FEED-Cystic Fibrosis (FEED-CF)

Description

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.

Conditions

Cystic Fibrosis, Cystic Fibrosis-related Diabetes

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Study Overview

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Study Details

Study overview

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.

Feeding Study to Optimize Endocrine Dysfunction in Cystic Fibrosis

FEED-Cystic Fibrosis (FEED-CF)

Condition
Cystic Fibrosis
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory University Hospital, Atlanta, Georgia, United States, 30322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

Jessica A Alvarez, PhD, RD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2027-06