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Cardiovascular disease (CVD) is the leading cause of death in the United States. Short-term increases in blood sugar, or postprandial hyperglycemia (PPH), affect blood vessel function and increase the risk of CVD. Greater intakes of dairy foods have been associated with a lower risk of CVD, but whether these effects occur directly or indirectly by displacing foods in the diet that might increase CVD risk is unclear. The health benefits of dairy on heart health are at least partly attributed to its ability to limit PPH and resulting PPH-mediated responses leading to vascular dysfunction. This provides rationale to further investigate dairy as a dietary strategy to reduce PPH and risk for CVD. The objective of this study is to define the extent to which dairy milk, and its whey and casein protein fractions, protect against postprandial vascular dysfunction by reducing oxidative stress responses that limit nitric oxide bioavailability to the vascular endothelium in adults with prediabetes.
This study consists of four, 3-hour postprandial trials in response to consuming the following dietary treatments: 1. oral glucose challenge, 2. oral glucose challenge in combination with non-fat milk, 3. oral glucose challenge in combination with whey protein isolate, and 4. oral glucose challenge in combination with sodium caseinate. For three days preceding each trial, participants will be provided all meals to standardize physiologic responses to test meals. On each trial day, vascular function will be assessed and blood samples collected prior to and at 30 minute intervals for 3 hours following test meal ingestion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucose | Active Comparator | This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. |
|
| Glucose with Non-fat Milk | Experimental | This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. |
|
| Glucose with Whey Protein Isolate | Experimental | This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. |
|
| Glucose with Sodium Caseinate | Experimental | This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucose | Other | Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vascular Endothelial Function | Flow mediated dilation (FMD) of the brachial artery, calculated as FMD AUC for 0-180 minutes (change from baseline) | Area under curve for FMD for three hours (0, 30, 60, 90, 120, 180 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Nitrite/Nitrate (NOx) | NOx AUC for 0-180 minutes | Area under curve for nitrite/nitrate for three hours (0, 30, 60, 90, 120, 180 min) (change from baseline) |
| Plasma Glucose | Plasma glucose concentration from 0-180 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard S Bruno, PhD, RD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25520374 | Background | Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available. | |
| 11176766 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Glucose, Then Whey Protein, Then Sodium Caseinate, Then Milk | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG001 | Glucose, Then Milk, Then Sodium Caseinate, Then Whey Protein | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG002 | Glucose, Then Sodium Caseinate, Then Milk, Then Whey Protein | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG003 | Glucose, Then Whey Protein, Then Milk, Then Sodium Caseinate | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG004 | Glucose, Then Sodium Caseinate, Then Whey Protein, Then Milk | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG005 | Milk, Then Glucose, Then Sodium Caseinate, Then Whey Protein | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG006 | Milk, Then Whey Protein, Then Glucose, Then Sodium Caseinate | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG007 | Milk, Then Whey Protein, Then Sodium Caseinate, Then Glucose | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG008 | Milk, Then Sodium Caseinate, Then Whey Protein, Then Glucose | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG009 | Milk, Then Glucose, Then Whey Protein, Then Sodium Caseinate | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG010 | Milk, Then Sodium Caseinate, Then Glucose, Then Whey Protein | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG011 | Whey Protein, Then Glucose, Then Sodium Caseinate, Then Milk | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG012 | Whey Protein, Then Glucose, Then Milk, Then Sodium Caseinate | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG013 | Whey Protein, Then Sodium Caseinate, Then Glucose, Then Milk | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG014 | Whey Protein, Then Milk, Then Sodium Caseinate, Then Glucose | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG015 | Whey Protein, Then Sodium Caseinate, Then Milk, Then Glucose | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG016 | Whey Protein, Then Milk, Then Glucose, Then Sodium Caseinate | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG017 | Sodium Caseinate, Then Glucose, Then Milk, Then Whey Protein | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG018 | Sodium Caseinate, Then Whey Protein, Then Milk, Then Glucose | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG019 | Sodium Caseinate, Then Milk, Then Glucose, Then Whey Protein | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG020 | Sodium Caseinate, Then Whey Protein, Then Glucose, Then Milk | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG021 | Sodium Caseinate, Then Milk, Then Whey Protein, Then Glucose | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| FG022 | Sodium Caseinate, Then Glucose, Then Whey Protein, Then Milk | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Vascular Endothelial Function | Flow mediated dilation (FMD) of the brachial artery, calculated as FMD AUC for 0-180 minutes (change from baseline) | Posted | Mean | Standard Error | %*min | Area under curve for FMD for three hours (0, 30, 60, 90, 120, 180 minutes) |
|
Participants were monitored for adverse events during the entirety of the study duration (~6 total weeks).
Participants completed a cross-over trial that examined blood vessel function and related biomarkers in response to a single controlled meal.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glucose | This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Bruno, PhD, RD | The Ohio State University | 6142925522 | bruno.27@osu.edu |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| D002364 | Caseins |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D008894 |
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| Glucose with Non-fat Milk | Other | Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. |
|
| Glucose with Whey Protein Isolate | Other | Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. |
|
| Glucose with Sodium Caseinate | Other | Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
|
| Area under the curve for glucose for three hours (0, 30, 60, 90, 120, 180 minutes) (change from baseline) |
| Malondialdehyde (MDA) | Plasma MDA measured as MDA AUC from 0-180 minutes | Area under curve for MDA for three hours (0, 30, 60, 90, 120, 150, 180 min.) (change from baseline) |
| Arginine (ARG) | Plasma arginine concentration, calculated as ARG AUC from 0-180 minutes | ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
| Asymmetric Dimethylarginine/Arginine (ADMA/ARG) | Plasma ADMA/arginine concentration, calculated as ADMA/ARG AUC from 0-180 minutes | ADMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
| Symmetric Dimethylarginine/Arginine (SDMA/ARG) | Plasma SDMA/arginine concentration, calculated as SDMA/ARG AUC from 0-180 minutes | SDMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
| Tetrahydrobiopterin/Dihydrobiopterin (BH4/BH2) | Plasma BH4/BH2 concentration, calculated as BH4/BH2 AUC from 0-180 minutes | Plasma BH4/BH2 concentration area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
| Insulin | Plasma insulin concentration, calculated as insulin AUC from 0-180 minutes | Insulin area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
| Cholecystokinin (CCK) | Plasma CCK concentration, calculated as CCK AUC from 0-180 minutes | CCK area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
| 8-isoprostaglandin-F2a | Plasma 8-isoprostaglandin-F2a concentration, calculated as 8-isoprostaglandin-F2a AUC from 0-180 minutes | 8-isoprostaglandin-F2a area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
| 8-isoprostaglandin-F2a/Arachidonic Acid | Plasma 8-isoprostaglandin-F2a/Arachidonic acid concentration, calculated as 8-isoprostaglandin-F2a/Arachidonic acid AUC from 0-180 minutes | 8-isoprostaglandin-F2a/Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
| Arachidonic Acid | Arachidonic acid concentration, calculated as Arachidonic acid AUC from 0-180 minutes | Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
| 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. |
| 26024056 | Background | Ballard KD, Bruno RS. Protective role of dairy and its constituents on vascular function independent of blood pressure-lowering activities. Nutr Rev. 2015 Jan;73(1):36-50. doi: 10.1093/nutrit/nuu013. |
| 23966328 | Background | Ballard KD, Mah E, Guo Y, Pei R, Volek JS, Bruno RS. Low-fat milk ingestion prevents postprandial hyperglycemia-mediated impairments in vascular endothelial function in obese individuals with metabolic syndrome. J Nutr. 2013 Oct;143(10):1602-10. doi: 10.3945/jn.113.179465. Epub 2013 Aug 21. |
| 30412905 | Background | McDonald JD, Mah E, Chitchumroonchokchai C, Dey P, Labyk AN, Villamena FA, Volek JS, Bruno RS. Dairy milk proteins attenuate hyperglycemia-induced impairments in vascular endothelial function in adults with prediabetes by limiting increases in glycemia and oxidative stress that reduce nitric oxide bioavailability. J Nutr Biochem. 2019 Jan;63:165-176. doi: 10.1016/j.jnutbio.2018.09.018. Epub 2018 Sep 25. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Waist Circumference | Mean | Standard Deviation | cm |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Fasting Glucose | Mean | Standard Deviation | mmol/L |
|
| Total Cholesterol | Mean | Standard Deviation | mmol/L |
|
| OG002 | Glucose With Whey Protein Isolate | This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. |
| OG003 | Glucose With Sodium Caseinate | This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. |
|
|
| Secondary | Nitrite/Nitrate (NOx) | NOx AUC for 0-180 minutes | Posted | Mean | Standard Error | umol/L*min | Area under curve for nitrite/nitrate for three hours (0, 30, 60, 90, 120, 180 min) (change from baseline) |
|
|
|
| Secondary | Plasma Glucose | Plasma glucose concentration from 0-180 minutes | Posted | Mean | Standard Error | mg/dL*min | Area under the curve for glucose for three hours (0, 30, 60, 90, 120, 180 minutes) (change from baseline) |
|
|
|
| Secondary | Malondialdehyde (MDA) | Plasma MDA measured as MDA AUC from 0-180 minutes | Posted | Mean | Standard Error | umol/L*min | Area under curve for MDA for three hours (0, 30, 60, 90, 120, 150, 180 min.) (change from baseline) |
|
|
|
| Secondary | Arginine (ARG) | Plasma arginine concentration, calculated as ARG AUC from 0-180 minutes | Posted | Mean | Standard Error | umol/L*min | ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
|
|
|
| Secondary | Asymmetric Dimethylarginine/Arginine (ADMA/ARG) | Plasma ADMA/arginine concentration, calculated as ADMA/ARG AUC from 0-180 minutes | Posted | Mean | Standard Error | (nmol/L)/(umol/L)*min | ADMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
|
|
|
| Secondary | Symmetric Dimethylarginine/Arginine (SDMA/ARG) | Plasma SDMA/arginine concentration, calculated as SDMA/ARG AUC from 0-180 minutes | Posted | Mean | Standard Error | (nmol/L)/(umol/L)*min | SDMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
|
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| Secondary | Tetrahydrobiopterin/Dihydrobiopterin (BH4/BH2) | Plasma BH4/BH2 concentration, calculated as BH4/BH2 AUC from 0-180 minutes | Posted | Mean | Standard Error | ratio*min | Plasma BH4/BH2 concentration area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
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| Secondary | Insulin | Plasma insulin concentration, calculated as insulin AUC from 0-180 minutes | Posted | Mean | Standard Error | uIU/mL*min | Insulin area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
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| Secondary | Cholecystokinin (CCK) | Plasma CCK concentration, calculated as CCK AUC from 0-180 minutes | Posted | Mean | Standard Error | pmol/L*min | CCK area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
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| Secondary | 8-isoprostaglandin-F2a | Plasma 8-isoprostaglandin-F2a concentration, calculated as 8-isoprostaglandin-F2a AUC from 0-180 minutes | Posted | Mean | Standard Error | pg/mL*min | 8-isoprostaglandin-F2a area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
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| Secondary | 8-isoprostaglandin-F2a/Arachidonic Acid | Plasma 8-isoprostaglandin-F2a/Arachidonic acid concentration, calculated as 8-isoprostaglandin-F2a/Arachidonic acid AUC from 0-180 minutes | Posted | Mean | Standard Error | (pg/mL)/(ug/mL)*min | 8-isoprostaglandin-F2a/Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
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| Secondary | Arachidonic Acid | Arachidonic acid concentration, calculated as Arachidonic acid AUC from 0-180 minutes | Posted | Mean | Standard Error | ug/mL*min | Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline) |
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| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Glucose With Non-fat Milk | This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes. | 0 | 23 | 0 | 23 |
| EG002 | Glucose With Whey Protein Isolate | This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes. | 0 | 23 | 0 | 23 |
| EG003 | Glucose With Sodium Caseinate | This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes. | 0 | 23 | 0 | 23 |
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010750 | Phosphoproteins |