N/A
N=22
Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Fat
Prediabetes
Bottom Line
View on ClinicalTrials.gov: NCT02482610 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Vascular Endothelial Function — -195.9; -6.181; -5.629 %*min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Glucose (Other); Glucose with Whole Fat Milk (Other); Glucose with Non-fat Milk (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vascular Endothelial Function |
-195.9; -6.181; -5.629 | — |
| SECONDARY Biomarker of Nitric Oxide Homeostasis (NOx) |
-2229; -1240; -1221 | — |
| SECONDARY Glucose |
6259; 4481; 3408 | — |
| SECONDARY Oxidative Stress Biomarker (Malondialdehyde; MDA) |
54.9; 25.78; 31.3 | — |
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. 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.
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 (NCT02482610). 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.