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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04166396
Enrollment
8
Registered
2019-11-18
Start date
2020-02-17
Completion date
2024-07-30
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

resveratrol, nicotinamide riboside, exercise intolerance

Brief summary

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

Detailed description

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.

Interventions

DRUGResveratrol

500 mg resveratrol, BID

DRUGNR

500 mg NR BID

DIETARY_SUPPLEMENTPlacebo

Placebo

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Sirtuin1 (Sirt1)Change from baseline to up to 20 weeksSirt1 will be assessed via a standard assay from samples taken from the participant's vein

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026