Blood PressureNCT03473678
Dietary Nitrate and Healthy Older Adults
A study testing Nitrate-rich beetroot juice and Nitrate-depleted beetroot juice in people with Blood Pressure and Cognitive Change, run by University of Exeter at 1 site in United Kingdom.
Trial summary
This study investigates the influence of dietary nitrate supplementation on cardiovascular health and physical and cognitive performance in older adults. Participants will receive both a nitrate containing beetroot juice for 10 days and a nitrate depleted beetroot juice for 10 days Read more about this study
- Who is it for?
- Ages 70 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Cognitive Change, Functional Capacity
- What is being tested?
- Nitrate-rich beetroot juice and Nitrate-depleted beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Feb 2014to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 70 - 80 years of age
- male or female
Who cannot join
- involved in regular structured exercise
- receiving medication for:
- pulmonary conditions
- cardiovascular conditions
- metabolic conditions
- musculoskeletal conditions
- ulcerative colitis
- renal disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sport and Health Sciences, University of Exeter
Exeter, Devon, EX12LU
About this study
Official title: Influence of Dietary Nitrate Supplementation on Blood Pressure, Walking Economy, Functional Physical Capacity and Cognitive Function in Healthy Older Adults
This study investigates the influence of dietary nitrate supplementation on cardiovascular health and physical and cognitive performance in older adults. Participants will receive both a nitrate containing beetroot juice for 10 days and a nitrate depleted beetroot juice for 10 days
Read the detailed description
A recent exciting finding is that dietary nitrate supplementation (in the form of beetroot juice) appears to reduce the amount of oxygen needed to complete moderate intensity walking in healthy, young individuals. Nitrate is known to be converted in the body to nitric oxide (NO), a substance which reduces blood pressure and may affect the energy-producing mechanisms inside muscle cells. Exercise tolerance and muscle function typically declines with age and nitrate supplementation therefore may help improve cardiovascular health and the ability to carry out low-intensity daily activities in aging populations. The purpose of this study is to see if healthy, elderly individuals benefit from beetroot juice intake similarly to the effects seen in young adults. If this is indeed the case, then it may suggest that dietary supplementation with a relatively cheap, widely available, and natural food product may improve the ability of healthy elderly individuals to undergo everyday tasks and ultimately improve their quality of life.
- Being tested
- Nitrate-rich beetroot juice, Nitrate-depleted beetroot juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrate-rich beetroot juiceDietary supplement
concentrated beetroot juice
Nitrate-depleted beetroot juiceDietary supplement
concentrated beetroot juice
| Study group | Role | What they receive |
|---|---|---|
| Nitrate-rich beetroot juice | Active comparator | 2 x 70mL concentrated juice per day for 10 days Receives: Dietary Supplement: Nitrate-rich beetroot juice |
| Nitrate-depleted beetroot juice | Placebo comparator | 2 x 70mL concentrated juice per day for 10 days Receives: Dietary Supplement: Nitrate-depleted beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Change in blood pressure between interventions
Measured: 10 days
Secondary outcomes (5)
Oxygen cost of exercise
Change in oxygen consumption during exercise
Measured: 10 days
Serial Subtraction test
change in performance of the Serial Subtraction test
Measured: 10 days
Microbiome
change in oral microbiome measured by sequencing bacterial 16S rRNA genes
Measured: 10 days
Brain metabolism
change in brain metabolites measured measured by 1H MRS
Measured: 10 days
6 minute walk test
change in performance of 6 minute walk test
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start12 Feb 2014
- Primary completion28 May 2015
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew M Jones, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473678
- Sponsor's protocol ID
- 121964
- Status last verified
- Mar 2018
- First submitted
- 31 Jan 2018
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Dietary Nitrate Supplementation on Blood Pressure, Walking Economy, Functional Physical Capacity and Cognitive Function in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT03473678
- Acronym / sponsor ID
- 121964
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 12 Feb 2014 (actual)
- Primary completion
- 28 May 2015 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 22 Mar 2018 (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.
This study investigates the influence of dietary nitrate supplementation on cardiovascular health and physical and cognitive performance in older adults. Participants will receive both a nitrate containing beetroot juice for 10 days and a nitrate depleted beetroot juice for 10 days
Detailed description
A recent exciting finding is that dietary nitrate supplementation (in the form of beetroot juice) appears to reduce the amount of oxygen needed to complete moderate intensity walking in healthy, young individuals. Nitrate is known to be converted in the body to nitric oxide (NO), a substance which reduces blood pressure and may affect the energy-producing mechanisms inside muscle cells. Exercise tolerance and muscle function typically declines with age and nitrate supplementation therefore may help improve cardiovascular health and the ability to carry out low-intensity daily activities in aging populations. The purpose of this study is to see if healthy, elderly individuals benefit from beetroot juice intake similarly to the effects seen in young adults. If this is indeed the case, then it may suggest that dietary supplementation with a relatively cheap, widely available, and natural food product may improve the ability of healthy elderly individuals to undergo everyday tasks and ultimately improve their quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate-rich beetroot juice | Active comparator | Dietary Supplement: Nitrate-rich beetroot juice2 x 70mL concentrated juice per day for 10 days |
| Nitrate-depleted beetroot juice | Placebo comparator | Dietary Supplement: Nitrate-depleted beetroot juice2 x 70mL concentrated juice per day for 10 days |
Who may qualify
- Ages
- 70 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 70 - 80 years of age
- male or female
Key exclusion criteria (8 listed)
- involved in regular structured exercise
- receiving medication for:
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 |
|---|---|---|
| Nitrate-rich beetroot juiceconcentrated beetroot juice | Dietary supplement | Nitrate-rich beetroot juice |
| Nitrate-depleted beetroot juiceconcentrated beetroot juice | Dietary supplement | Nitrate-depleted beetroot juice |
Primary outcome
Blood pressure
Time frame: 10 days
Change in blood pressure between interventions
5 secondary outcomes
Oxygen cost of exercise
Time frame: 10 days
Serial Subtraction test
Time frame: 10 days
Microbiome
Time frame: 10 days
Brain metabolism
Time frame: 10 days
6 minute walk test
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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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. This study is not recruiting at the moment.
Andrew M Jones, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrate-rich beetroot juice and Nitrate-depleted beetroot juice in people with Blood Pressure and Cognitive Change, run by University of Exeter 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 2 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: finished, as of the sponsor's last update on 22 Mar 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 10 days). 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 22 Mar 2018.