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临床试验/NCT02482610
NCT02482610已完成不适用

Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Fat

Ohio State University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Vascular Endothelial Function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • hemoglobin A1c 5.7-6.4%
  • non-dietary supplement user
  • no medications affecting vasodilation, inflammation, or energy metabolism
  • individuals having blood pressure <140/90 mmHg and total cholesterol <240 mg/dL

排除标准

  • unstable weight (±2 kg)
  • vegetarian or dairy allergy
  • alcohol intake >3 drinks/day or >10 drinks/week
  • ≥ 7 hours/week of aerobic activity

研究组 & 干预措施

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.

干预措施: Glucose with Whole Fat Milk (Other)

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.

干预措施: Glucose with Non-fat Milk (Other)

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.

干预措施: Glucose (Other)

结局指标

主要结局

Vascular Endothelial Function

时间窗: Area under curve of FMD for three hours (0, 30, 60, 90, 120, 150, and 180 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)

次要结局

  • Oxidative Stress Biomarker (Malondialdehyde; MDA)(Area under curve of MDA for three hours (0, 30, 60, 90, 120, 150, 180 min))
  • Glucose(Area under curve of glucose for three hours (0, 30, 60, 90, 120, 150, and 180 min))
  • Biomarker of Nitric Oxide Homeostasis (NOx)(Area under curve of nitrite/nitrate for three hours (0, 30, 60, 90, 120, 150, and 180 min))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Bruno

Professor and Principal Investigator

Ohio State University

研究点 (2)

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