| NCT ID | NCT05766774 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Cystic Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-06-28 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-06-28 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Confirmed CF diagnosis 2. Ages 18 years and older 3. Baseline estimated daily total added sugar intake \>16 tsp, as estimated from the Dietary Screener Questionnaire (DSQ). Exclusion Criteria: 1. Nocturnal tube feeds 2. BMI \<18.5 kg/m2 3. Life expectancy \< 12 months 4. Confirmed diagnosis of CFRD 5. Screening OGTT showing fasting hyperglycemia (≥126 mg/dL) 6. Chronic steroid use 7. Current pregnancy or lactation 8. Inability/unwillingness to consume the majority of foods on the menu during the study period 9. MRI-incompatible metal that cannot be removed for testing 10. Uncontrolled exocrine pancreatic insufficiency/malabsorption 11. Clinically instability, defined as no changes in medical regimen (including medications and pulmonary exacerbations) for at least 21 days prior to study visit 12. Initiation of CFTR modulator within previous 8 weeks OR unstable changes in weight and lung function due to CFTR modulator use 13. Actively trying to gain or lose weight 14. Any food allergies or intolerances that cannot be accommodated 15. Any medical condition deemed by the a study physician or PI that may preclude completion of the study or interfere with primary end points.
Contact & Investigator
Jessica A Alvarez, PhD, RD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT05766774 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05766774 currently recruiting?
Yes, NCT05766774 is actively recruiting participants. Contact the research team at jessica.alvarez@emory.edu for enrollment information.
Where is the NCT05766774 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT05766774 clinical trial?
NCT05766774 is sponsored by Emory University. The principal investigator is Jessica A Alvarez, PhD, RD at Emory University. The trial plans to enroll 60 participants.