Cystic FibrosisEarly Phase 1NCT04166396
Non-pulmonary Contributors of Exercise Intolerance in Patients With Cystic Fibrosis
A Early Phase 1 study testing Resveratrol and NR in people with Cystic Fibrosis, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to examine if the use of antioxidant supplements impacts exercise intolerance in people with CF. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Resveratrol and NR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2020to 30 Jul 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%
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- 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
Who cannot join
- CF
- Children 17 years old and younger
- FEV1<40% predicted
- Resting O2 saturation <90%
- Clinical diagnosis of heart disease
- Clinical diagnosis of PAH
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this research study is to examine if the use of antioxidant supplements impacts exercise intolerance in people with CF.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Resveratrol, NR, Placebo
- Keywords
- resveratrol, nicotinamide riboside, exercise intolerance
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
500 mg resveratrol, BID
NRDrug
500 mg NR BID
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| A: Cystic fibrosis | Experimental | Patients with CF will be randomly assigned to resveratrol or placebo. Receives: Drug: Resveratrol; Dietary Supplement: Placebo |
| A: Healthy Controls | Experimental | Healthy controls will be randomly assigned to resveratrol or placebo Receives: Drug: Resveratrol; Dietary Supplement: Placebo |
| B: Cystic Fibrosis | Experimental | Patients with CF will be randomly assigned to NR or placebo. Receives: Drug: NR; Dietary Supplement: Placebo |
| B: Healthy Controls | Experimental | Healthy controls will be randomly assigned to NR or placebo Receives: Drug: NR; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sirtuin1 (Sirt1)
Sirt1 will be assessed via a standard assay from samples taken from the participant's vein
Measured: Change from baseline to up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start17 Feb 2020
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Rodriguez Miguelez, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166396
- Sponsor's protocol ID
- HM20016707
- Status last verified
- Jul 2025
- First submitted
- 14 Nov 2019
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-pulmonary Contributors of Exercise Intolerance in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04166396
- Acronym / sponsor ID
- HM20016707
- Conditions
- Cystic Fibrosis
- Keywords
- resveratrol, nicotinamide riboside, exercise intolerance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A: Cystic fibrosis | Experimental | Drug: Resveratrol, Dietary Supplement: PlaceboPatients with CF will be randomly assigned to resveratrol or placebo. |
| A: Healthy Controls | Experimental | Drug: Resveratrol, Dietary Supplement: PlaceboHealthy controls will be randomly assigned to resveratrol or placebo |
| B: Cystic Fibrosis | Experimental | Drug: NR, Dietary Supplement: PlaceboPatients with CF will be randomly assigned to NR or placebo. |
| B: Healthy Controls | Experimental | Drug: NR, Dietary Supplement: PlaceboHealthy controls will be randomly assigned to NR or placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- CF
- Diagnosis of CF
- Men and women (> 18 yrs. old)
- FEV1 percent predicted > 40%
- Patients with or without CF related diabetes
Key exclusion criteria (11 listed)
- CF
- Children 17 years old and younger
- FEV1<40% predicted
- Resting O2 saturation <90%
- Clinical diagnosis of heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resveratrol500 mg resveratrol, BID | Drug | A: Cystic fibrosis, A: Healthy Controls |
| NR500 mg NR BID | Drug | B: Cystic Fibrosis, B: Healthy Controls |
| PlaceboPlacebo | Dietary supplement | A: Cystic fibrosis, A: Healthy Controls, B: Cystic Fibrosis, B: Healthy Controls |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Rodriguez Miguelez, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Resveratrol and NR in people with Cystic Fibrosis, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sirtuin1 (Sirt1) (time frame: Change from baseline to up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.