Chronic Obstructive Pulmonary Disease ModerateCOPDNCT03020862
Beetroot Juice - Effects on Performance in Chronic Obstructive Pulmonary Disease Patients
A study testing Dietary beetroot juice in people with Chronic Obstructive Pulmonary Disease Moderate, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose is to evaluate exercise performance in patients with Chronic Obstructive Pulmonary Disease (COPD) after supplementing with higher doses of dietary NO3-, compared to previous studies, as beetroot juice for seven days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Moderate
- What is being tested?
- Dietary beetroot juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2013to Aug 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate-severe Chronics Obstructive Pulmonary Disease (COPD) (FEV1 <80% of predicted).
Who cannot join
- Smoking,
- failure to complete physical testing,
- on-going participation in rehabilitation programs,
- pacemaker or use of nicotine products,
- oxygen mask,
- beta blockers,
- antibacterial mouthwash,
- chewing gum or stomach-neutralizing medicine during the intervention.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Sport Science, Department of Public Health, Aarhus University
Aarhus, 8000
About this study
The purpose is to evaluate exercise performance in patients with Chronic Obstructive Pulmonary Disease (COPD) after supplementing with higher doses of dietary NO3-, compared to previous studies, as beetroot juice for seven days. The secondary purpose is to evaluate oxygen consumption of submaximal cycling, amendments in blood pressure, and physical activity level.
Read the detailed description
The purpose is to evaluate exercise performance in patients with Chronic Obstructive Pulmonary Disease (COPD) using the 6-minute walk test (6MWT) after supplementing with higher doses of dietary NO3- compared to previous studies, as beetroot juice for seven days. The secondary purpose is to evaluate oxygen consumption of submaximal cycling, amendments in blood pressure, and physical activity level.
- Being tested
- Dietary beetroot juice
- Keywords
- Dietary nitrate, Physical performance, Blood pressure, Nitrite, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary beetroot juiceDietary supplement
Consumed as concentrated beetroot juice from James White Drinks England (Beet-it) and contained 300 mg dietary nitrate. Dose: 2x70 mL consumed twice a day for six days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo ---> Dietary beetroot | Experimental | Placebo was administrated in the first period of the cross-over trial, while the intervention beverage Dietary Beetroot juice was administrated in the second period of the trial.
The placebo: was an NO3- negligble drink from James White Drinks England (Beet-it), which was otherwise similar to the dietary beetroot juice in nutrient composition, smell and appearance. Dose: 2x70 mL consumed twice a day for six days.
Intervention beverage, Dietary beetroot juice:Consumed as beetroot juice from James White Drinks England (Beet-it) and contained 300 mg dietary nitrate. Dose: 2x70 mL consumed twice a day for six days. Receives: Dietary Supplement: Dietary beetroot juice |
| Dietary beetroot juice --> Placebo | Experimental | The intervention beverage Dietary beetroot juice was administrated in the first period of the cross-over trial, while placebo was administrated in the second period of the trail Intervention beverage, Dietary beetroot juice:Consumed as beetroot juice from James White Drinks England (Beet-it) and contained 300 mg dietary nitrate. Dose: 2x70 mL consumed twice a day for six days. The placebo: was an NO3- negligble drink from James White Drinks England (Beet-it), which was otherwise similar to the dietary beetroot juice in nutrient composition, smell and appearance. Dose: 2x70 mL consumed twice a day for six days. Receives: Dietary Supplement: Dietary beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical performance on 6-min walk test (6MWT)
Measured: 6 minutes
Secondary outcomes (4)
Blood Pressure
Measured: At baseline and 150 minutes after consumption of beverages
Plasma Nitrite concentration
Measured: Baseline, 150 and 210 minutes after consumption of beverages
Oxygen consumption during submaximal cycling
Measured: Two trials of 6 minutes duration (10 min break between trials)
Physical activity level
Measured all intervention days except on the day of testing
Measured: Six days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease ModerateStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mette Hansen, Principal investigator, Aarhus University, Department for Public Health, Section for Sport Sciene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020862
- Sponsor's protocol ID
- D2013A2014
- Acronym
- COPD
- Status last verified
- Jun 2014
- First submitted
- 11 Jan 2017
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beetroot Juice - Effects on Performance in Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT03020862
- Acronym / sponsor ID
- COPD / D2013A2014
- Keywords
- Dietary nitrate, Physical performance, Blood pressure, Nitrite, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Jan 2017 (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.
The purpose is to evaluate exercise performance in patients with Chronic Obstructive Pulmonary Disease (COPD) after supplementing with higher doses of dietary NO3-, compared to previous studies, as beetroot juice for seven days. The secondary purpose is to evaluate oxygen consumption of submaximal cycling, amendments in blood pressure, and physical activity level.
Detailed description
The purpose is to evaluate exercise performance in patients with Chronic Obstructive Pulmonary Disease (COPD) using the 6-minute walk test (6MWT) after supplementing with higher doses of dietary NO3- compared to previous studies, as beetroot juice for seven days. The secondary purpose is to evaluate oxygen consumption of submaximal cycling, amendments in blood pressure, and physical activity level.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo ---> Dietary beetroot | Experimental | Dietary Supplement: Dietary beetroot juicePlacebo was administrated in the first period of the cross-over trial, while the intervention beverage Dietary Beetroot juice was administrated in the second period of the trial. The placebo: was an NO3- negligble drink from James White Drinks England (Beet-it), which was otherwise similar to the dietary beetroot juice in nutrient composition, smell and appearance. Dose: 2x70 mL consumed twice a day for six days. Intervention beverage, Dietary beetroot juice:Consumed as beetroot juice from James White Drinks England (Beet-it) and contained 300 mg dietary nitrate. Dose: 2x70 mL consumed twice a day for six days. |
| Dietary beetroot juice --> Placebo | Experimental | Dietary Supplement: Dietary beetroot juiceThe intervention beverage Dietary beetroot juice was administrated in the first period of the cross-over trial, while placebo was administrated in the second period of the trail Intervention beverage, Dietary beetroot juice:Consumed as beetroot juice from James White Drinks England (Beet-it) and contained 300 mg dietary nitrate. Dose: 2x70 mL consumed twice a day for six days. The placebo: was an NO3- negligble drink from James White Drinks England (Beet-it), which was otherwise similar to the dietary beetroot juice in nutrient composition, smell and appearance. Dose: 2x70 mL consumed twice a day for six days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate-severe Chronics Obstructive Pulmonary Disease (COPD) (FEV1 <80% of predicted).
Key exclusion criteria (8 listed)
- Smoking,
- failure to complete physical testing,
- on-going participation in rehabilitation programs,
- pacemaker or use of nicotine products,
- oxygen mask,
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 |
|---|---|---|
| Dietary beetroot juiceConsumed as concentrated beetroot juice from James White Drinks England (Beet-it) and contained 300 mg dietary nitrate. Dose: 2x70 mL consumed twice a day for six days. | Dietary supplement | Dietary beetroot juice --> Placebo, Placebo ---> Dietary beetroot |
Primary outcome
Physical performance on 6-min walk test (6MWT)
Time frame: 6 minutes
4 secondary outcomes
Blood Pressure
Time frame: At baseline and 150 minutes after consumption of beverages
Plasma Nitrite concentration
Time frame: Baseline, 150 and 210 minutes after consumption of beverages
Oxygen consumption during submaximal cycling
Time frame: Two trials of 6 minutes duration (10 min break between trials)
Physical activity level
Time frame: Six 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 16 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Mette Hansen principal investigator
Aarhus University, Department for Public Health, Section for Sport Sciene
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary beetroot juice in people with Chronic Obstructive Pulmonary Disease Moderate, run by University of Aarhus at 1 site in Denmark.
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 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 16 Jan 2017. 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 Denmark. 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.
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?
Physical performance on 6-min walk test (6MWT) (time frame: 6 minutes). 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 16 Jan 2017.