FEED-Cystic Fibrosis (FEED-CF)
Feeding Study to Optimize Endocrine Dysfunction in Cystic Fibrosis
Emory University
60 participants
Jun 28, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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).
Exclusion Criteria15
- 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.
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Interventions
Consist of \<5% kcal from added sugars as recommended by the American Heart Association, and the glycemic index will be 45 or lower (25% lower than typical CF diet). The macronutrient composition of both study diets will reflect the general CF recommendations for macronutrients: 35-40% of total kcal from fat and 15-20% total kcal from protein.
Consist of ≥13% kcal from added sugars and the glycemic index will be \>60. The macronutrient composition of both study diets will reflect the general CF recommendations for macronutrients: 35-40% of total kcal from fat and 15-20% total kcal from protein.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05766774