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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
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

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emory
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
John Hopkins University
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Boston Children's Hospital and Brigham and Women's CF Center
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Massachusetts General Hospital (MGH)
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Medical University of South Carolina
Coordinator of this site? Confirm its status
CharlestonUnited StatesUnknown status
University of Virginia Cystic Fibrosis Center
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesUnknown status
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
University of Cincinnati
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
University Hospitals
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ClevelandUnited StatesUnknown status
New York Medical College (NYMC)
Coordinator of this site? Confirm its status
HawthorneUnited StatesUnknown status
Baylor University
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
University of Iowa
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Iowa CityUnited StatesUnknown status
University of Kentucky
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LexingtonUnited StatesUnknown status
University of Arkansas for Medical Sciences (UAMS)
Coordinator of this site? Confirm its status
Little RockUnited StatesUnknown status
University of Minnesota
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status
Rutgers Health
Coordinator of this site? Confirm its status
New BrunswickUnited StatesUnknown status
Northwell LIJ Adult Cystic Fibrosis Center
Coordinator of this site? Confirm its status
New Hyde ParkUnited StatesUnknown status
Tulane University
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New OrleansUnited StatesUnknown status
University of Oklahoma Sciences Center
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Oklahoma CityUnited StatesUnknown status
University of Pittsburgh Medical Center
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PittsburghUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Washington University School of Medicine - St. Louis
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
University of Arizona
Coordinator of this site? Confirm its status
TucsonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.