RecruitingNot ApplicableNCT05766774

FEED-Cystic Fibrosis (FEED-CF)

Feeding Study to Optimize Endocrine Dysfunction in Cystic Fibrosis


Sponsor

Emory University

Enrollment

60 participants

Start Date

Jun 28, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (FEED-CF) investigates whether reducing added sugar intake in adults with cystic fibrosis (CF) can improve how the body processes sugar and reduce the risk of developing cystic fibrosis-related diabetes (CFRD) — a complication that affects about 50% of adults with CF and significantly worsens their lung function and overall health. People with CF often consume high amounts of sugar to meet their elevated caloric needs, but this may contribute to impaired insulin function. Adults 18 and older with confirmed CF who consume more than 16 teaspoons of added sugar per day (assessed by a dietary screener) are eligible. Participants must have a BMI of at least 18.5 and a life expectancy of more than 12 months. Those already diagnosed with CFRD, with fasting blood sugar above 126 mg/dL, on nocturnal tube feeds, currently pregnant or breastfeeding, or who have started a CFTR modulator drug within the past 8 weeks are excluded. Cystic fibrosis-related diabetes dramatically worsens outcomes in people with CF, yet preventing it has received little research attention. A dietary intervention that could delay or prevent CFRD would be transformative — not only improving metabolic health but potentially also lung function. This trial addresses a genuinely neglected but very important question in CF care.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLow-added sugar, high-fat diet

Consist of \<5% kcal from added sugars as recommended by the American Heart Association, and the glycemic index will be 45 or lower (25% lower than typical CF diet). The macronutrient composition of both study diets will reflect the general CF recommendations for macronutrients: 35-40% of total kcal from fat and 15-20% total kcal from protein.

OTHERHigh-added sugar, high-fat CF diet

Consist of ≥13% kcal from added sugars and the glycemic index will be \>60. The macronutrient composition of both study diets will reflect the general CF recommendations for macronutrients: 35-40% of total kcal from fat and 15-20% total kcal from protein.


Locations(1)

Emory University Hospital

Atlanta, Georgia, United States

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NCT05766774


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