674
Glucose With Whole EggsOxidative Stress Biomarker (Malondialdehyde; MDA)16.51 umol/L*minStandard Error 8.978
Glucose With Egg WhitesOxidative Stress Biomarker (Malondialdehyde; MDA)30.04 umol/L*minStandard Error 4.996
Glucose With Egg YolksOxidative Stress Biomarker (Malondialdehyde; MDA)59.2 umol/L*minStandard Error 3.728
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)

Time frame: Area under the curve for SDMA/Arg for 3 hours (0, 30, 60, 90, 120 min)

ArmMeasureValue (MEAN)Dispersion
Oral Glucose Tolerance TestSymmetric Dimethylarginine/Arginine (SDMA/Arg)178.48 (nmol/L)/(umol/L)*minStandard Error 17.19
Glucose With Whole EggsSymmetric Dimethylarginine/Arginine (SDMA/Arg)62.43 (nmol/L)/(umol/L)*minStandard Error 17.5
Glucose With Egg WhitesSymmetric Dimethylarginine/Arginine (SDMA/Arg)-37.95 (nmol/L)/(umol/L)*minStandard Error 18.72
Glucose With Egg YolksSymmetric Dimethylarginine/Arginine (SDMA/Arg)86.03 (nmol/L)/(umol/L)*minStandard Error 11.88

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026