Clinical trial for Cystic Fibrosis
Official title FEED-Cystic Fibrosis (FEED-CF)
ClinicalTrials.gov ID: NCT05766774
What this study is testing
- What it's testing
- The study wants to see if cutting added sugars in the high‑calorie, high‑fat diet typical for cystic fibrosis patients can lower the risk of developing cystic‑fibrosis‑related diabetes and reduce belly fat.
- Who it's for
- Adults with cystic fibrosis, including those with or at risk for cystic‑fibrosis‑related diabetes.
- What's involved
- Participants will receive all their meals for 8 weeks. Half will get a low‑added‑sugar, high‑fat diet, and the other half will get the usual CF diet with no sugar limits. They will be randomly assigned to one of the two diet groups.
- Time commitment
- The study lasts 8 weeks, with regular visits to receive food and have health measurements taken.
- Time commitment: about 8 weeks
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join 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
See the full eligibility criteria
- 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).
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.