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

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

Detailed Description
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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.

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Dietary Supplement: Resveratrol
* Dietary Supplement: NR
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Cystic fibrosis<br>Patients with CF will be randomly assigned to resveratrol or placebo. | Dietary Supplement: Resveratrol<br>* 500 mg resveratrol, BID<br>Dietary Supplement: Placebo<br>* Placebo<br>|
| Experimental: A: Healthy Controls<br>Healthy controls will be randomly assigned to resveratrol or placebo | Dietary Supplement: Resveratrol<br>* 500 mg resveratrol, BID<br>Dietary Supplement: Placebo<br>* Placebo<br>|
| Experimental: B: Cystic Fibrosis<br>Patients with CF will be randomly assigned to NR or placebo. | Dietary Supplement: NR<br>* 500 mg NR BID<br>Dietary Supplement: Placebo<br>* Placebo<br>|
| Experimental: B: Healthy Controls<br>Healthy controls will be randomly assigned to NR or placebo | Dietary Supplement: NR<br>* 500 mg NR BID<br>Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sirtuin1 (Sirt1) | Sirt1 will be assessed via a standard assay from samples taken from the participant's vein | Change from baseline to up to 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resveratrol, nicotinamide riboside, exercise intolerance