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临床试验/NCT03467061
NCT03467061已完成不适用

The Effect of Dietary Nitrate on the Oral Microbiota, Markers of Nitric Oxide Bioavailability and Cardiovascular Health in in Young and Older Adults

University of Exeter1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2018年1月10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
101
试验地点
1
主要终点
Quantity of nitrate -reducing bacteria

研究概览

简要总结

This study evaluates whether dietary manipulation of the oral microbiota modulates cardiovascular health through effects on nitric oxide bioavailability.

详细描述

Nitric oxide is an important molecule for human health because it controls blood flow and blood pressure. With aging, our ability to make nitric oxide gets worse and our blood pressure tends to increase. We can help the body produce more nitric oxide by supplementing the diet with vegetables, such as beetroot juice, which contains high amounts of nitrate. This has been shown to improve blood flow and blood pressure. The bacteria inside our mouths play an important role in helping convert the ingested nitrate to nitric oxide. The reason for this study is to find out whether there are differences in oral bacteria between young and older adults, and how the oral bacterial community and blood flow and blood pressure might change when diet is supplemented with natural, nitrate-rich beetroot juice and when we use antibacterial mouthwash. This study will help us understand how the bacteria inside our mouths might be useful for keeping us healthy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy young (18-30 yr) and older adults (65-80 yr)
  • •Male and female
  • •Willing to undergo the experiments as detailed in the informed consent documentation
  • •Willing and capable of providing written, informed consent.

排除标准

  • •Individuals receiving medication for pulmonary, cardiovascular, or metabolic conditions, ulcerative colitis or renal disease
  • •Having an active oral disease or dentures
  • •Having resting BP >140/90 mmHg
  • •Having used antibiotics within 3 months
  • •Lacking willingness or capacity to give informed consent.

研究组 & 干预措施

Nitrate-rich beetroot juice

Active Comparator

2 x 70mL concentrated juice per day for 14 days

干预措施: Nitrate-rich beetroot juice (Dietary Supplement)

Nitrate-depleted beetroot juice

Placebo Comparator

2 x 70mL concentrated juice per day for 14 days

干预措施: Nitrate-depleted beetroot juice (Dietary Supplement)

Antibacterial mouthwash

Other

2 x 10mL antibacterial mouthwash per day for 14 days

干预措施: Mouthwash (Other)

结局指标

主要结局

Quantity of nitrate -reducing bacteria

时间窗: 14 days

Change in total quantity of nitrate-reducing bacteria as measured by sequencing bacterial 16S rRNA genes

次要结局

  • Nitric oxide bioavailability - salivary nitrite(14 days)
  • Nitric oxide bioavailability - plasma nitrate(14 days)
  • Blood pressure(14 days)
  • Nitric oxide bioavailability - salivary nitrate(14 days)
  • Flow mediated dilation(14 days)
  • Nitric oxide bioavailability - plasma nitrite(14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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