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

NCT04166396 | Completed Early Phase 1 FDA Drug

• 1 other identifier: HM20016707
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cystic Fibrosis

Keywords

resveratrol; nicotinamide riboside; exercise intolerance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

A: Cystic fibrosis

EXPERIMENTAL

Patients with CF will be randomly assigned to resveratrol or placebo.

Drug: Resveratrol; Dietary Supplement: Placebo

A: Healthy Controls

EXPERIMENTAL

Healthy controls will be randomly assigned to resveratrol or placebo

Drug: Resveratrol; Dietary Supplement: Placebo

B: Cystic Fibrosis

EXPERIMENTAL

Patients with CF will be randomly assigned to NR or placebo.

Drug: NR; Dietary Supplement: Placebo

B: Healthy Controls

EXPERIMENTAL

Healthy controls will be randomly assigned to NR or placebo

Drug: NR; Dietary Supplement: Placebo

Interventions

Resveratrol DRUG

500 mg resveratrol, BID

A: Cystic fibrosis; A: Healthy Controls

NR DRUG

500 mg NR BID

B: Cystic Fibrosis; B: Healthy Controls

Placebo DIETARY_SUPPLEMENT

Placebo

A: Cystic fibrosis; A: Healthy Controls; B: Cystic Fibrosis; B: Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Paula Rodriguez Miguelez, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 18, 2019
• Study Start: February 17, 2020
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

US (1)