Examining nutrition and body composition in cystic fibrosis patients
Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
This study is trying to see how nutrition and body strength affect adults with cystic fibrosis to help improve their care in the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jaeb Center for Health Research Academic / other |
| Locations | 23 sites (Tucson, Arizona and 22 other locations) |
| Trial ID | NCT05639556 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate various markers of body composition, strength, and nutrition in adults with cystic fibrosis (CF) by comparing them to the gold-standard dual energy X-ray absorptiometry (DXA) measurements. It will assess anthropometric measurements, hand-grip strength, and functional tests like the six-minute walk test to understand their relationship with clinical outcomes in CF. Additionally, psychosocial factors and patient-reported outcomes will be included to provide a comprehensive view of nutritional challenges in this population. The findings will establish a baseline for future nutritional interventions and research in CF.
Who should consider this trial
Good fit: Ideal candidates include adults with cystic fibrosis who have a forced expiratory volume (FEV1) of 60% or lower or 60% or greater, matched by age, gender, race, and CFTR genotype severity.
Not a fit: Patients who have undergone solid organ transplantation or have recently started new chronic therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved nutritional strategies and interventions for patients with cystic fibrosis, enhancing their overall health and lung function.
How similar studies have performed: While this approach is comprehensive, similar studies have shown success in evaluating nutritional interventions in cystic fibrosis, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cohort 1: Patients are eligible if their percentage of predicated forced expiratory volume in1 second (FEV1) is 60% or lower at screening. * Cohort 2: Patients are eligible if their percentage of predicted forced expiratory volume in 1 second (FEV1) is 60% or greater at screening. * Both cohorts match by age, gender, race and CFTR genotype severity. Exclusion Criteria: * No prior solid organ transplantation * No initiation of an investigation drug within 28 days prior to and including Visit 1 * No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston, CFTR modulator) within 28 days prior to and including Visit 1. * No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 14 days prior to and including Visit 1. * For the BIA sub-study - Individuals with an implanted pacemaker will be excluded. * No initiation of a drug for weight loss (such as a GLP-1 receptor agonist) or bariatric surgery within 6-months prior to and including the Baseline visit. * Patients with continued rapid change or extreme GI symptoms related to weight loss therapy should be excluded at the discretion of the study investigator.
Where this trial is running
Tucson, Arizona and 22 other locations
- University of Arizona — Tucson, Arizona, United States (Recruiting)
- University of Arkansas for Medical Sciences (UAMS) — Little Rock, Arkansas, United States (Recruiting)
- Yale University School of Medicine — New Haven, Connecticut, United States (Not_yet_recruiting)
- Emory — Atlanta, Georgia, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Not_yet_recruiting)
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
- Tulane University — New Orleans, Louisiana, United States (Not_yet_recruiting)
- John Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Massachusetts General Hospital (MGH) — Boston, Massachusetts, United States (Recruiting)
- Boston Children's Hospital and Brigham and Women's CF Center — Boston, Massachusetts, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Washington University School of Medicine (St. Louis) — Saint Louis, Missouri, United States (Recruiting)
- New York Medical College (NYMC) — Hawthorne, New York, United States (Recruiting)
- Northwell LIJ Adult Cystic Fibrosis Center — New Hyde Park, New York, United States (Not_yet_recruiting)
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
- University Hospitals — Cleveland, Ohio, United States (Recruiting)
- University of Oklahoma Sciences Center — Oklahoma City, Oklahoma, United States (Recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Baylor University — Houston, Texas, United States (Not_yet_recruiting)
- University of Virginia Cystic Fibrosis Center — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Adam Stein — Northwestern University
- Study coordinator: Judy Sibayan
- Email: jsibayan@jaeb.org
- Phone: (813) 975-8690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.