Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2023-08-30

Brief Summary

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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.

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Detailed Description

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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

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Resveratrol

500 mg of time released micronized trans-Resveratrol

Group Type ACTIVE_COMPARATOR

Resveratrol

Intervention Type DRUG

Over the counter supplementation

Placebo

Placebo will be used in the form of an empty white colored soft vegetarian capsule as resveratrol is presented

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Empty white colored soft vegetarian capsule

Interventions

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Resveratrol

Over the counter supplementation

Intervention Type DRUG

Placebo

Empty white colored soft vegetarian capsule

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes