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New treatment option for Cystic Fibrosis
Official title FEED-Cystic Fibrosis (FEED-CF)
ClinicalTrials.gov ID: NCT05766774
What this study is testing
- What it's testing
- 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.
- 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's taking place
- Atlanta, Georgia, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 - 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 - 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?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.