Investigating the effects of an eight-week intervention with beetroot on cognitive function and gut health
| ISRCTN | ISRCTN37389799 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37389799 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 1 |
| Sponsor | Newcastle University |
| Funder | G's Fresh Ltd. |
- Submission date
- 18/03/2019
- Registration date
- 03/04/2019
- Last edited
- 20/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
A reduction in blood flow to the brain is implicated in cognitive decline into older age, therefore the ability to improve blood perfusion to the brain in older adults is likely to impact on cognitive health in this population. Studies have demonstrated heightened regional blood perfusion in the brain following dietary nitrate consumption, which is present in beetroot and other vegetables. Dietary nitrate is converted to nitric oxide in the body, which helps to widen blood vessels in the body. Researchers have demonstrated acute improvements in cognitive performance after a dose of dietary nitrate, however the longer-term effects are currently poorly understood. Furthermore, supplementing with vegetables such as beetroot may increase dietary fibre intake over a prolonged period, leading to changes in gut microbiota. This can have a positive effect on gut health. This research proposal aims to investigate the link between dietary nitrate and cognitive performance and functional capacity in older adults, and assess the effect of dietary supplementation with beetroot on gut microbiota in this population. The main aim of this randomised, two-arm parallel trial is to assess cognitive test scores before and after intervention with beetroot in healthy older adults.
Who can participate?
Males and females between the ages of 60 and 80 years who are free of chronic illness.
What does the study involve?
Participants are randomly allocated to one of two interventions for a duration of eight weeks (150g beetroot plus one banana every second day or one banana every second day). Changes in cognitive test scores before, during and after the intervention period will be assessed. Participants will also be assessed for changes in gut microbiota and gut functioning, blood pressure, and functional capacity.
What are the possible benefits and risks of participating?
Participants may benefit from monetary reimbursement and from undergoing a body composition analysis. There are minor risks. Beetroot consumption can cause beeturia, discolouration of the urine, which is harmless and perfectly normal. Blood sampling can cause some minor bruising.
Where is the study run from?
NU-Food Research Centre, Newcastle University.
When is the study starting and how long is it expected to run?
22/01/2018 to 23/07/2018.
Who is funding the study?
1. G’s Fresh Ltd (UK)
2. Newcastle University (UK)
Who is the main contact?
Miss Tess Capper, t.capper2@newcastle.ac.uk
Professor Emma Stevenson, emma.stevenson@newcastle.ac.uk
Contact information
Public
M4.076 William Leech Building
Framlington Place
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
| Phone | 01912088264 |
|---|---|
| T.Capper@qub.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised two-armed open-label parallel intervention trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Investigating the effects of an eight-week intervention with whole beetroot on cognitive function, functional capacity and gut health in older adults |
| Study objectives | 1. Following beetroot consumption, cognitive test scores will improve 2. Following beetroot consumption, gut microbiota will show increased diversity and thus overall gut functioning will be improved |
| Ethics approval(s) | Approved 05/12/2017, Faculty of Medical Sciences Research Ethics Committee (Newcastle University Medical School, Framlington Place, Newcastle upon Tyne, NE2 4HH; 0191 208 6000; fmsethics@ncl.ac.uk) |
| Health condition(s) or problem(s) studied | Digestive health |
| Intervention | Eight weeks of supplementation with 150g whole cooked beetroot every second day plus one banana OR one banana every second day as a control. Participants were randomised online at randomization.com. Participants were allocated in a random order to receive one of two interventions above. Participants were asked to consume the intervention foods every second day for eight weeks and data was collected at baseline, at 5 weeks (midway) and at 9 weeks (end of study). |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Changes in cognitive test scores assessed by CogTrack online cognition programme at baseline, 5 and 9 weeks. |
| Key secondary outcome measure(s) |
1. Functional capacity measured by timed-up-and-go, grip strength and spirometry at baseline, 5 and 9 weeks |
| Completion date | 24/05/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Male or female between the ages of 60 and 80 years 2. In good health i.e. free of chronic illness 3. BMI greater than 20.0kg/m2 |
| Key exclusion criteria | 1. Vegetarianism 2. Vitamin or other dietary supplements – will be stopped for 4 weeks previous 3. Active cancer and any diagnosis of malignant cancer in the last 5 years 4. Excessive alcohol intake 5. Allergy or intolerance to the intervention food 6. Smoking 8. Epilepsy 9. Psychoactive medication 10. Mental health issues 11. Repetitive gastric reflux 12. Use of antibiotics in the last month 13. Drugs: corticosteroids, sildenafil, aspirin, anti-hypertensives (Ca2+ channel blockers, ACE inhibitors), diuretics, beta-blockers, antacids, anticoagulants, nitrate-derived agents, and anti-cholinergics. Those on statins and hormone replacement therapy must have had a stable dose over the past 3 months and no changes to dose are to occur during the study |
| Date of first enrolment | 03/01/2018 |
| Date of final enrolment | 05/03/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Agriculture Building
King's Road
Newcastle University
Newcastle upon Tyne
NE1 7RU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 16/01/2020 | 20/01/2020 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN37389799_BasicResults_16Jan20.pdf
- uploaded 20/01/2020
Editorial Notes
20/01/2020: The basic results of this trial have been uploaded as an additional file.
04/10/2019: The following changes have been made:
1. The public contact's details have been updated.
2. The intention to publish date has been changed from 15/04/2019 to 31/12/2019.
19/03/2019: Trial’s existence confirmed by IRB
