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临床试验/NCT04781595
NCT04781595已完成不适用

Effect of Watermelon and Beetroot Products on Endothelial Function in Young and Older Adults

Universidade Federal do Rio de Janeiro1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年3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
已完成
入组人数
12
试验地点
1
主要终点
Flow-mediated dilation (FMD)

研究概览

简要总结

Cardiovascular disease is the main cause of death worldwide. Endothelial dysfunction is the first step to development of cardiovascular diseases. Endothelial dysfunction occurs due to reduction in nitric oxide, a molecule that plays an important role on vascular health. Due to important role of nitric oxide in endothelial function, several studies have evaluated the effect of its precursors, such as L-citrulline and nitrate on endothelial function parameters. The present study will evaluate the effect of L-citrulline and nitrate derived by watermelon and beetroot products, respectively, on endothelial function of young and older participants. Furthermore, we will evaluate the plasmatic amino acids, nitrate, glucose and insulin in response to ingestion of these products.

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
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for healthy young participants:
  • •Age between 18-35 years;
  • •Triglycerides ≤ 150 mg/dL
  • •HDL-cholesterol ≥ 50 mg/dL for women and ≥ 40 mg/dL for men;
  • •Waist circumference ≤ 102 cm for men and ≤ 88 cm for women).
  • •Inclusion Criteria for older people with cardiovascular risk:
  • •Age ≥ 60 years;
  • •Elevated triglycerides ≥150 mg/dL;
  • •Reduced HDL-cholesterol ≤ 50 mg/dL for women and ≤ 40 mg/dL for men;
  • •Elevated waist circumference ≥102 cm for men and ≥ 88 cm for women).

排除标准

  • •Elevated fasting glucose (≥100 mg/dL);
  • •Beetroot or watermelon allergy;
  • •Unwillingness to avoid beetroot or watermelon products during the entire study;
  • •Other chronic diseases (diabetes, liver disease, etc.) or acutely ill

研究组 & 干预措施

Beetroot

Active Comparator

Beetroot powder containing 8 mmol of nitrate.

干预措施: Beetroot (Dietary Supplement)

Watermelon + beetroot

Active Comparator

Watermelon powder containing 3 g of L-citrulline and Beetroot powder containing 8 mmol of nitrate.

干预措施: Watermelon + beetroot (Dietary Supplement)

Placebo

Placebo Comparator

Maltodextrin

干预措施: Placebo (Dietary Supplement)

Watermelon

Active Comparator

Watermelon powder containing 3 g of L-citrulline.

干预措施: Watermelon (Dietary Supplement)

结局指标

主要结局

Flow-mediated dilation (FMD)

时间窗: This measure will be evaluate 120 minutes after the nutritional intervention

Muscle oxygen saturation

时间窗: This measure will be evaluate 120 minutes after the nutritional intervention

Muscle oxygen saturation

时间窗: This measure will be evaluate 30 minutes after the nutritional intervention

Muscle oxygen saturation

时间窗: This measure will be evaluate 60 minutes after the nutritional intervention

Muscle oxygen saturation

时间窗: This measure will be evaluate 90 minutes after the nutritional intervention

Flow-mediated dilation (FMD)

时间窗: This measure will be evaluate 60 minutes after the nutritional intervention

Muscle oxygen saturation

时间窗: This measure will be evaluate before the nutritional intervention

Flow-mediated dilation (FMD)

时间窗: This measure will be evaluate before the nutritional intervention

次要结局

  • Plasmatic amino acids(This measure will be evaluate 120 minutes after the nutritional intervention)
  • Plasmatic insulin(This measure will be evaluate 120 min after the nutritional intervention)
  • Plasmatic glucose(This measure will be evaluate 120 min after the nutritional intervention)
  • Plasmatic amino acids(This measure will be evaluate before the nutritional intervention)
  • Plasmatic amino acids(This measure will be evaluate 30 minutes after the nutritional intervention)
  • Plasmatic amino acids(This measure will be evaluate 60 minutes after the nutritional intervention)
  • Plasmatic amino acids(This measure will be evaluate 90 minutes after the nutritional intervention)
  • Plasmatic glucose(This measure will be evaluate before the nutritional intervention)
  • Plasmatic glucose(This measure will be evaluate 30 min after the nutritional intervention)
  • Plasmatic glucose(This measure will be evaluate 60 min after the nutritional intervention)
  • Plasmatic glucose(This measure will be evaluate 90 min after the nutritional intervention)
  • Plasmatic insulin(This measure will be evaluate before the nutritional intervention)
  • Plasmatic insulin(This measure will be evaluate 30 min after the nutritional intervention)
  • Plasmatic insulin(This measure will be evaluate 60 min after the nutritional intervention)
  • Plasmatic insulin(This measure will be evaluate 90 min after the nutritional intervention)

研究者

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

Thiago Alvares

Principal Investigator

Universidade Federal do Rio de Janeiro

研究点 (1)

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