FEED-Cystic Fibrosis (FEED-CF)
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.
Conditions:
🦠 Cystic Fibrosis 🦠 Cystic Fibrosis-related Diabetes
🗓️ Study Start (Actual) 28 June 2023
🗓️ Primary Completion (Estimated) June 2027
✅ Study Completion (Estimated) June 2027
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Confirmed CF diagnosis
    • 2. Ages 18 years and older
    • 3. Baseline estimated daily total added sugar intake \>16 tsp, as estimated from the Dietary Screener Questionnaire (DSQ).

    Exclusion Criteria:

    • 1. Nocturnal tube feeds
    • 2. BMI \<18.5 kg/m2
    • 3. Life expectancy \< 12 months
    • 4. Confirmed diagnosis of CFRD
    • 5. Screening OGTT showing fasting hyperglycemia (≥126 mg/dL)
    • 6. Chronic steroid use
    • 7. Current pregnancy or lactation
    • 8. Inability/unwillingness to consume the majority of foods on the menu during the study period
    • 9. MRI-incompatible metal that cannot be removed for testing
    • 10. Uncontrolled exocrine pancreatic insufficiency/malabsorption
    • 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. Initiation of CFTR modulator within previous 8 weeks OR unstable changes in weight and lung function due to CFTR modulator use
    • 13. Actively trying to gain or lose weight
    • 14. Any food allergies or intolerances that cannot be accommodated
    • 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 21 February 2023
  • First Submitted that Met QC Criteria 2 March 2023
  • First Posted 13 March 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 June 2024
  • Last Update Posted 13 June 2024
  • Last Verified June 2024