NCT05639556Active, not recruiting
Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
The goal of the study is to examine multiple markers of anthropometrics, body composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry (DXA) output, which is considered the current clinical gold-standard tool to measure body composition. The result of this study will provide detailed data regarding the nutrition and body composition within this Cystic Fibrosis population and also provide a baseline evaluation for use of these biomarkers in the future studies including evaluation of nutritional intervention. Further, the study will also include psychosocial and other patient-reported outcomes and medical contributors to understand their contributions to the nutritional failure in the adult advanced lung disease population. Finally, the study will evaluate both established and emerging nutritional and body composition parameters and link them to clinical outcomes in adults with CF across the spectrum of pulmonary function.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 14 Nov 2022
- Start date
- 20 Apr 2023
- Primary completion date
- Dec 2028
- Lead sponsor
- Jaeb Center for Health Research
- Diseases
- Cystic fibrosis
- NCT number
- NCT05639556
What you commit to
- Study type: Observational
- Planned participants: 300
- From 20 Apr 2023 to the primary completion date, Dec 2028
- 23 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No prior solid organ transplantation
- No initiation of an investigation drug within 28 days prior to and including Baseline Visit.
- No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston, CFTR modulator, etc.) within 28 days prior to and including Baseline visit.
- 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 Baseline visit.
- 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.
Other
- For the BIA sub-study - Individuals with an implanted pacemaker will be excluded.
Who the study is looking for
- Cohort 1: Participants are eligible if their percentage of predicated forced expiratory volume in 1 second (ppFEV1) is \<70% during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation)
- Cohort 2: Participants are eligible if their percentage of predicted forced expiratory volume in 1 second (ppFEV1) is 70% or greater during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
- Both cohorts match by age, gender, race and CFTR genotype severity.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| John Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Boston Children's Hospital and Brigham and Women's CF Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital (MGH) Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| University of Virginia Cystic Fibrosis Center Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| University Hospitals Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| New York Medical College (NYMC) Coordinator of this site? Confirm its status | Hawthorne | United States | Unknown status |
| Baylor University Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| University of Arkansas for Medical Sciences (UAMS) Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Rutgers Health Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Northwell LIJ Adult Cystic Fibrosis Center Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| Tulane University Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| University of Oklahoma Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Washington University School of Medicine - St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| University of Arizona Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.