N/A
N=23
Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Milk
Prediabetes
Bottom Line
View on ClinicalTrials.gov: NCT02482675 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Vascular Endothelial Function — -307; -34.8; -36.8; -110 %*min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Glucose (Other); Glucose with Non-fat Milk (Other); Glucose with Whey Protein Isolate (Other); Glucose with Sodium Caseinate (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vascular Endothelial Function |
-307; -34.8; -36.8; -110 | — |
| SECONDARY Nitrite/Nitrate (NOx) |
-1363; 347; -21; -57.2 | — |
| SECONDARY Plasma Glucose |
5828; 4032; 3340; 3640 | — |
| SECONDARY Malondialdehyde (MDA) |
66.5; 43.2; 46.4; 45.1 | — |
| SECONDARY Arginine (ARG) |
-3922; -1235; 195; -189 | — |
| SECONDARY Asymmetric Dimethylarginine/Arginine (ADMA/ARG) |
275; 55; 47; 25 | — |
| SECONDARY Symmetric Dimethylarginine/Arginine (SDMA/ARG) |
175; 31; 4; -17 | — |
| SECONDARY Tetrahydrobiopterin/Dihydrobiopterin (BH4/BH2) |
-47; 78; 171; 131 | — |
| SECONDARY Insulin |
8179.7; 8196.1; 8654.6; 8656.9 | — |
| SECONDARY Cholecystokinin (CCK) |
89.67; 422.87; 352.5; 519.94 | — |
| SECONDARY 8-isoprostaglandin-F2a |
2162.2; -824.14; -18.75; 229.14 | — |
| SECONDARY 8-isoprostaglandin-F2a/Arachidonic Acid |
10129; -1655.2; 2422.3; 3907.6 | — |
| SECONDARY Arachidonic Acid |
-2570; -1358.4; -2762.6; -2752.0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- hemoglobin A1c 5.7-6.4%
- non-dietary supplement user
- no medications affecting vasodilation, inflammation, or energy metabolism
- no CVD
- nonsmokers
- individuals having blood pressure 3 drinks/day or >10 drinks/week
- ≥7 hours/week of aerobic activity
Data sourced from ClinicalTrials.gov (NCT02482675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.