Non-pulmonary Contributors of Exercise Intolerance in Patients With Cystic Fibrosis

Early Phase 1CompletedNCT04166396

Virginia Commonwealth University8 enrolled

Overview

The purpose of this research study is to examine if the use of antioxidant supplements impacts exercise intolerance in people with CF.

Exercise intolerance is a critical problem for people with cystic fibrosis (CF) able to predict hospitalization independent of lung function. Recent studies have suggested that certain supplements may help improving exercise intolerance.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cystic Fibrosis

Interventions

ResveratrolDRUG

500 mg resveratrol, BID

NRDRUG

500 mg NR BID

PlaceboDIETARY_SUPPLEMENT

Placebo

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: CF * Diagnosis of CF * Men and women (\> 18 yrs. old) * FEV1 percent predicted \> 40% * Patients with or without CF related diabetes * Resting oxygen saturation (room air) \>90% * Traditional CF-antioxidant medications * Ability to perform reliable/reproducible PFTs * Clinically stable for 4 weeks (no exacerbations or need for antibiotic antioxidant within 4 weeks of testing or major change in medical status) * Pancreatic sufficient and pancreatic insufficient patients Exclusion Criteria: CF * Children 17 years old and younger * FEV1\<40% predicted * Resting O2 saturation \<90% * Clinical diagnosis of heart disease * Clinical diagnosis of PAH * Febrile illness within 4 weeks of a study visit * Antioxidant for pulmonary exacerbation within 4 weeks of a study visit * Currently smoking, pregnant or nursing * Vasoactive medications (i.e. nitrates, beta-blockers, Viagra etc.) * Patients with B. Cepacia

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Change in Sirtuin1 (Sirt1)

Sirt1 will be assessed via a standard assay from samples taken from the participant's vein

Time frame: Change from baseline to up to 20 weeks

Data from ClinicalTrials.gov

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