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

January 8, 2024 updated by: Virginia Commonwealth University
The purpose of this research study is to examine if the use of antioxidant supplements impacts exercise intolerance in people with CF.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Paula Rodriguez Miguelez, PhD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2020

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20016707

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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