Antioxidant Supplements for Cystic Fibrosis

Overseen By Paula Rodriguez Miguelez, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Virginia Commonwealth University

Must be taking: CF-antioxidants

Must not be taking: Vasoactive medications

Disqualifiers: Heart disease, PAH, B. Cepacia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if antioxidant supplements can help people with cystic fibrosis (CF) exercise better. People with CF often struggle with exercise, which can lead to more hospital visits. Antioxidants might help by protecting their cells from damage, making it easier for them to stay active. Glutathione, an antioxidant, has shown potential in improving lung function and reducing oxidative stress in cystic fibrosis patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain medications like nitrates, beta-blockers, or Viagra.

What evidence supports the effectiveness of resveratrol as a treatment for cystic fibrosis?

Resveratrol, a component of the treatment, has shown antioxidant properties in studies, which may help protect cells from damage. However, its effectiveness specifically for cystic fibrosis is not directly supported by the available research. ^{1 2 3 4 5}

Is resveratrol safe for human use?

A study on resveratrol supplementation in older adults found it to be safe, with no significant adverse effects reported and blood chemistry values remaining normal over a 12-week period. ^{3 6 7 8 9}

How is the drug resveratrol unique in treating cystic fibrosis?

Resveratrol is unique in treating cystic fibrosis because it is a natural antioxidant found in red wine and grapes, known for its anti-inflammatory and antioxidative properties, which may help reduce oxidative stress in patients. Unlike other treatments, resveratrol's effectiveness can be enhanced when combined with other antioxidants like vitamin C. ^{3 5 6 10 11}

Research Team

Paula Rodriguez Miguelez, PhD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for adults over 18 with Cystic Fibrosis who can perform lung function tests and have an FEV1 percent predicted above 40%. They must not be current smokers, pregnant, or nursing, and should be clinically stable without recent exacerbations or heart disease.

Inclusion Criteria

I have been medically stable for the last 4 weeks.

You may or may not have diabetes related to cystic fibrosis.

I have been diagnosed with cystic fibrosis.

Exclusion Criteria

I have not had a fever or flu-like illness in the last 4 weeks.

I have been diagnosed with heart disease.

Patients with B. Cepacia infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive antioxidant supplements or placebo to assess impact on exercise intolerance

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NR
• Placebo
• Resveratrol

Trial Overview The study is testing the effects of antioxidant supplements Resveratrol and NR on exercise intolerance in CF patients compared to a placebo. Participants will receive one of these treatments to see if it improves their ability to exercise.

Participant Groups

Group I: B: Healthy Controls Experimental Treatment 2 Interventions

Healthy controls will be randomly assigned to NR or placebo

Group II: B: Cystic Fibrosis Experimental Treatment 2 Interventions

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

Group III: A: Healthy Controls Experimental Treatment 2 Interventions

Healthy controls will be randomly assigned to resveratrol or placebo

Group IV: A: Cystic fibrosis Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Findings from Research

Red wines contain significantly higher levels of beneficial compounds like resveratrol and piceid, averaging 4.37 mg/liter, compared to only 0.68 mg/liter in white wines, suggesting a stronger protective effect against cardiovascular disease from red wine consumption.

The study analyzed 42 wines from various regions in Japan, confirming that specific grape varieties, such as Pinot noir, Merlot, and Zweigeltrebe, have particularly high resveratrol content, which may contribute to their health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contents of resveratrol, piceid, and their isomers in commercially available wines made from grapes cultivated in Japan. Sato, M., Suzuki, Y., Okuda, T., et al.[2019]

Trans-resveratrol (t-RESV), found in grape skins and red wine, shows significant anti-inflammatory and anticarcinogenic properties in various experimental models, highlighting its potential as a therapeutic agent.

The cis isomer of resveratrol (c-RESV) is less studied and not commercially available, leading to a gap in understanding its pharmacological effects compared to the well-researched t-RESV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative studies of the antioxidant effects of cis- and trans-resveratrol. Orallo, F.[2022]

A double-blind, randomized, placebo-controlled trial involving 32 overweight older adults showed that resveratrol supplementation at doses of 300mg and 1000mg per day is safe and well-tolerated, with no significant adverse effects reported.

Participants taking resveratrol experienced significantly lower glucose levels compared to those on placebo, suggesting potential benefits for metabolic health, although their glucose levels did not differ from their baseline measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and metabolic outcomes of resveratrol supplementation in older adults: results of a twelve-week, placebo-controlled pilot study. Anton, SD., Embry, C., Marsiske, M., et al.[2022]

Trans-resveratrol is primarily metabolized into two main forms: trans-resveratrol-3-O-glucuronide and trans-resveratrol-3-sulfate, which were found abundantly in rat urine and mouse serum, indicating effective metabolism in the body.

The study found virtually no unconjugated resveratrol in urine or serum samples, suggesting that previous in vitro studies using only unconjugated resveratrol may not accurately reflect its metabolism and effects in living organisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human, rat, and mouse metabolism of resveratrol. Yu, C., Shin, YG., Chow, A., et al.[2019]

This study analyzed the content of trans- and cis-resveratrol in 18 commercial Serbian wines, revealing that trans-resveratrol was present in all but one sample, with concentrations ranging from 0.11 to 1.69 mg/L.

Cis-resveratrol was found in 12 out of the 18 wines, with levels between 0.12 and 1.49 mg/L, indicating that Serbian wines contain significant amounts of these beneficial compounds, which are associated with various health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of trans- and cis-resveratrol in Serbian commercial wines. Cvejic, JM., Djekic, SV., Petrovic, AV., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase I dose escalation pharmacokinetic study in healthy volunteers of resveratrol, a potential cancer chemopreventive agent. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of resveratrol on lipid profile: An updated systematic review and meta-analysis on randomized clinical trials. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Contents of resveratrol, piceid, and their isomers in commercially available wines made from grapes cultivated in Japan. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Resveratrol from red grapes - pedestrian polyphenol or useful anticancer agent? [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Inhibition of free radical-induced peroxidation of rat liver microsomes by resveratrol and its analogues. [2019]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Comparative studies of the antioxidant effects of cis- and trans-resveratrol. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Safety and metabolic outcomes of resveratrol supplementation in older adults: results of a twelve-week, placebo-controlled pilot study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Human, rat, and mouse metabolism of resveratrol. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Determination of trans- and cis-resveratrol in Serbian commercial wines. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Liposomes as carriers of the lipid soluble antioxidant resveratrol: evaluation of amelioration of oxidative stress by additional antioxidant vitamin. [2018]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Synthesis and evaluation of cytotoxicity of stilbene analogues. [2022]