Actively Recruiting
Led by Emory University · Updated on 2026-06-03
60
Participants Needed
1
Research Sites
N/A
Total Duration
E
Emory University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
Researchers are investigating how excess dietary sugars affect glucose intolerance and diabetes risk in adults with cystic fibrosis (CF), a genetic disease. CF patients often follow a high-calorie, high-fat diet to prevent malnutrition, but this diet includes more added sugars than recommended. The study aims to understand if this high-sugar diet contributes to diabetes risk and increased abdominal fat in people with CF. The trial will involve 60 adults with CF who will be randomly assigned to one of two diet groups for 8 weeks. One group will receive a low-added sugar, high-fat diet with less than 5% of calories from added sugars and a glycemic index of 45 or lower. The other group will follow a typical CF diet with high added sugar (13% or more of calories) and a higher glycemic index above 60. All meals, snacks, and drinks will be delivered to participants' homes every 3 to 4 days, and diets will be tailored to maintain body weight. Participants will have four study visits at the clinical research unit: a screening visit with tests to check for diabetes, a baseline visit with insulin tests and MRI scans to measure visceral fat, a 4-week check-in with another glucose tolerance test, and a final 8-week visit repeating the insulin and MRI tests. Blood samples will be collected and stored. Researchers will measure changes in insulin response, visceral fat, and other markers related to diabetes risk. Participants will be compensated for their time and effort during the study.
CONDITIONS
FEED-Cystic Fibrosis (FEED-CF)
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including an oral glucose tolerance test with blood draws to determine diabetes status
Duration - 1 day
Participants undergo tests to assess diabetes risk and measure visceral fat before starting the diet intervention.
1 baseline visit (in-person) including an insulin secretion test (glucose-potentiated arginine stimulation test) and MRI testing
Duration - 8 weeks
Participants receive either a low-added sugar, high-fat diet or a typical CF diet with no sugar restrictions for 8 weeks. All foods are provided and delivered to participants' homes every 3-4 days. Participants are expected to consume only the provided foods.
No in-person visits during diet delivery; food delivered to homes every 3-4 days
Duration - 1 day
Participants return for an oral glucose tolerance test and an in-person check-in to monitor progress during the diet intervention.
1 visit (in-person) at 4 weeks including an oral glucose tolerance test and health check-in
Duration - 1 day
Participants complete final tests to assess changes in diabetes risk and visceral fat after the 8-week diet intervention.
1 visit (in-person) including an insulin secretion test (glucose-potentiated arginine stimulation test) and MRI testing
Total: 1 location
1
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
J
Jessica A Alvarez, PhD, RD
S
Swati Zaveri, PhD
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Swati Zaveri, Arlene Stecenko, William R Hunt...
https://pubmed.ncbi.nlm.nih.gov/39725418