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FEED-Cystic Fibrosis (FEED-CF) (FEED-CF)

Primary Purpose

Cystic Fibrosis, Cystic Fibrosis-related Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-added sugar, high-fat diet
High-added sugar, high-fat CF diet
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cystic Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Confirmed CF diagnosis based on sweat chloride concentration using pilocarpine iontophoresis and/or CFTR genotyping showing two disease causing mutations Exocrine pancreatic insufficiency Ages 18 years and older Baseline estimated daily total added sugar intake >16 tsp, as estimated from the Dietary Screener Questionnaire (DSQ) or a 3-day food record Exclusion Criteria: Nocturnal tube feeds BMI <18.5 kg/m2 Life expectancy < 12 months On waiting list for organ transplantation Confirmed diagnosis of CFRD Screening OGTT showing fasting hyperglycemia (≥126 mg/dL) Chronic oral steroid use Current pregnancy or lactation or plans to become pregnant during study period 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 (May rescreen at later date) Initiation of CFTR modulator within previous 8 weeks OR unstable changes in weight and lung function due to CFTR modulator use (May re-screen at later date) Actively trying to gain or lose weight (May re-screen at a later date) Any food allergies or intolerances that cannot be accommodated

Sites / Locations

  • Emory University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low-added sugar, high-fat diet Arm

Typical CF diet Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
Change in fasted plasma Eh[CySS] from baseline
Change in plasma Cysteine/Cystine Redox Potential (Eh[CySS]) will be measured.

Secondary Outcome Measures

Change in Gastrointestinal Symptom Rating Scale (GSRS) scale
The GSRS is a 15 items combine into five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. Possible score range is 0-7, with 7 being the worst and 0 being the best (no symptoms).
Change in hepatic and pancreatic fat volume
Dual energy X-ray absorptiometry (DEXA)-derived measurement of visceral adipose tissue (VAT) for hepatic and pancreatic fat volume. Will be assessed with a GE Lunar iDXA machine.
Change in fasted plasma Eh[GSSG]
Change in plasma glutathione disulfide (GSSG) (Eh[CySS]) will be measured.

Full Information

First Posted
February 21, 2023
Last Updated
July 5, 2023
Sponsor
Emory University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05766774
Brief Title
FEED-Cystic Fibrosis (FEED-CF)
Acronym
FEED-CF
Official Title
Feeding Study to Optimize Endocrine Dysfunction in Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Approximately half of adults with cystic fibrosis (CF), a genetic disease, will develop diabetes. Dietary strategies shown to be successful in preventing or treating other forms of diabetes in people without CF contradict current nutritional recommendations for people with CF. The nutrition standard-of-care in CF is prescription of an unrestricted high-calorie, high-fat diet because of malnutrition. However, the standard CF diet translates to low-quality diets, with excess added sugars well-above general population recommendations. Also the investigators have shown that people with CF have more fat around their abdominal organs (called visceral fat) compared to healthy controls. The hypothesis is that the typical high-sugar, high-fat CF diet plays a role in diabetes risk and visceral fat accumulation in people with CF. In this study, the investigators will test if a low-added sugar diet improves risk markers for diabetes and decreases visceral fat over 8 weeks. The study will recruit 60 participants 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. There will be a total of 4 study visits at the Emory Hospital clinical research unit. These will include: 1) a screening visit with an oral glucose tolerance test with blood draws to determine if they already have diabetes, 2) a baseline visit for an insulin secretion test (called glucose-potentiated arginine (GPA) stimulation test) to assess risk for diabetes, as well as magnetic resonance imaging (MRI) testing to measure visceral fat, 3) a 4-week visit for another oral glucose tolerance test and in-person check-in, and 4) an 8-week visit for another GPA and MRI. Blood samples will be collected and banked. In addition to all meals provided for 8 weeks, participants will be compensated for their time and effort. Participants will be recruited from patients seen at the Emory CF Clinic. Informed consent will be performed prior to any study testing. The investigators hope this study will contribute to the development of new standardized nutrition guidelines for people living with CF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Cystic Fibrosis-related Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A double-blind, randomized, parallel-group design clinical trial.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-added sugar, high-fat diet Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Typical CF diet Arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Low-added sugar, high-fat diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
High-added sugar, high-fat CF diet
Other Intervention Name(s)
Typical CF diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in acute insulin response to arginine (AIRarg) from baseline
Description
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.
Time Frame
Baseline and 8 weeks post intervention
Title
Change in acute C-peptide (ACRarg) from baseline
Description
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.
Time Frame
Baseline and 8 weeks post intervention
Title
Change in visceral adipose tissue from baseline
Description
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.
Time Frame
Baseline and 8 weeks post intervention
Title
Change in fasted plasma Eh[CySS] from baseline
Description
Change in plasma Cysteine/Cystine Redox Potential (Eh[CySS]) will be measured.
Time Frame
Baseline and 8 weeks post intervention
Secondary Outcome Measure Information:
Title
Change in Gastrointestinal Symptom Rating Scale (GSRS) scale
Description
The GSRS is a 15 items combine into five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. Possible score range is 0-7, with 7 being the worst and 0 being the best (no symptoms).
Time Frame
Baseline and 8 weeks post intervention
Title
Change in hepatic and pancreatic fat volume
Description
Dual energy X-ray absorptiometry (DEXA)-derived measurement of visceral adipose tissue (VAT) for hepatic and pancreatic fat volume. Will be assessed with a GE Lunar iDXA machine.
Time Frame
Baseline and 8 weeks post intervention
Title
Change in fasted plasma Eh[GSSG]
Description
Change in plasma glutathione disulfide (GSSG) (Eh[CySS]) will be measured.
Time Frame
Baseline and 8 weeks post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed CF diagnosis based on sweat chloride concentration using pilocarpine iontophoresis and/or CFTR genotyping showing two disease causing mutations Exocrine pancreatic insufficiency Ages 18 years and older Baseline estimated daily total added sugar intake >16 tsp, as estimated from the Dietary Screener Questionnaire (DSQ) or a 3-day food record Exclusion Criteria: Nocturnal tube feeds BMI <18.5 kg/m2 Life expectancy < 12 months On waiting list for organ transplantation Confirmed diagnosis of CFRD Screening OGTT showing fasting hyperglycemia (≥126 mg/dL) Chronic oral steroid use Current pregnancy or lactation or plans to become pregnant during study period 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 (May rescreen at later date) Initiation of CFTR modulator within previous 8 weeks OR unstable changes in weight and lung function due to CFTR modulator use (May re-screen at later date) Actively trying to gain or lose weight (May re-screen at a later date) Any food allergies or intolerances that cannot be accommodated
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica A Alvarez, PhD, RD
Phone
404-727-1390
Email
jessica.alvarez@emory.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Ivie
Phone
404-727-1399
Email
elizabeth.a.ivie@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica A Alvarez, PhD, RD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Ivie
Phone
404-727-1399
Email
elizabeth.a.ivie@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
After final publication date
IPD Sharing Access Criteria
Qualified researchers for analyses of original study endpoints not pre-specified as primary, secondary, or exploratory that contact the investigators.

Learn more about this trial

FEED-Cystic Fibrosis (FEED-CF)

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