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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. Further controversial is the extent to which dietary fat derived from dairy foods regulate the risk of CVD. The health benefits of dairy on CVD risk are at least partly attributed to its ability to limit PPH and resulting PPH-mediated responses leading to vascular dysfunction. This provides rationale to investigate full-fat containing dairy as a dietary strategy to reduce PPH and risk for heart disease. The objective of this project is to define the extent to which full-fat dairy milk compared to non-fat dairy milk protects against PPH-induced vascular dysfunction by reducing oxidative stress responses that limit nitric oxide bioavailability to the vascular endothelium in adults with prediabetes.
This study consists of three, 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, and 3. oral glucose challenge in combination with whole milk. 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. |
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| Glucose with Whole 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucose | Other | Following baseline measurements, participants will consume a 75 g glucose solution within five minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 curve of FMD for three hours (0, 30, 60, 90, 120, 150, and 180 min) |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker of Nitric Oxide Homeostasis (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) |
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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 Glucose +Non-fat Milk, Then Glucose + Whole Milk | Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. |
| FG001 | Glucose, Then Glucose + Whole Milk, Then Glucose +Non-fat Milk | Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes. |
| FG002 | Glucose +Non-fat Milk, Then Glucose + Whole Milk, Then Glucose | Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. |
| FG003 | Glucose +Non-fat Milk, Then Glucose, Then Glucose + Whole Milk | Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. |
| FG004 | Glucose + Whole Milk, Then Glucose, Then Glucose +Non-fat Milk | Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes. |
| FG005 | Glucose + Whole Milk, Then Glucose +Non-fat Milk, Then Glucose | Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants who were randomized to receive either Glucose, Glucose + Whole Fat Milk, or Glucose + Non-fat Milk. All participants received all three treatments in a randomized order. Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. Glucose + Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. Glucose + Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk 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) 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) | Posted | Mean | Standard Error | %*min | Area under curve of FMD for three hours (0, 30, 60, 90, 120, 150, and 180 min) |
|
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. The risk for all-cause mortality relating to the study is perceived to be zero.
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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, Then Glucose +Non-fat Milk, Then Glucose + Whole Milk | Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2015 | Nov 20, 2018 | Prot_SAP_000.pdf |
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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 |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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| Glucose with Whole Fat Milk | Other | Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of whole fat milk within five minutes. |
|
| 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. |
|
| Area under curve of nitrite/nitrate for three hours (0, 30, 60, 90, 120, 150, and 180 min) |
| Glucose | Glucose concentrations evaluated on the basis as change from baseline to calculate glucose area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in glucose from 0 min to 180 min (i.e., AUC (glucose 0 min- 0 min, glucose 30 min-0 min, glucose 60 min-0 min, etc) | Area under curve of glucose for three hours (0, 30, 60, 90, 120, 150, and 180 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) | Area under curve of MDA for three hours (0, 30, 60, 90, 120, 150, 180 min) |
| 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 | Result | 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 | mg/dL |
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| Total Cholesterol | Mean | Standard Deviation | mg/dL |
|
| Carotid Artery Intima Media Thickness (cIMT) (left) | cIMT was assessed as a potential co-variate by measuring cIMT using ultrasonography | Mean | Standard Deviation | mm |
|
| Carotid Artery Intima Media Thickness (cIMT) (right) | cIMT was assessed as a potential co-variate by measuring cIMT using ultrasonography | Mean | Standard Deviation | mm |
|
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 Whole Fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of whole fat milk within five minutes. |
| OG002 | 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. |
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| Secondary | Biomarker of Nitric Oxide Homeostasis (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) | Posted | Mean | Standard Error | umol/L*min | Area under curve of nitrite/nitrate for three hours (0, 30, 60, 90, 120, 150, and 180 min) |
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| 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) | Posted | Mean | Standard Error | mg/dL*min | Area under curve of glucose for three hours (0, 30, 60, 90, 120, 150, and 180 min) |
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|
| 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) | Posted | Mean | Standard Error | umol/L*min | Area under curve of MDA for three hours (0, 30, 60, 90, 120, 150, 180 min) |
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|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Glucose, Then Glucose + Whole Milk, Then Glucose +Non-fat Milk | Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Glucose +Non-fat Milk, Then Glucose + Whole Milk, Then Glucose | Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | Glucose +Non-fat Milk, Then Glucose, Then Glucose + Whole Milk | Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG004 | Glucose + Whole Milk, Then Glucose, Then Glucose +Non-fat Milk | Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG005 | Glucose + Whole Milk, Then Glucose +Non-fat Milk, Then Glucose | Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D004700 | Endocrine System Diseases |