NCT05766774Recruiting
FEED-Cystic Fibrosis (FEED-CF)
Feeding Study to Optimize Endocrine Dysfunction in Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 21 Feb 2023
- Start date
- 28 Jun 2023
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Emory University
- Diseases
- Cystic fibrosis
- NCT number
- NCT05766774
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 28 Jun 2023 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic steroid use
- 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
Other illness
- Uncontrolled exocrine pancreatic insufficiency/malabsorption
- 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.
Lab values
- Screening OGTT showing fasting hyperglycemia (≥126 mg/dL)
Other
- Nocturnal tube feeds
- BMI \<18.5 kg/m2
- Life expectancy \< 12 months
- Confirmed diagnosis of CFRD
- 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
- Actively trying to gain or lose weight
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.