FEED-Cystic Fibrosis (FEED-CF)
FEED-CF
Feeding Study to Optimize Endocrine Dysfunction in Cystic Fibrosis
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedStudy Start
First participant enrolled
June 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
April 6, 2025
April 1, 2025
4.9 years
February 21, 2023
April 3, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Change in acute insulin response to arginine (AIRarg) from baseline
Participants will undergo a Glucose-Potentiated Arginine Stimulation (GPA) Test after a 10-12 hour overnight fast to measure acute insulin (AIRarg) responses during a 230 and 340 mg/dl glucose clamp. This test will measure changes in beta cell secretory capacity.
Baseline and 8 weeks post intervention
Change in acute C-peptide (ACRarg) from baseline
Participants will undergo a Glucose-Potentiated Arginine Stimulation (GPA) Test after a 10-12 hour overnight fast to measure acute C-peptide (ACRarg) responses during a 230 and 340 mg/dl glucose clamp. This test will measure changes in beta cell secretory capacity.
Baseline and 8 weeks post intervention
Change in visceral adipose tissue from baseline
Dual energy X-ray absorptiometry (DEXA)-derived measurement of visceral adipose tissue (VAT) will be assessed with a GE Lunar iDXA machine. This will enable assessment of changes in body composition over the study.
Baseline and 8 weeks post intervention
Change in fasted plasma Eh[CySS] from baseline
Change in plasma Cysteine/Cystine Redox Potential (Eh\[CySS\]) will be measured.
Baseline and 8 weeks post intervention
Secondary Outcomes (3)
Change in Gastrointestinal Symptom Rating Scale (GSRS) scale
Baseline and 8 weeks post intervention
Change in hepatic and pancreatic fat volume
Baseline and 8 weeks post intervention
Change in fasted plasma Eh[GSSG]
Baseline and 8 weeks post intervention
Study Arms (2)
Low-added sugar, high-fat diet Arm
EXPERIMENTALPatients 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.
Typical CF diet Arm
ACTIVE COMPARATORPatients 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify 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 may not qualify 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emory University Hospital
Atlanta, Georgia, 30322, United States
Related Publications (1)
Zaveri S, Stecenko A, Hunt WR, Goss A, Sharma P, Hartman TJ, Easley K, Chandler JD, Burley TM, Driggers C, Ciccarella A, Zhou H, Narlow K, Ziegler TR, Daley T, Vellanki P, Alvarez J. Low-added sugar dietary intervention study to mitigate glucose intolerance and improve body composition in adults with cystic fibrosis: a protocol of a double-blind, randomised study. BMJ Open. 2024 Dec 26;14(12):e092503. doi: 10.1136/bmjopen-2024-092503.
PMID: 39725418DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica A Alvarez, PhD, RD
Emory University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The study team, including the investigators, statistician, and coordinator, will be blinded to diet allocation throughout. All major assessments and assays will be performed by individuals who will be blinded to the diet. Participants will not be informed of their allocated diet.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 21, 2023
First Posted
March 13, 2023
Study Start
June 28, 2023
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
April 6, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- After final publication date
- Access Criteria
- Qualified researchers for analyses of original study endpoints not pre-specified as primary, secondary, or exploratory that contact the investigators.
Actual clinical study data in raw and summary form, with protected health information removed, as well as access to the study database, will be available for reference of qualified professional colleagues and auditors up to 10 years after study publication. With appropriate subject informed consent, clinical and research data obtained from this study will be deposited into the Georgia CF Data Warehouse of the NDDK P30-supported Georgia Cystic Fibrosis Clinical and Translational Core Center.