Actively Recruiting
FEED-Cystic Fibrosis (FEED-CF)
Led by Emory University · Updated on 2025-04-06
60
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
FEED-Cystic Fibrosis (FEED-CF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed cystic fibrosis diagnosis
- Age 18 years or older
- Estimated daily total added sugar intake greater than 16 teaspoons at baseline as measured by Dietary Screener Questionnaire
You will not qualify if you...
- Use of nocturnal tube feeds
- Body mass index (BMI) less than 18.5 kg/m2
- Life expectancy less than 12 months
- Confirmed diagnosis of cystic fibrosis-related diabetes (CFRD)
- Screening oral glucose tolerance test showing fasting blood sugar 126 mg/dL or higher
- Chronic steroid use
- Current pregnancy or lactation
- Unable or unwilling to eat most study foods during the trial
- Presence of MRI-incompatible metal that cannot be removed
- Uncontrolled pancreatic insufficiency or malabsorption
- Clinical instability with changes in medical treatment or pulmonary exacerbations within 21 days before study visit
- Started cystic fibrosis transmembrane conductance regulator (CFTR) modulator within 8 weeks or unstable weight/lung function changes due to CFTR modulator
- Actively trying to gain or lose weight
- Food allergies or intolerances that cannot be accommodated
- Any medical condition that may prevent study completion or affect main outcomes, as determined by study doctor
AI-Screening
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Trial Site Locations
Total: 1 location
1
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
J
Jessica A Alvarez, PhD, RD
CONTACT
S
Swati Zaveri, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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