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临床试验/NCT03659695
NCT03659695终止不适用

Cardioprotective Effects of Freeze Dried Grape Powder Supplementation on Blood Pressure and Plasma Lipids/Lipoproteins: A Pilot Study

University of Arizona2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
16
试验地点
2
主要终点
LDL-C/non-HDL-C

研究概览

简要总结

Whole food-based dietary interventions have the potential to promote cardiometabolic health via multiple mechanisms, including improvements in blood pressure, bad cholesterol, and other markers of metabolic health. Previous research suggests that grapes have the potential to promote optimal cardiometabolic function by reducing LDL-C, but it remains unclear whether there is a dose-response relationship. Moreover, few studies have evaluated effects on vascular health following daily grape consumption. We propose to examine the effects of 6-8 weeks of supplementation with freeze dried grape powder (69 g/d; ~three ¾ cup servings) compared to a control powder without grapes on: 1) bad cholesterol and blood pressure and 2) other measures of cardiometabolic health, including glucose and insulin. We will enroll overweight (BMI 25-36 kg/m2) but otherwise healthy adults with moderately elevated LDL-C (>115 mg/dL for women and >130 mg/dL for men) and/or blood pressure of120-159/80-99 mm Hg. This will optimize the potential for observing significant changes in these measures of health. We will recruit 20 eligible participants with the expectation that at least 15 will complete the study. The placebo-controlled, crossover study design will allow for a direct comparison of effects within the same participant. We anticipate that the bioactive components of grapes will promote cardiometabolic health via changes in LDL-C and blood pressure. Results from the proposed study would help to clarify how daily grape consumption might promote health and would provide further support for incorporating whole, unprocessed fruit in a healthy dietary pattern.

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
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI of 25-36 kg/m2
  • At least one of the following:
  • LDL-C above 115 mg/dL (women) or above 130 mg/dL (men)
  • Systolic blood pressure of 120-159 mmHg
  • Diastolic blood pressure of 80-99 mmHg

排除标准

  • Allergies to grapes
  • History of CVD, blood pressure ≥ 160/100 mmHg, kidney disease, diabetes, or inflammatory diseases such as GI disorders and rheumatoid arthritis
  • Use of medications/supplements for elevated lipids, blood pressure, or glucose
  • Chronic use of non-steroidal anti-inflammatory or immunosuppressant drugs
  • Conditions requiring chronic use of steroids

结局指标

主要结局

LDL-C/non-HDL-C

时间窗: 6-8 weeks

Brachial and central blood pressure

时间窗: 6-8 weeks

systolic and diastolic pressures

次要结局

  • Other lipids and lipoproteins(6-8 weeks)
  • Glucose(6-8 weeks)
  • Augmentation Index(6-8 weeks)
  • Pulse Wave Velocity (PWV)(6-8 weeks)
  • Insulin(6-8 weeks)

研究者

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

Ann Skulas-Ray

Assistant Professor of Nutritional Sciences

University of Arizona

研究点 (2)

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