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临床试验/NCT05514821
NCT05514821已完成不适用

Effects of Dietary Nitrate on Blood Pressure: Exploring the Repeatability and Inter-individual Variation in Responses

Newcastle University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Blood pressure of the brachial artery

研究概览

简要总结

Dietary nitrate supplementation, often in the form of beetroot juice, has been shown to lower blood pressure and could play a role in preventing or treating hypertension. However, it is currently unclear: a) how reproducible this response is within the same individual on different occasions, and b) whether there are genuine individual differences in the blood pressure lowering effects of dietary nitrate. This study will use a novel replicated cross-over design (2 x nitrate conditions, 2 x placebo conditions) to examine the reproducibility and inter-individual variability in the blood pressure lowering effects of dietary nitrate supplementation.

详细描述

The investigators will undertake a replicated cross-over randomised controlled trial (i.e., a study involving 2 x identical experimental conditions and 2 x identical control conditions), to explore the reproducibility of the blood pressure lowering effects of nitrate-rich beetroot juice, and to identify if there are genuine individual differences in the blood pressure-lowering effects of this supplement. Participants will be recruited via posters, email and social media, and interested individuals will be invited to attend the laboratory on 5 occasions.

Visit 1: Potential participants will be invited to attend a screening session at Newcastle University to identify if they are eligible to participate. They will have an opportunity to discuss the study with a researcher and will provide written consent. They will then complete a screening questionnaire and provide a measure of their height, weight and blood pressure. Eligible participants will be invited to attend 4 experimental trials (2 x nitrate-rich beetroot juice conditions, 2 x placebo conditions) over 2-3 weeks with a minimum of 3 days wash-out between visits. If individuals are ineligible to participate this will be explained to them and they will be thanked for their time.

Visits 2-5: On the day before the first trial, participants will be asked to record what they eat and then replicate this as closely as possible for all future visits. In the morning of each trial, participants will be asked to arrive at the laboratory between 7-9 am having fasted since 10 pm the night before. The participants will be required to rest for 10 minutes, after which a measure of their blood pressure will be obtained. Participants will then be provided with breakfast (a bowl of porridge) and 140 ml concentrated nitrate-rich (~12.5 mmol nitrate) or nitrate-depleted beetroot juice (~0 mmol nitrate). Participants will then be asked to sit in the laboratory for 2.5 hours, during which time they can read quietly or use a computer. The investigators will then obtain a further measure of their blood pressure and collect a blood sample from a vein in their arm via venepuncture, to measure markers of nitric oxide, a signalling molecule in the body which is thought to mediate the blood pressure lowering effects of nitrate-rich beetroot juice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Supplements will be administered double blind (participant and researcher blind) in identical bottles. They will be identical in smell, taste, texture and colour.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy male volunteers
  • Aged 18 - 45 years

排除标准

  • Aged less than 18 or more than 45 years old
  • Currently taking any medication or antibiotics
  • Attending general practitioner for a health problem or on a hospital waiting list
  • Currently taking part in another research study which could conflict with the requirements for this investigation
  • Regularly use antibacterial mouthwash and unwilling to stop using this throughout the study period
  • Current smoker
  • History of kidney, liver or cardiovascular disease
  • Have diabetes
  • Have a gastrointestinal disorder
  • Recent history (past 1 year) of cancer
  • Use of other dietary supplements e.g., pre and probiotics
  • Currently dieting
  • Have a known allergy to any components within the dietary supplement

结局指标

主要结局

Blood pressure of the brachial artery

时间窗: Immediately prior to supplementation and for 2.5 hours after supplementation

Blood pressure of the brachial artery

次要结局

  • Plasma nitrite concentrations(2.5 hours after supplementation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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