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

Primary Purpose

Cystic Fibrosis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Resveratrol

Placebo

About this trial

This is an interventional other trial for Cystic Fibrosis focused on measuring resveratrol, nicotinamide riboside, exercise intolerance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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:

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

Sites / Locations

Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

A: Cystic fibrosis

A: Healthy Controls

B: Cystic Fibrosis

B: Healthy Controls

Arm Description

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

Healthy controls will be randomly assigned to resveratrol or placebo

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

Healthy controls will be randomly assigned to NR or placebo

Outcomes

Primary Outcome Measures

Change in Sirtuin1 (Sirt1)

Sirt1 will be assessed via a standard assay from samples taken from the participant's vein

Secondary Outcome Measures

Full Information

NCT ID

NCT04166396

First Posted

November 14, 2019

Last Updated

July 19, 2023

Sponsor

Virginia Commonwealth University

1. Study Identification

Unique Protocol Identification Number

NCT04166396

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 17, 2020 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

resveratrol, nicotinamide riboside, exercise intolerance

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A: Cystic fibrosis

Arm Type

Experimental

Arm Description

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

Arm Title

A: Healthy Controls

Arm Type

Experimental

Arm Description

Healthy controls will be randomly assigned to resveratrol or placebo

Arm Title

B: Cystic Fibrosis

Arm Type

Experimental

Arm Description

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

Arm Title

B: Healthy Controls

Arm Type

Experimental

Arm Description

Healthy controls will be randomly assigned to NR or placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

Resveratrol

Intervention Description

500 mg resveratrol, BID

Intervention Type

Dietary Supplement

Intervention Name(s)

Intervention Description

500 mg NR BID

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change in Sirtuin1 (Sirt1)

Description

Sirt1 will be assessed via a standard assay from samples taken from the participant's vein

Time Frame

Change from baseline to up to 20 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paula Rodriguez Miguelez, PhD

Phone

804-828-8088

prodriguezmig@vcu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paula Rodriguez Miguelez, PhD

Organizational Affiliation

Virginia Commonwealth University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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