OMNI Brain Health - An Investigation Into the Feasibility of Beetroot Juice Supplementation in People Living With Alzheimer's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of a beetroot juice intervention in people living with Alzheimer's disease
研究概览
简要总结
The goal of this clinical trial is to learn if taking a beetroot juice supplement will work in people living with Alzheimer's disease. The main questions it aims to answer are:
- Can people living with Alzheimer's disease realistically drink beetroot juice regularly (for example, is it easy to take, free from side effects and acceptable)?
- Does drinking beetroot juice twice a day improve health in people living with Alzheimer's disease?
Researchers will look at how you managed with the beetroot juice, as well as if there were any improvements in your health measures.
Participants will:
- Complete testing before and after the intervention for no more than 3 hours each time
- Complete a 1-day food diary before testing
- Take a beetroot juice supplementation twice daily for 1-week
- Keep a note of any problems with the beetroot juice
详细描述
Primary objectives:
To establish the feasibility of a beetroot juice supplement in people living with Alzheimer's disease (primary outcome). To establish whether a twice per day, 1-week beetroot juice intervention will induce changes in dementia related health outcomes (secondary outcomes).
Outline:
Participants will complete a 24-hour food diary prior to baseline testing before starting twice daily supplementation of beetroot juice shots for 7 days. Post-testing will be conducted on day 8 with a further 24-hour food diary having been completed prior to testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 65-85 years
- •Mild or Moderate Alzheimer's disease
- •Participants must be able to speak, read, and understand English to participate in this study.
- •To support adherence, participants are asked to have a carer, partner, friend, or family member available to assist with reminders to take the shots twice daily.
排除标准
- •Advanced or severe Alzheimer's Disease
- •Diagnosis of an additional neurological condition
- •Have used antibiotics in the last month
- •Use of mouthwash in the last month
- •Use of medication affecting nitrate metabolism (for example proton pump inhibitors, Isosorbide Mononitrate, Sildenafil or Glyceryl Trinitrate).
- •Unable to provide informed consent
- •Allergies to beetroot
- •Taking part in pharmacological trials
结局指标
主要结局
Feasibility of a beetroot juice intervention in people living with Alzheimer's disease
时间窗: From enrolment to the post-intervention testing 8-days later.
Participants will be supported by a carer, friend or family member to complete a semi-structured interview to assess how feasible the trial was. Questions will be based around adherence (e.g. was the beetroot juice taken consistently and at the right times), acceptability/safety (e.g. was the beetroot juice tolerable and would they consider doing it daily if the benefits were proven and were there any adverse effects) and data collection feasibility (e.g. how easy was it to collect and post saliva samples themselves and how much of a burden was the pre and post-testing). Simple Likert scales will also be used to assess acceptability of the beetroot juice.
次要结局
- Changes to oral microbiome pre to post intervention(From enrolment to the post-intervention testing 8-days later.)
- Changes to nitric oxide metabolism(From enrolment to the post-intervention testing 8-days later.)
- Changes to cognitive function pre and post intervention(From enrolment to the post-intervention testing 8-days later.)
- Change in body mass index pre to post intervention(From enrolment to the post-intervention testing 8-days later.)
- Changes to nitric Oxide metabolism(From enrolment to the post-intervention testing 8-days later.)
- Changes in cardiovascular health pre to post intervention(From enrolment to the post-intervention testing 8-days later.)
- Changes in blood pressure pre to post intervention(From enrolment to the post-intervention testing 8-days later.)
- Changes in exercise levels pre to post intervention.(From enrolment to the post-intervention testing 8-days later.)
- Changes in exercise capacity pre to post intervention.(From enrolment to the post-intervention testing 8-days later.)
- Changes to quality of life pre to post intervention.(From enrolment to the post-intervention testing 8-days later.)
研究者
Scott Nicol Findlay
Principal Investigator
University of the West of Scotland