Grants and Contracts Details
Description
PROTOCOL SUMMARY
Nutrition is a lifelong cornerstone of cystic fibrosis (CF). Starting at a very early age and
continuing into adulthood, many people with CF struggle to maintain adequate nutrition. This
can be quite stressful, both for people with CF and their family and caregivers. Ultimately,
significant interventions, such as feeding tubes, are often needed to meet nutritional needs. As
lung disease advances, nutrition becomes even more important, with nutritional derangements
(“malnutrition”) impacting both survival and eligibility for lung transplantation. Despite
emphasis on nutrition, we have very little evidence (beyond observational, cross-sectional
studies) for what it means to be “nourished” versus “malnourished.” At the other end of the
nutrition spectrum, there has been an increase in the prevalence of overweight and obesity in
the CF population, particularly with the advent of highly effective modulator therapies (HEMT).
The clinical consequences of overweight and/or obesity in CF are as yet unknown.
Currently, there are two main foci of nutrition within the CF community: (a) weight-to-height
measurements such as growth curves and body mass index (BMI), and (b) laboratory values for
micronutrients. These items are easily measured and translatable into specific goals, but there
is a paucity of evidence backing our emphasis on these foci. Other markers of nutrition status,
including body composition (muscle versus fat) and assessment of related disorders (frailty,
sarcopenia), could be even more important regarding both outcomes as well as markers for
interventions.
The overarching goal of this 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. A robust analysis will be done using both cross-sectional and longitudinal data to
characterize the performance of these biomarkers over time and establish their relationship
with DXA output. The results of this study will not only provide detailed data regarding the
nutrition and body composition within this CF population, but also provide a baseline
evaluation for use of these biomarkers for future studies including evaluation of nutritional
interventions. Further, this study will include psychosocial and other patient-reported
outcomes and medical contributors (such as hyperglycemia) to understand their contributions
to nutritional failure in the adult advanced lung disease population, which will also inform
future interventional trials. Lastly, this 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 | Active |
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Effective start/end date | 4/7/23 → 4/6/26 |
Funding
- Jaeb Center for Health Research Foundation Incorporated: $62,983.00
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