Exercise Tolerance (Measured in Minutes)Phase 1NCT01610024
Northern Board Beet Breathlessness Trial
A Phase 1 study testing Beetroot Juice in people with Exercise Tolerance (Measured in Minutes), run by Northern Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
Hypothesis: Beetroot juice increases the exercise tolerance of patients with chronic lung disease. Using the already established pulmonary rehabilitation model, we aim to split the group of 8 into 2 groups, each group taking 500ml of beetroot juice 24 hours before there class on alternate (differing) weeks to see if… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Exercise Tolerance (Measured in Minutes)
- What is being tested?
- Beetroot Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to Nov 2013
- Phase
- Phase 1
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Already planned to attend the pulmonary rehabilitation class
Who cannot join
- Angina Prescribed regular nitrates, a resting heart rate >100bpm, a resting blood pressure <110 systolic, postural hypotension, prescribed PDE5 inhibitors.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Antrim Area Hospital
Antrim, County Antrim, BT41 2RL
Wendy Anderson, MBBCh, 00442894424000, wendy.anderson@northerntrust.hscni.net
Wendy Anderson, MBBCh
About this study
Hypothesis: Beetroot juice increases the exercise tolerance of patients with chronic lung disease.
Using the already established pulmonary rehabilitation model, we aim to split the group of 8 into 2 groups, each group taking 500ml of beetroot juice 24 hours before there class on alternate (differing) weeks to see if it improves their overall exercise tolerance.
- Conditions
- Exercise Tolerance (Measured in Minutes)
- Being tested
- Beetroot Juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot JuiceDietary supplement
Give subjects 500ml beetroot juice in the 24 hour period prior to class begins. They will receive this during 3 of the 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Beetroot | Active comparator | Not described Receives: Dietary Supplement: Beetroot Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Tolerance
Measuring incremental change in exercise tolerance between weeks of beetroot consumption and weeks of no beetroot consumption
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Tolerance (Measured in Minutes)Studies 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 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Health and Social Care Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Wendy Anderson, Northern Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610024
- Sponsor's protocol ID
- RDF001
- Status last verified
- Jun 2013
- First submitted
- 30 May 2012
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Northern Board Beet Breathlessness Trial
- ClinicalTrials.gov ID
- NCT01610024
- Acronym / sponsor ID
- RDF001
- Conditions
- Exercise Tolerance (Measured in Minutes)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Northern Health and Social Care TrustOther government
- Study start
- Aug 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 1 Jun 2012 (estimated)
- 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.
Hypothesis: Beetroot juice increases the exercise tolerance of patients with chronic lung disease.
Using the already established pulmonary rehabilitation model, we aim to split the group of 8 into 2 groups, each group taking 500ml of beetroot juice 24 hours before there class on alternate (differing) weeks to see if it improves their overall exercise tolerance.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Beetroot | Active comparator | Dietary Supplement: Beetroot Juice |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Already planned to attend the pulmonary rehabilitation class
Key exclusion criteria (1 listed)
- Angina Prescribed regular nitrates, a resting heart rate >100bpm, a resting blood pressure <110 systolic, postural hypotension, prescribed PDE5 inhibitors.
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 JuiceGive subjects 500ml beetroot juice in the 24 hour period prior to class begins. They will receive this during 3 of the 6 weeks | Dietary supplement | Beetroot |
Primary outcome
Exercise Tolerance
Time frame: 6 weeks
Measuring incremental change in exercise tolerance between weeks of beetroot consumption and weeks of no beetroot consumption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
Related trials for Exercise Tolerance (Measured in Minutes)
Not yet recruiting
High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation
Heart Failure, Exercise Tolerance (Measured in Minutes)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Beetroot Juice in people with Exercise Tolerance (Measured in Minutes), run by Northern Health and Social Care Trust 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jun 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wendy Anderson, MBBCh (0044 2894424000, Wendy.Anderson@northerntrust.hscni.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Tolerance (time frame: 6 weeks). 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 26 Jun 2013.