Alzheimer's DiseaseOMNINCT07258004
An Investigation Into the Feasibility of Beetroot Juice Supplementation in People Living With Alzheimer's Disease.
A study testing Beetroot juice in people with Alzheimer's Disease, run by University of the West of Scotland at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Beetroot juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rachel Kimble contact
United Kingdom1 site
University of the West of Scotland
Glasgow, Lanarkshire, G72 0LH
Scott N Findlay, +447909159194, scott.findlay@uws.ac.uk
Rachel Kimble, Rachel.Kimble@uws.ac.uk
About this study
Official title: OMNI Brain Health - An Investigation Into the Feasibility of Beetroot Juice Supplementation in People Living With Alzheimer's Disease.
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?
Read more
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
Read the detailed description
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.
- Conditions
- Alzheimer's Disease
- Being tested
- Beetroot juice
- Keywords
- Nitric oxide, Dementia, Alzheimer's disease, Oral microbiome, Dietary nitrate, Beetroot juice
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juiceDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| Beetroot juice supplementation | Experimental | Not described Receives: Dietary Supplement: Beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrolment to the post-intervention testing 8-days later.
Secondary outcomes (12)
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.
Measured: From enrolment to the post-intervention testing 8-days later.
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.
Measured: From enrolment to the post-intervention testing 8-days later.
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.
Measured: From enrolment to the post-intervention testing 8-days later.
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.
Measured: From enrolment to the post-intervention testing 8-days later.
Changes to nitric oxide metabolism
Blood will be collected for arginase activity (µmol/min/mg protein). Higher arginase activity could 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.
Measured: From enrolment to the post-intervention testing 8-days later.
Changes to nitric oxide metabolism
Blood will be collected to analyse inducible nitric oxide synthase (iNOS) activity (relative fold change). Higher iNOS activity indicates greater levels of inflammation.
Measured: From enrolment to the post-intervention testing 8-days later.
Changes in cardiovascular health pre to post intervention
Pulse wave analysis (augmentation index %) will be measured with lower scores considered better.
Measured: From enrolment to the post-intervention testing 8-days later.
Change in body mass index pre to post intervention
Body mass index (kg/m²) will be calculated by measuring height (m) and weight (kg).
Measured: From enrolment to the post-intervention testing 8-days later.
Changes in blood pressure pre to post intervention
Blood pressure (mmHg) will be measured with 120/80 considered normal.
Measured: From enrolment to the post-intervention testing 8-days later.
Changes in exercise capacity pre to post intervention.
Exercise capacity will be measured with a 2-minute step in place test (more steps indicates a higher fitness level).
Measured: From enrolment to the post-intervention testing 8-days later.
Changes in exercise levels pre to post intervention.
The International Physical Activity Questionnaire will be used to determine whether their physical activity levels change over the course of the intervention.
Measured: From enrolment to the post-intervention testing 8-days later.
Changes to quality of life pre to post intervention.
Quality of life will be measured using Dementia Quality of Life questionnaire (DEMQOL). Higher scores indicate a higher quality of life.
Measured: From enrolment to the post-intervention testing 8-days later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study startMar 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the West of Scotland
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lanarkshire
- Responsible party
- Principal investigator, Scott Nicol Findlay, University of the West of Scotland
- Investigators
- Rachel Kimble, Study director, University of the West of Scotland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258004
- Sponsor's protocol ID
- OMNI Feasibility trial
- Acronym
- OMNI
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data from this feasibility trial will not be shared due to the small sample size and the sensitive nature of the data collected from participants with Alzheimer's disease. Sharing the data could risk participant re-identification and compromise privacy.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OMNI Brain Health - An Investigation Into the Feasibility of Beetroot Juice Supplementation in People Living With Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT07258004
- Acronym / sponsor ID
- OMNI / OMNI Feasibility trial
- Conditions
- Alzheimer's Disease
- Keywords
- Nitric oxide, Dementia, Alzheimer's disease, Oral microbiome, Dietary nitrate, Beetroot juice
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of the West of ScotlandUniversity, hospital or other
- Collaborators
- NHS Lanarkshire
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Beetroot juice supplementation | Experimental | Dietary Supplement: Beetroot juice |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beetroot juiceParticipants will take a concentrated beetroot juice shot (70ml) twice daily for 1-week. Each shot contains 400mg of dietary nitrate (800mg per day). | Dietary supplement | Beetroot juice supplementation |
Primary outcome
Feasibility of a beetroot juice intervention in people living with Alzheimer's disease
Time frame: 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.
12 secondary outcomes
Changes to oral microbiome pre to post intervention
Time frame: From enrolment to the post-intervention testing 8-days later.
Changes to cognitive function pre and post intervention
Time frame: From enrolment to the post-intervention testing 8-days later.
Changes to nitric oxide metabolism
Time frame: From enrolment to the post-intervention testing 8-days later.
Changes to nitric Oxide metabolism
Time frame: From enrolment to the post-intervention testing 8-days later.
Changes to nitric oxide metabolism
Time frame: From enrolment to the post-intervention testing 8-days later.
Changes to nitric oxide metabolism
Time frame: From enrolment to the post-intervention testing 8-days later.
Changes in cardiovascular health pre to post intervention
Time frame: From enrolment to the post-intervention testing 8-days later.
Change in body mass index pre to post intervention
Time frame: From enrolment to the post-intervention testing 8-days later.
Changes in blood pressure pre to post intervention
Time frame: From enrolment to the post-intervention testing 8-days later.
Changes in exercise capacity pre to post intervention.
Time frame: From enrolment to the post-intervention testing 8-days later.
Changes in exercise levels pre to post intervention.
Time frame: From enrolment to the post-intervention testing 8-days later.
Changes to quality of life pre to post intervention.
Time frame: From enrolment to the post-intervention testing 8-days later.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data from this feasibility trial will not be shared due to the small sample size and the sensitive nature of the data collected from participants with Alzheimer's disease. Sharing the data could risk participant re-identification and compromise privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Kimble contact
Rachel Kimble study director
University of the West of Scotland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot juice in people with Alzheimer's Disease, run by University of the West of Scotland at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott N Findlay (+447909159194, scott.findlay@uws.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a beetroot juice intervention in people living with Alzheimer's disease (time frame: From enrolment to the post-intervention testing 8-days later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.