University of the West of Scotland
Glasgow, Lanarkshire, G72 0LH, United Kingdom
NCT Number: NCT07258004
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
Trial opening soon.
Get Notified65 year–85 year
All sexes
Interventional
Not applicable
Glasgow, Lanarkshire, G72 0LH, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will take a concentrated beetroot juice shot (70ml) twice daily for 1-week. Each shot contains 400mg of dietary nitrate (800mg per day).
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.
Time frame: From enrolment to the post-intervention testing 8-days later.
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.
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.
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.
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.
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.
Time frame: From enrolment to the post-intervention testing 8-days later.
Blood will be collected to analyse inducible nitric oxide synthase (iNOS) activity (relative fold change). Higher iNOS activity indicates greater levels of inflammation.
Time frame: From enrolment to the post-intervention testing 8-days later.
Pulse wave analysis (augmentation index %) will be measured with lower scores considered better.
Time frame: From enrolment to the post-intervention testing 8-days later.
Body mass index (kg/m²) will be calculated by measuring height (m) and weight (kg).
Time frame: From enrolment to the post-intervention testing 8-days later.
Blood pressure (mmHg) will be measured with 120/80 considered normal.
Time frame: From enrolment to the post-intervention testing 8-days later.
Exercise capacity will be measured with a 2-minute step in place test (more steps indicates a higher fitness level).
Time frame: From enrolment to the post-intervention testing 8-days later.
The International Physical Activity Questionnaire will be used to determine whether their physical activity levels change over the course of the intervention.
Time frame: From enrolment to the post-intervention testing 8-days later.
Quality of life will be measured using Dementia Quality of Life questionnaire (DEMQOL). Higher scores indicate a higher quality of life.
Contact information is provided by the study sponsor or research team.
University of the West of Scotland
Other
OMNI Brain Health - An Investigation Into the Feasibility of Beetroot Juice Supplementation in People Living With Alzheimer's Disease.
Acronym: OMNI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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