Feeding Study to Optimize Endocrine Dysfunction in Cystic Fibrosis

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Georgia
Emory University Hospital
RECRUITING
Atlanta
Contact Information
Primary
Jessica A Alvarez, PhD, RD
jessica.alvarez@emory.edu
404-727-1390
Backup
Swati Zaveri, PhD
swati.shital.zaveri@emory.edu
440-778-8373
Time Frame
Start Date: 2023-06-28
Estimated Completion Date: 2028-06
Participants
Target number of participants: 60
Treatments
Experimental: Low-added sugar, high-fat diet Arm
Patients will receive a low-added sugar, high-fat diet for 8 weeks. Study menus will be designed by registered dietitians using the Nutrient Database System for Research (NDSR) software program with a 2-wk rotation.Total kcal provided will be individually tailored to maintain body weight and adjusted throughout as needed. All foods (including snacks and drinks) for 8 wks will be delivered to participants' homes. Menus will be designed so that food will be delivered to subjects' homes every 3-4 days. It will be expected that participants consume only the foods provided by the study.
Active_comparator: Typical CF diet Arm
Patients will receive a high-added sugar, high-fat CF diet for 8 weeks. Study menus will be designed by registered dietitians using the Nutrient Database System for Research (NDSR) software program with a 2-wk rotation. Total kcal provided will be individually tailored to maintain body weight and adjusted throughout as needed. All foods (including snacks and drinks) for 8 wks will be delivered to participants' homes. Menus will be designed so that food will be delivered to subjects' homes every 3-4 days. It will be expected that participants consume only the foods provided by the study.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Emory University

This content was sourced from clinicaltrials.gov