FEED-Cystic Fibrosis (FEED-CF)

Recruiting now · Not applicable

Conditions studied: Cystic Fibrosis, Cystic Fibrosis-related Diabetes

In brief

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.

Key facts

Study ID

NCT05766774

Run by

Emory University

People needed

60

Starts

2023-06-28

Expected to finish

2028-06-30

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Nocturnal tube feeds
• BMI <18.5 kg/m2
• Life expectancy < 12 months
• Confirmed diagnosis of CFRD
• Screening OGTT showing fasting hyperglycemia (≥126 mg/dL)
• Chronic steroid use
• Current pregnancy or lactation
• Inability/unwillingness to consume the majority of foods on the menu during the study period
• MRI-incompatible metal that cannot be removed for testing
• Uncontrolled exocrine pancreatic insufficiency/malabsorption
• Clinically instability, defined as no changes in medical regimen (including medications and pulmonary exacerbations) for at least 21 days prior to study visit
• Initiation of CFTR modulator within previous 8 weeks OR unstable changes in weight and lung function due to CFTR modulator use
• Actively trying to gain or lose weight
• Any food allergies or intolerances that cannot be accommodated
• Any medical condition deemed by the a study physician or PI that may preclude completion of the study or interfere with primary end points.

Where it is running

• Emory University Hospital — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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