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Not recruiting

Nutrition

Sponsor:

Jaeb Center for Health Research

Code:

NCT05639556

Conditions

Cystic Fibrosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMI and lean mass index from DXA

Anthropometric Measurements

Hand-grip strength

Six-minute walk Test

Sit-to-Stand Test

Study Details

Brief summary:

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.

Conditions

Cystic Fibrosis

Study ID

NCT05639556

Start date

Apr 20, 2023

Status verified date

Aug, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Forced expiratory volume in 1 second (FEV1) <70% predicted during the 12 months prior to enrollment (>50% of measurements, eliminating periods of exacerbation). If no stable spirometry data are available in the 12 months prior to enrollment, from the prior 24 months will be used.

Cohort 2

FEV1 ≥70% predicted during the 12 months prior to enrollment (>50% of measurements, eliminating periods of exacerbation).

Interventions

BMI and lean mass index from DXA

Estimate and compare correlation between lean mass index from DXA and BMI

Anthropometric Measurements

Skinfold will be assessed with calipers. Circumference will be measured with a tape measure.

Hand-grip strength

A small, handheld dynamometer will be used to measure grip strength, a measure of function, on each hand.

Six-minute walk Test

This will be another functional assessment of fitness. Participants will be asked to walk at their normal pace for 6 minutes.The total distance walked in that time will be measured.

Sit-to-Stand Test

This will be used as a functional assessment of fitness and lower extremity strength. Participants will start seated on a chair and be asked to complete as many sit-to-stand repetitions without using their arms for one minute.

Short physical performance battery (SPPB)

This is an assessment of frailty. The test is completed in approximately 8 minutes. The test consists of 3 assessments: 1) Balance tests where the participant stands and tries to balance with their feet in various positions for 10 seconds each without assistance (side-by-side, heel-to-side, and heel-to-toe); 2) Two 4-meter gait speed tests; and 3) Chair-stand tests (single chair stand, 5 chair stands).

BIA Sub-study

A minimum of 50 individuals will be enrolled. Body composition will be assessed at each study visit using study bioelectrical impendence analysis (BIA).

Accelerometry to assess physical activity

Participants will be provided with a wrist-worn accelerometer/heart rate monitor at the baseline study visit and asked to wear it continuously for at least 3-10 days (two weekdays, one weekend day). Approximately every 3 months, the participant will be asked to again wear the accelerometer. Participants will be able to keep their accelerometers.

Gastrointestinal (GI) and nutrition questionnaires:

Subjects will complete surveys regarding gastrointestinal (GI) symptoms, including the Patient Assessment of Constipation (PAC-SYM) Score, Patient Assessment of Gastrointestinal Symptoms (PACGI-SYM) Score, the Bristol Stool Chart, and the scored Patient-Generated Subjective Global Assessment (PG-SGA).

Psychosocial questionnaire: PHQ-8

This is an 8-item scale that measures depressive symptoms over the past two weeks.

Psychosocial questionnaire: GAD-7

This is a 7-items scale that measures anxiety symptoms over the past two weeks, from not at all to nearly every day.

Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ)

This is a 15-item scale that assesses the degree to which participants' motivation is autonomous or self-regulated.

Psychosocial questionnaire: CF Fatalism Scale

The CF Fatalism Scale measures the belief in a lack of personal power or control over one's future and has 13 items.

Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA)

The Body Esteem Scale for Adolescents and Adults (BESAA) is 23-item measurement of self-evaluations of one's body or appearance.

12-month Questionnaire

A short questionnaire designed to explore participants' perspectives of the acceptability and feasibility of nutritional assessments used in STRONG-CF will be given to all study participants at the end of the study.

Oral glucose tolerance testing (OGTT)

For subjects without previously diagnosed CFRD, an OGTT will be performed at baseline and 12-months with samples analyzed at the central lab.

Continuous glucose monitoring (CGM)

Subjects will wear a Dexcom G6Pro sensor in blinded mode for three 10-day periods to collect comprehensive glucose data.

Chest CT scans (When available within the past 6 months in medical records)

Standard of Care chest CT images will be drawn from the medical record, as available, from enrolled participants. FEV1 measurements prior to chest CT scans will be recorded to account for possible illness occurring at the time of scanning. Quantitative assessment of the pectoralis muscle area will be performed on the first single axial image above the aortic arch. Any additional standard of care chest CT's that are performed while the participant is enrolled in the study will also be collected and have a quantitative assessment of the pectoralis muscle performed.

Hologic Dual X-Ray Absorptiometry (DXA)

DXA measurements for whole body, total hip and lumbar spine will be acquired using the Hologic DXA and standard positioning as noted in the DXA Manual of Operations. DXA will be used to estimate total and regional body composition, which will include body fat and lean body mass. This will be used as the gold standard from which to validate BIA and MAMC.

Ultrasound Sub-study of assessment of appendage muscles using ultrasound

A minimum of 50 individuals will be enrolled. At each study visit, participants will undergo ultrasound muscle measurements (cross-sectional area and muscle thickness) of the biceps and quadriceps on each (left and right) side of the body (4 total areas). These measurements will be obtained in triplicate for each patient.

Psychosocial questionnaire: Hunger Vital Sign questionnaire

Screening tool for identifying households at risk of food insecurity and poor health outcomes linked to food insecurity with 3-items over the last 12 months.

Respiratory symptom questionnaire: CRISS

Chronic Respiratory Infection Symptom Score (CRISS) is an 8-item respiratory symptom questionnaire covering the last 24-hours.

Spirometry

Spirometry will be performed in accordance with the current American Thoracic Society recommendations for the performance and interpretation of tests.

Psychosocial questionnaire: Additional Health Questionnaire

Single question over the last 3 months/90 days about cannabis use for GI problems and appetite. The clinical sites will not see the responses to this question. It will be completed by the participant online either during the study visit or at home.

CF Management Questionnaire

Assessment of prior 12-month management of cystic fibrosis, including treatments, medication intake and hospitalizations. This questionnaire will only be completed at 24- and 36- month visits.

Food Frequency Questionnaire

Assessment of prior 12-month nutritional intake being completed at Baseline (no later than 6-month visit) and 12-month visit.

Primary outcome measure

  • Correlation between DXA lean mass index and BMI [ Time Frame: Baseline and 1 year ]
  • Correlation between DXA lean mass index and mid-arm muscle circumference [ Time Frame: Baseline and 1 year ]
  • Correlation between DXA lean mass index and hand-grip strength [ Time Frame: Baseline and 1 year ]
  • Correlation between DXA lean mass index and the 6-minute walk distance traveled [ Time Frame: Baseline and 1 year ]
  • Correlation between DXA lean mass index and the 1-minute sit-to-stand number of repetitions [ Time Frame: Baseline and 1 year ]
  • Correlation between DXA lean mass index and Short Physical Performance Battery frailty score [ Time Frame: Baseline and 1 year ]

Central Contacts and Locations

Central contacts

Judy Sibayan

(813) 975-8690jsibayan@jaeb.org

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Cori Daines

cdaines@arizona.edu

Elizabeth Ryan

520-626-3125elizabethryan@email.arizona.edu

University of Arkansas for Medical Sciences (UAMS)

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Rajani Jagana

5016865525RJagana@uams.edu

Kathleen Hicks

hicksKathleenT@uams.edu

Emory

Recruiting

Atlanta, Georgia, United States, 30324

Contacts

William Hunt

4047787929randy.hunt@emory.edu

Joy Dangerfield

4047787929jdanger@emory.edu

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Adam Stein

3126954077adam.stein@northwestern.edu

Rachel Nelson

rachel.nelson@northwestern.edu

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40508

Contacts

Mark Wurth

859-257-5087mark.wurth@uky.edu

Christina Payne

859-257-5087christina.payne@uky.edu

John Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Noah Lechtzin

4109551167nlechtz@jhmi.edu

Azar Nouraky

azar.nouraky@jhmi.edu

Massachusetts General Hospital (MGH)

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Melissa Putman

msputman@partners.org

Amy Sabean

asabean@mgh.harvard.edu

Boston Children's Hospital and Brigham and Women's CF Center

Recruiting

Boston, Massachusetts, United States, 02120

Contacts

Gregory Sawicki

6173551834Gregory.Sawicki@childrens.harvard.edu

Tucker Reynard

Tucker.Reynard@childrens.harvard.edu

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Joanne Billings

612-625-7995billi001@umn.edu

Alyssa Perry

612-625-7995ahperry@umn.edu

Washington University School of Medicine (St. Louis)

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Jeffrey Atkinson

3147472940atkinsonj@wustl.edu

Irma Bauer

irmabauer@wustl.edu

Rutgers Health

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Sarah McCracken

7326670746sem322@rwjms.rutgers.edu

New York Medical College (NYMC)

Recruiting

Hawthorne, New York, United States, 10532

Contacts

Allen Dozor

9144040152Allen_dozor@nymc.edu

Armando Ramirez

Aramirez7@nymc.edu

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Veronica Indihar

513-558-7036indihama@ucmail.uc.edu

Nicole Hummel

513-558-7036hummelne@ucmail.uc.edu

University Hospitals

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Kimberly McBennett

216-286-0709kimberly.McBennett@uhhospitals.org

Emily Witte

216-286-0709Emily.Witte@Uhhospitals.org

University of Oklahoma Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Nighat F Mehdi

405-271-6216nighat-mehdi@ouhsc.edu

Tiffany McCrabb

tiffany-mccrabb@ouhsc.edu

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Aaron Trimble

503-418-8108trimblea@ohsu.edu

Brendan Klein

503-418-8108kleinb@ohsu.edu

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Joseph Pilewski

412-692-5873pilewskijm@upmc.edu

Paul Rebovich

412-692-5873paul.rebovich@chp.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Christina Mingora

8437923710mingora@musc.edu

Audra Wiser

wisera@musc.edu

University of Virginia Cystic Fibrosis Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Linsay Somerville

434-297-7773LL7Y@hscmail.mcc.virginia.edu

Anne Stewart

acs8qr@uvahealth.org

More Information

Sponsor

Jaeb Center for Health Research

Last update posted

Aug 11, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Jaeb Center for Health Research on 2025-08-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.