Chronic Obstructive Pulmonary DiseaseEarly Phase 1NCT03819517
Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease
A Early Phase 1 study testing Resveratrol in people with Chronic Obstructive Pulmonary Disease, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Researchers have found a link between chronic obstructive pulmonary disease (COPD) and heart disease; however, a link is all they have found. Cardiovascular health in COPD is controlled by different mechanisms including vascular health and systemic inflammation. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 30 Aug 2023
- Phase
- Early 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with a clinical diagnosis of COPD known for at least one year will be allowed to participate
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages II to IV
- Breathing test ratio (FEV1/FVC) <0.7
- Amount of exhaled air (FEV1) <80% predicted after bronchodilator
- Total Lung Capacity (TLC)>80%
- Matched healthy volunteers without COPD.
Who cannot join
- FEV1/FVC>0.7
- Clinical diagnosis of heart disease, hypertension or diabetes
- Use of vasoactive medications (nitrates, Beta blockers)
- Uncontrolled high blood pressure
- Pulmonary hypertension
- Fluid in the lungs
Show all 18Show fewer
- Sleep apnea
- Thyroid problems
- Anemia
- Raynaud's phenomenon
- Gastrointestinal bleeding
- History of coagulopathies
- History of low platelets
- Gangrene of the digits
- Phenylketonuria
- Pregnant or women attempting to become pregnant
- In lactation
- Individuals who may not be able to read or understand the resveratrol label
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease: a Mechanistic Approach
Researchers have found a link between chronic obstructive pulmonary disease (COPD) and heart disease; however, a link is all they have found. Cardiovascular health in COPD is controlled by different mechanisms including vascular health and systemic inflammation. The investigators have collected preliminary data to support that concentrations of Sirtuin 1 (Sirt1), a protein that plays a key role in cardioprotection, may be involved in cardiovascular health in patients with COPD. Resveratrol, an over the counter natural polyphenol found in a variety of food, is a direct activator of Sirt1 and has been used to improve cardiovascular health in different cohorts. The current project is an attempt to expand previous findings and explore the effects of the sub-chronic use of resveratrol in sustaining the improvements in cardiovascular health in COPD.
Read the detailed description
The present study is designed as a double-blind, randomized, cross-over, placebo-controlled protocol. Patients with COPD will receive either resveratrol (500 mg) or placebo for 12 weeks. A comprehensive evaluation of cardiovascular health will be performed. Results will provide novel insights into the mechanistic role that Sirt1 mediates in COPD related vascular dysfunction and systemic inflammation.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Resveratrol, Placebo
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
Over the counter supplementation
PlaceboOther
Empty white colored soft vegetarian capsule
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Active comparator | 500 mg of time released micronized trans-Resveratrol Receives: Drug: Resveratrol |
| Placebo | Placebo comparator | Placebo will be used in the form of an empty white colored soft vegetarian capsule as resveratrol is presented Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sirt1 concentrations
Circulating concentrations of Sirt1 before and 12 weeks after both resveratrol and placebo
Measured: Baseline to 12 weeks
Change in vascular health
Assessment of vascular health through the evaluation of peripheral vascular using the flow-mediated dilation technique before and 12 weeks after both resveratrol and placebo.
Measured: Baseline to 12 weeks
Change in Systemic Inflammation
Systemic inflammation will be evaluated through the assessment of interleukin concentrations using enzyme-linked immunosorbent assay before and 12 weeks after both resveratrol and placebo.
Measured: Baseline to 12 weeks
Secondary outcomes (2)
Change in Nitric Oxide metabolism
Nitric oxide metabolism will be evaluated through Nitric oxide synthase expression using western blot analysis
Measured: Baseline to 12 weeks
Change in Inflammatory activation
The inflammatory cascade of the nuclear factor kappa B will be evaluated through assessment of p65 and p50 expression using western blot analysis
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Jul 2019
- Primary completion30 Aug 2022
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Rodriguez Miguelez, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819517
- Sponsor's protocol ID
- HM20014536
- Status last verified
- Sep 2023
- First submitted
- 12 Dec 2018
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease: a Mechanistic Approach
- ClinicalTrials.gov ID
- NCT03819517
- Acronym / sponsor ID
- HM20014536
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 28 Jan 2019 (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.
Researchers have found a link between chronic obstructive pulmonary disease (COPD) and heart disease; however, a link is all they have found. Cardiovascular health in COPD is controlled by different mechanisms including vascular health and systemic inflammation. The investigators have collected preliminary data to support that concentrations of Sirtuin 1 (Sirt1), a protein that plays a key role in cardioprotection, may be involved in cardiovascular health in patients with COPD. Resveratrol, an over the counter natural polyphenol found in a variety of food, is a direct activator of Sirt1 and has been used to improve cardiovascular health in different cohorts. The current project is an attempt to expand previous findings and explore the effects of the sub-chronic use of resveratrol in sustaining the improvements in cardiovascular health in COPD.
Detailed description
The present study is designed as a double-blind, randomized, cross-over, placebo-controlled protocol. Patients with COPD will receive either resveratrol (500 mg) or placebo for 12 weeks. A comprehensive evaluation of cardiovascular health will be performed. Results will provide novel insights into the mechanistic role that Sirt1 mediates in COPD related vascular dysfunction and systemic inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Active comparator | Drug: Resveratrol500 mg of time released micronized trans-Resveratrol |
| Placebo | Placebo comparator | Other: PlaceboPlacebo will be used in the form of an empty white colored soft vegetarian capsule as resveratrol is presented |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants with a clinical diagnosis of COPD known for at least one year will be allowed to participate
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages II to IV
- Breathing test ratio (FEV1/FVC) <0.7
- Amount of exhaled air (FEV1) <80% predicted after bronchodilator
- Total Lung Capacity (TLC)>80%
Key exclusion criteria (18 listed)
- FEV1/FVC>0.7
- Clinical diagnosis of heart disease, hypertension or diabetes
- Use of vasoactive medications (nitrates, Beta blockers)
- Uncontrolled high blood pressure
- Pulmonary hypertension
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 |
|---|---|---|
| ResveratrolOver the counter supplementation | Drug | Resveratrol |
| PlaceboEmpty white colored soft vegetarian capsule | Other | Placebo |
Primary outcome
Change in Sirt1 concentrations
Time frame: Baseline to 12 weeks
Circulating concentrations of Sirt1 before and 12 weeks after both resveratrol and placebo
Change in vascular health
Time frame: Baseline to 12 weeks
Assessment of vascular health through the evaluation of peripheral vascular using the flow-mediated dilation technique before and 12 weeks after both resveratrol and placebo.
Change in Systemic Inflammation
Time frame: Baseline to 12 weeks
Systemic inflammation will be evaluated through the assessment of interleukin concentrations using enzyme-linked immunosorbent assay before and 12 weeks after both resveratrol and placebo.
2 secondary outcomes
Change in Nitric Oxide metabolism
Time frame: Baseline to 12 weeks
Change in Inflammatory activation
Time frame: Baseline to 12 weeks
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 29 Apr 2024.
- 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.
Paula Rodriguez Miguelez, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Resveratrol in people with Chronic Obstructive Pulmonary Disease, run by Virginia Commonwealth University at 1 site in United States.
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 6 inclusion and 18 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 29 Apr 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 States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Sirt1 concentrations (time frame: Baseline to 12 weeks). The study lists 3 primary outcomes in all. 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 29 Apr 2024.