An Investigation Into the Feasibility of Beetroot Juice Supplementation in People Living With Alzheimer's Disease.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-85
SponsorUniversity of the West of Scotland

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Beetroot juice

    Dietary supplement

    Participants will take a concentrated beetroot juice shot (70ml) twice daily for 1-week. Each shot contains 400mg of dietary nitrate (800mg per day).

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Beetroot juice supplementationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of a beetroot juice intervention in people living with Alzheimer's disease

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.

Time frame
From enrolment to the post-intervention testing 8-days later.

Secondary outcomes

1

Changes to oral microbiome pre to post intervention

An oral swab will collect bacteria from the tongue to analyse changes in the relative abundance of bacteria (%). Particular interest will be paid to pathogenic and nitrate reducing bacteria. Higher abundances of pathogenic bacteria and lower abundances of nitrate reducing bacteria indicate poorer oral health.

Time frame
From enrolment to the post-intervention testing 8-days later.
2

Changes to cognitive function pre and post intervention

Cognitive function will be assessed pre and post-intervention through the use of Montreal Cognitive Assessment. A different version of the questionnaire will be completed pre and post. Higher scores indicate better cognitive performance.

Time frame
From enrolment to the post-intervention testing 8-days later.
3

Changes to nitric oxide metabolism

Blood will be collected and analysed for arginine levels (µM). Higher nitric oxide levels can mean better health however, the inclusion of iNOS measurements is to determine the source of the nitric oxide i.e. whether it's inflammatory based, or health based.

Time frame
From enrolment to the post-intervention testing 8-days later.
4

Changes to nitric Oxide metabolism

Saliva and blood will be collected and analysed for nitric oxide levels (µM). Higher nitric oxide levels can mean better health however, the inclusion of iNOS measurements is to determine the source of the nitric oxide i.e. whether it's inflammatory based, or health based.

Time frame
From enrolment to the post-intervention testing 8-days later.

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: