RECRUITING

FEED-Cystic Fibrosis (FEED-CF)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to determine the extent to which excess dietary sugars serve as a precipitating factor in glucose intolerance in adults with cystic fibrosis (CF), a population at especially high risk for a unique form of diabetes (CF-related diabetes, CFRD) and with standard-of-care dietary recommendations (high-calorie, high-fat) that conflict with recommendations for other forms of diabetes. This trial will investigate if the typical high-sugar, high-fat CF diet plays a role in diabetes risk and visceral fat accumulation in people with CF. A total of 30 participants will get a low-added sugar, high-fat diet and the other 30 will get a standard CF diet with no sugar restrictions. Participants will be randomized to the diet group they are assigned. All foods will be provided for 8 weeks.

Official Title

Feeding Study to Optimize Endocrine Dysfunction in Cystic Fibrosis

Quick Facts

Study Start:2023-06-28
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05766774

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Confirmed CF diagnosis
  2. 2. Ages 18 years and older
  3. 3. Baseline estimated daily total added sugar intake \>16 tsp, as estimated from the Dietary Screener Questionnaire (DSQ).
  1. 1. Nocturnal tube feeds
  2. 2. BMI \<18.5 kg/m2
  3. 3. Life expectancy \< 12 months
  4. 4. Confirmed diagnosis of CFRD
  5. 5. Screening OGTT showing fasting hyperglycemia (≥126 mg/dL)
  6. 6. Chronic steroid use
  7. 7. Current pregnancy or lactation
  8. 8. Inability/unwillingness to consume the majority of foods on the menu during the study period
  9. 9. MRI-incompatible metal that cannot be removed for testing
  10. 10. Uncontrolled exocrine pancreatic insufficiency/malabsorption
  11. 11. Clinically instability, defined as no changes in medical regimen (including medications and pulmonary exacerbations) for at least 21 days prior to study visit
  12. 12. Initiation of CFTR modulator within previous 8 weeks OR unstable changes in weight and lung function due to CFTR modulator use
  13. 13. Actively trying to gain or lose weight
  14. 14. Any food allergies or intolerances that cannot be accommodated
  15. 15. Any medical condition deemed by the a study physician or PI that may preclude completion of the study or interfere with primary end points.

Contacts and Locations

Study Contact

Jessica A Alvarez, PhD, RD
CONTACT
404-727-1390
jessica.alvarez@emory.edu
Swati Zaveri, PhD
CONTACT
440-778-8373
swati.shital.zaveri@emory.edu

Principal Investigator

Jessica A Alvarez, PhD, RD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory University Hospital
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Jessica A Alvarez, PhD, RD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-28
Study Completion Date2027-06

Study Record Updates

Study Start Date2023-06-28
Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

  • Cystic Fibrosis
  • Cystic Fibrosis-related Diabetes