Chronic Obstructive Pulmonary DiseaseDISCONCT00435708
Effect of Increased Fruit and Vegetable Intake on Chronic Obstructive Pulmonary Disease (COPD)
A study testing 5 portions fruit and vegetables/day in people with Chronic Obstructive Pulmonary Disease, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
Chronic obstructive pulmonary disease (COPD) is the UK's fastest growing fatal disease and is estimated to cost the health service close to £1 billion every year. Around 80,000 people in Northern Ireland suffer from COPD. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- 5 portions fruit and vegetables/day
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2007to Sep 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- moderate to severe COPD (according to GOLD classification)
- oxygen saturation >= 92 KPa
- symptomatically stable
- habitually low fruit and vegetable intakes (<=2 portions daily)
- exercise limited by shortness of breath (rather than e.g. angina, arthritis)
Who cannot join
- diabetes
- taking antioxidant supplements or drugs
- oxygen saturation <8KPa
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's University Belfast
Belfast, Co.Antrim, BT12 6BJ
About this study
Official title: Effect of Increased Fruit and Vegetable Intake on Airway Inflammation and Oxidative Stress in Chronic Obstructive Pulmonary Disease (COPD)
Chronic obstructive pulmonary disease (COPD) is the UK's fastest growing fatal disease and is estimated to cost the health service close to £1 billion every year. Around 80,000 people in Northern Ireland suffer from COPD. COPD is clinically defined as a slowly progressive condition characterised by airflow limitation, which is largely irreversible. Chronic inflammation and oxidative stress are key components of the underlying pathological process resulting in airflow limitation. Dietary factors and nutrients that have antioxidant or anti-inflammatory properties are therefore of interest with respect to the aetiology of COPD. The antioxidant vitamins C, E and beta-carotene are all present in the lung milieu. Such antioxidants represent the lung's first line of defence against oxygen free radicals. Observational studies indicate that a low dietary intake of antioxidant nutrients, or foods rich in antioxidants (e.g. fruit and vegetables), is associated with decreased lung function and increased risk of COPD. To date, there have been no food-based dietary interventions investigating the effect of increased fruit and vegetable intake on COPD. The investigators propose to recruit people with mild to moderate COPD and low fruit and vegetable intakes (<=2 portions daily) and randomise them to one of two study arms for 12 weeks - either to increase fruit and vegetable consumption to at least 5 portions a day, or to follow their normal diet. Airway and systemic oxidative stress and inflammation will be assessed at baseline and post-intervention in order to determine if fruit and vegetables have the potential to alleviate the oxidative stress and airway inflammation associated with COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- 5 portions fruit and vegetables/day
- Keywords
- COPD, Fruit, Vegetables, Oxidative stress, Inflammation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 portions fruit and vegetables/dayBehavioural
Participants consume > = 5 portions fruit and veg per day
| Study group | Role | What they receive |
|---|---|---|
| Low fruit and vegetables | No intervention | Control - two or less portions fruit and vegetables/day |
| High fruit and vegetables | Experimental | 5 portions fruit and vegetables/day Receives: Behavioral: 5 portions fruit and vegetables/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Intake of Fruit and Vegetables (Number of Portions Per Day);
A series of 7-day diet histories were completed by each participant at weeks 0 and 12 in order to assess baseline diet and self-reported compliance with the intervention; average daily FV intake was then hand-counted from these records;
Measured: 12 weeks
Markers of Airway Inflammation in Induced Sputum - Sputum 8-isoprostane
Markers of Airway Inflammation in Induced Sputum - Sputum 8-isoprostane ng/ml
Measured: 12 Weeks
Secondary outcomes (1)
Biochemical Markers of Nutritional Status Plasma Vitamin C
Plasma vitamin C concentration umol/L
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle McKinley, Queen's University, Belfast
- Investigators
- Ian Young, MD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435708
- Sponsor's protocol ID
- Ref 200651
- Acronym
- DISCO
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2007
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Baldrick FR, Elborn JS, Woodside JV, Treacy K, Bradley JM, Patterson CC, Schock BC, Ennis M, Young IS, McKinley MC. Effect of fruit and vegetable intake on oxidative stress and inflammation in COPD: a randomised controlled trial. Eur Respir J. 2012 Jun;39(6):1377-84. doi: 10.1183/09031936.00086011. Epub 2011 Nov 16.
PubMed 22088966
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Increased Fruit and Vegetable Intake on Airway Inflammation and Oxidative Stress in Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00435708
- Acronym / sponsor ID
- DISCO / Ref 200651
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Fruit, Vegetables, Oxidative stress, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 15 Feb 2007 (estimated)
- Results
- Posted 31 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic obstructive pulmonary disease (COPD) is the UK's fastest growing fatal disease and is estimated to cost the health service close to £1 billion every year. Around 80,000 people in Northern Ireland suffer from COPD. COPD is clinically defined as a slowly progressive condition characterised by airflow limitation, which is largely irreversible. Chronic inflammation and oxidative stress are key components of the underlying pathological process resulting in airflow limitation. Dietary factors and nutrients that have antioxidant or anti-inflammatory properties are therefore of interest with respect to the aetiology of COPD. The antioxidant vitamins C, E and beta-carotene are all present in the lung milieu. Such antioxidants represent the lung's first line of defence against oxygen free radicals. Observational studies indicate that a low dietary intake of antioxidant nutrients, or foods rich in antioxidants (e.g. fruit and vegetables), is associated with decreased lung function and increased risk of COPD. To date, there have been no food-based dietary interventions investigating the effect of increased fruit and vegetable intake on COPD. The investigators propose to recruit people with mild to moderate COPD and low fruit and vegetable intakes (<=2 portions daily) and randomise them to one of two study arms for 12 weeks - either to increase fruit and vegetable consumption to at least 5 portions a day, or to follow their normal diet. Airway and systemic oxidative stress and inflammation will be assessed at baseline and post-intervention in order to determine if fruit and vegetables have the potential to alleviate the oxidative stress and airway inflammation associated with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low fruit and vegetables | No intervention | –Control - two or less portions fruit and vegetables/day |
| High fruit and vegetables | Experimental | Behavioral: 5 portions fruit and vegetables/day5 portions fruit and vegetables/day |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- moderate to severe COPD (according to GOLD classification)
- oxygen saturation >= 92 KPa
- symptomatically stable
- habitually low fruit and vegetable intakes (<=2 portions daily)
- exercise limited by shortness of breath (rather than e.g. angina, arthritis)
Key exclusion criteria (3 listed)
- diabetes
- taking antioxidant supplements or drugs
- oxygen saturation <8KPa
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 |
|---|---|---|
| 5 portions fruit and vegetables/dayParticipants consume > = 5 portions fruit and veg per day | Behavioural | High fruit and vegetables |
Primary outcome
Self-reported Intake of Fruit and Vegetables (Number of Portions Per Day);
Time frame: 12 weeks
A series of 7-day diet histories were completed by each participant at weeks 0 and 12 in order to assess baseline diet and self-reported compliance with the intervention; average daily FV intake was then hand-counted from these records;
Markers of Airway Inflammation in Induced Sputum - Sputum 8-isoprostane
Time frame: 12 Weeks
Markers of Airway Inflammation in Induced Sputum - Sputum 8-isoprostane ng/ml
1 secondary outcome
Biochemical Markers of Nutritional Status Plasma Vitamin C
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22088966Baldrick FR, Elborn JS, Woodside JV, Treacy K, Bradley JM, Patterson CC, Schock BC, Ennis M, Young IS, McKinley MC. Effect of fruit and vegetable intake on oxidative stress and inflammation in COPD: a randomised controlled trial. Eur Respir J. 2012 Jun;39(6):1377-84. doi: 10.1183/09031936.00086011. Epub 2011 Nov 16.
Related trials for Chronic Obstructive Pulmonary Disease
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
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.
Ian Young, MD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 portions fruit and vegetables/day in people with Chronic Obstructive Pulmonary Disease, run by Queen's University, Belfast 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 5 inclusion and 3 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 31 Jul 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-reported Intake of Fruit and Vegetables (Number of Portions Per Day); (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00435708, which also lists 1 linked publication.
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 31 Jul 2024.