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临床试验/NCT03522974
NCT03522974终止不适用

Effects of Freeze Dried Strawberry Powder Supplementation on Vascular Function, Blood Markers of Cardiovascular Risk, and the Gut Microbiome

University of Arizona1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2019年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
1
主要终点
Brachial and central blood pressure

研究概览

简要总结

Dietary interventions designed to promote health by increasing the consumption of particular health-promoting foods (e.g., strawberries) generally target blood pressure and LDL-C; however, CVD risk reduction may also be achieved via changes in emerging endpoints such as the gut microbiome. Previous research suggests that strawberries have the potential to reduce LDL-C, but it remains unclear whether there is a dose-response relationship. Moreover, few studies have evaluated effects on vascular health or characterized changes in the gut microbiome following daily strawberry consumption. Additionally, previous studies have largely been conducted among Caucasian populations. Given the demographics of the US, it is important to evaluate effects in study populations that include ethnicities that may have higher risk of type 2 diabetes and/or other CVD risk factors, such as Hispanics. This study aims to examine the effects of 4 weeks of supplementation with two doses of freeze dried strawberry powder (low dose: 13 g/d and high dose: 40 g/d) on: 1) LDL-C and blood pressure; 2) gut microbiome profile; and 3) other CVD and type 2 diabetes risk factors, including glucose, insulin, and inflammatory markers. Overweight (BMI 25-36 kg/m2) but otherwise healthy adults with moderately elevated LDL-C (>3.0 mmol/L) and/or prehypertension (120-159/80-99 mm Hg) will be enrolled. This will optimize the potential for observing significant benefits on these outcomes. 50 eligible participants will be recruited with the expectation that at least 40 will complete the study. The placebo-controlled, crossover study design will allow for a direct comparison of dose-response within the same participant. The investigators anticipate that the bioactive components of strawberries will reduce LDL-C and blood pressure, and modify the gut microbiome, with greater changes on the high dose. There is preliminary evidence that polyphenol-rich foods can modify gut microbiota profiles, but this would be the first study to characterize the effects of daily strawberry consumption. The investigators are uniquely placed at the University of Arizona to enroll a larger percentage of Hispanic participants, who are often under-represented in clinical nutritional research. Results from the proposed study will improve understanding of how strawberries might promote health, and could provide further support for the incorporation of whole freeze dried fruit in dietary guidelines.

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
是

入选标准

  • •At least one of the following:
  • •LDL-C above 3.0 mmol/L (116 mg/dL)
  • •Systolic blood pressure of 120-159 mmHg
  • •Diastolic blood pressure of 80-99 mmHg
  • •Total cholesterol below 6.2 mmol/L (240 mg/dL)
  • •Triglycerides below 350 mg/dL

排除标准

  • •Allergies to strawberries
  • •History of CVD, Stage II hypertension (BP ≥ 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

研究组 & 干预措施

Placebo

Placebo Comparator

40 g/d placebo powder

干预措施: Placebo powder (Dietary Supplement)

Strawberry powder (high dose)

Experimental

40 g/d freeze dried strawberry powder

干预措施: Strawberry powder (Dietary Supplement)

Strawberry powder (low dose)

Active Comparator

13 g/d freeze dried strawberry powder

干预措施: Strawberry powder (Dietary Supplement)

结局指标

主要结局

Brachial and central blood pressure

时间窗: 4-6- weeks

systolic and diastolic blood pressures

LDL-C/non-HDL-C

时间窗: 4-6 weeks

次要结局

  • Other lipids and lipoproteins(4-6 weeks)
  • Glucose(4-6 weeks)
  • Pulse Wave Velocity (PWV)(4-6 weeks)
  • Augmentation Index(4-6 weeks)
  • Insulin(4-6 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 (1)

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