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

University of the West of Scotland

Status: Begins enrollment this month

Conditions: Alzheimer's Disease

Treatments: Dietary Supplement: Beetroot juice

Study type: Interventional

Funder types: Other

Identifiers

NCT07258004

OMNI Feasibility trial

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Beetroot juice supplementation

Experimental group

Treatment:

Dietary Supplement: Beetroot juice