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

Early Phase 1

Recruiting

• Conditions: Cystic Fibrosis
• Interventions: Drug: Resveratrol; Drug: NR; Dietary Supplement: Placebo

• Registration Number: NCT04166396
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-18
• Study Start: 2020-02-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A: Cystic fibrosis	Resveratrol	Patients with CF will be randomly assigned to resveratrol or placebo.
A: Cystic fibrosis	Placebo	Patients with CF will be randomly assigned to resveratrol or placebo.
A: Healthy Controls	Placebo	Healthy controls will be randomly assigned to resveratrol or placebo
B: Cystic Fibrosis	NR	Patients with CF will be randomly assigned to NR or placebo.
B: Cystic Fibrosis	Placebo	Patients with CF will be randomly assigned to NR or placebo.
B: Healthy Controls	NR	Healthy controls will be randomly assigned to NR or placebo
B: Healthy Controls	Placebo	Healthy controls will be randomly assigned to NR or placebo
A: Healthy Controls	Resveratrol	Healthy controls will be randomly assigned to resveratrol or placebo

Primary Outcome Measures

Name	Time	Method
Change in Sirtuin1 (Sirt1)	Change from baseline to up to 20 weeks	Sirt1 will be assessed via a standard assay from samples taken from the participant's vein

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States