Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
Brief 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. 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.
Interventions
DRUGResveratrol
Over the counter supplementation
OTHERPlacebo
Empty white colored soft vegetarian capsule
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sirt1 concentrations | Baseline to 12 weeks | Circulating concentrations of Sirt1 before and 12 weeks after both resveratrol and placebo |
| Change in vascular health | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nitric Oxide metabolism | Baseline to 12 weeks | Nitric oxide metabolism will be evaluated through Nitric oxide synthase expression using western blot analysis |
| Change in Inflammatory activation | Baseline to 12 weeks | The inflammatory cascade of the nuclear factor kappa B will be evaluated through assessment of p65 and p50 expression using western blot analysis |
Countries
United States
Outcome results
None listed