Oral resveratrol supplementation in bronchiectasis
Antioxidant and anti-inflammatory effects of resveratrol in adults with bronchiectasis
Health Research Council of New Zealand
40 participants
Aug 3, 2020
Interventional
Conditions
Summary
Bronchiectasis is a debilitating, chronic respiratory condition characterised by repeated respiratory infections and intense airway inflammation, that results in impaired quality of life and deteriorating lung function. Worldwide prevalence of bronchiectasis in increasing, and prevalence in New Zealand is higher than in comparable countries, with increased rates in the Maori population and in Pacific peoples. Current treatments for bronchiectasis are primarily limited to clearance of sputum from the airway and antibiotics. In an age of increasing antibiotic resistance, there is an urgent need to develop new, non-antibiotic treatments. Resveratrol is an antioxidant found in many foods (e.g. grapes, red wine, berries, nuts). Oral supplementation has been used safely in clinical studies with beneficial anti-inflammatory effects, but it has not been studied in respiratory illnesses. We hypothesise that these anti-inflammatory and antioxidant effects will be beneficial in bronchiectasis. Potential benefits of oral resveratrol supplementation include improved quality of life, reduced infective exacerbation frequency, and reduced healthcare utilisation and associated costs. The main aim of this study is to assess if resveratrol supplementation can reduce inflammation in the lung and whether the types of bacteria and other measures of infection present in the lungs change following resveratrol supplementation. Participants in the study will take either 1 or 2 capsules, each containing 500mg resveratrol, twice daily for 12 weeks. They will attend 4 visits to Middlemore Hospital (the first visit is a screening visit). At these visits, participants will have their health-assessed (vital signs, lung function, sputum, and blood tests), complete questionnaires and study diaries.
Eligibility
Inclusion Criteria7
- Aged 18 years or over
- Able to provide written informed consent
- Able to provide spontaneous sputum sample at visit 2 (week 0)
- High-resolution CT (HRCT) chest scan confirming bronchiectasis within the last 5 years
- Clinically stable during baseline period, for 4 weeks before treatment commencement (defined as absence of clinical worsening beyond normal daily variation, with no need for increasing habitual medications or taking antibiotics or prednisone and stable spirometry)
- History of at least 1 pulmonary exacerbation requiring antibiotics in the past 12 months
- Patients with asthma and/or COPD will be included if the primary diagnosis is bronchiectasis
Exclusion Criteria16
- Oral, intravenous or inhaled antibiotics within 4 weeks prior to commencing study
- Patients taking continuous macrolide therapy (for 3 months or longer) within 3 months of screening
- Patients taking continuous oral corticosteroids (for 6 weeks or longer) or immunosuppressive agents (e.g. azathioprine, methotrexate, cyclophosphamide)
- Bronchiectasis exacerbation / respiratory infection requiring oral or intravenous antibiotic treatment within 4 weeks prior to commencing study treatment
- Use of prescribed or dietary antioxidant supplement within 1 month of screening
- Body mass index <18.5 kg/m2
- Patients with a history of non-compliance with medications
- Patients with significant medical conditions other than bronchiectasis:
- Patients with cystic fibrosis
- Patients with primary ciliary dyskinesia
- Patients with hypogammaglobulinaemia or other primary or acquired immunodeficiency
- Patients with allergic bronchopulmonary aspergillosis
- Pregnant or lactating women
- Participation in a separate clinical or device trial within 4 weeks of screening
- Allergy to any components of Transmax
- Patients with evidence of active or suspected cancer
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Interventions
This is a pilot study evaluating the anti-inflammatory and antioxidant effects of high dose oral resveratrol supplementation. Resveratrol is a naturally-occurring antioxidant, that has antimicrobial and anti-inflammatory properties. It is commercially available as a nutritional supplement, commonly at much lower doses than will be used in this study. We intend to conduct a single centre, open label, pre-post, pilot study of 40 participants. The duration of treatment in this study is 12 weeks, with a preceding 4 week screening period (during which participants will need to remain stable/free of exacerbations). All participants will take a commercially available product, "Transmax", which is taken orally as a capsule. Each capsule contains 500mg of resveratrol (with the addition of 5mg piperine and 5mg of polydatin: polydatin is a precursor of resveratrol and piperine is an extract of black pepper. Both increase oral bioavailability of resveratrol). Within the study, we will evaluate the optimal dosage of resveratrol in bronchiectasis. i) Half of participants (20 out of 40) will be randomised to receive 500mg of resveratrol (one capsule) twice a day. ii) The other half will be randomised to receive 1000mg (two capsules) twice a day. All participants and investigators will be aware of the dosages taken; participants will take either 500mg twice a day or 1000mg twice a day. This will help to determine the optimal dose of resveratrol supplementation in bronchiectasis, to guide a future, larger clinical trial that will evaluate clinical end-points. All participants will take resveratrol for 12 weeks, irrespective of the dosage provided. Patients will be required to attend Middlemore Hospital, Auckland for 4 separate visits 1) Visit 1: 'Screening' visit, to evaluate a participant's suitability for the study (week 'minus 4') 2) Visit 2: Participants attend visit 2 to begin treatment (wither 500mg twice a day, or 1000mg twice a day (week 0). 3) Visit 3: at week 4 of treatment to review participants' progress on treatment 4) Visit 4: at week 12, to complete the study. At each visit, participants will have a physical examination, provide a blood and sputum sample, complete quality of life questionnaires and perform spirometry (simple lung function test). Each visit is expected to last approximately 1 to 2 hours. Resveratrol has been shown to be safe at doses up to 5 grams (5000mg) per day. Mild gastro-intestinal side-effects have been reported at the highest doses. Participants will be advised to contact the research team if adverse effects develop, and may be advised to reduce the dose of resveratrol after consultation with the study team. Adherence will be monitored and measured by reviewing the number of capsules issued to patients as compared to the number of capsules returned at each subsequent visit. Patient's adherence with the proper use of the study drug or placebo will be assessed at visits 3 and 4, and patients will be reminded to bring all study product pack(s) (used or unused) and completed daily diary cards to these visits.
Locations(1)
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ACTRN12620000721909