FEED-Cystic Fibrosis (FEED-CF) (FEED-CF)
Cystic Fibrosis, Cystic Fibrosis-related Diabetes
About this trial
This is an interventional prevention trial for Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria: Confirmed CF diagnosis based on sweat chloride concentration using pilocarpine iontophoresis and/or CFTR genotyping showing two disease causing mutations Exocrine pancreatic insufficiency Ages 18 years and older Baseline estimated daily total added sugar intake >16 tsp, as estimated from the Dietary Screener Questionnaire (DSQ) or a 3-day food record Exclusion Criteria: Nocturnal tube feeds BMI <18.5 kg/m2 Life expectancy < 12 months On waiting list for organ transplantation Confirmed diagnosis of CFRD Screening OGTT showing fasting hyperglycemia (≥126 mg/dL) Chronic oral steroid use Current pregnancy or lactation or plans to become pregnant during study period 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 (May rescreen at later date) Initiation of CFTR modulator within previous 8 weeks OR unstable changes in weight and lung function due to CFTR modulator use (May re-screen at later date) Actively trying to gain or lose weight (May re-screen at a later date) Any food allergies or intolerances that cannot be accommodated
Sites / Locations
- Emory University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Low-added sugar, high-fat diet Arm
Typical CF diet Arm
Patients will receive a low-added sugar, high-fat diet for 8 weeks. Study menus will be designed by registered dietitians using the Nutrient Database System for Research (NDSR) software program with a 2-wk rotation.Total kcal provided will be individually tailored to maintain body weight and adjusted throughout as needed. All foods (including snacks and drinks) for 8 wks will be delivered to participants' homes. Menus will be designed so that food will be delivered to subjects' homes every 3-4 days. It will be expected that participants consume only the foods provided by the study.
Patients will receive a high-added sugar, high-fat CF diet for 8 weeks. Study menus will be designed by registered dietitians using the Nutrient Database System for Research (NDSR) software program with a 2-wk rotation. Total kcal provided will be individually tailored to maintain body weight and adjusted throughout as needed. All foods (including snacks and drinks) for 8 wks will be delivered to participants' homes. Menus will be designed so that food will be delivered to subjects' homes every 3-4 days. It will be expected that participants consume only the foods provided by the study.