FEED-Cystic Fibrosis (FEED-CF)

Cystic Fibrosis Clinical Trial

— FEED-CF  

Official title:

Feeding Study to Optimize Endocrine Dysfunction in Cystic Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766774
• Other study ID #: STUDY00004517
• Secondary ID: 1R01DK133523-01
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: June 2027

Study information

• Verified date: March 2024
• Source: Emory University
• Contact: Jessica A Alvarez, PhD, RD
• Phone: 404-727-1390
• Email: jessica.alvarez[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Confirmed CF diagnosis based on sweat chloride concentration using pilocarpine iontophoresis and/or CFTR genotyping showing two disease causing mutations

2. Exocrine pancreatic insufficiency

3. Ages 18 years and older

4. 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:

1. Nocturnal tube feeds

2. BMI <18.5 kg/m2

3. Life expectancy < 12 months

4. On waiting list for organ transplantation

5. Confirmed diagnosis of CFRD

6. Screening OGTT showing fasting hyperglycemia (=126 mg/dL)

7. Chronic oral steroid use

8. Current pregnancy or lactation or plans to become pregnant during study period

9. Inability/unwillingness to consume the majority of foods on the menu during the study period

10. MRI-incompatible metal that cannot be removed for testing

11. Uncontrolled exocrine pancreatic insufficiency/malabsorption

12. 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)

13. 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)

14. Actively trying to gain or lose weight (May re-screen at a later date)

15. Any food allergies or intolerances that cannot be accommodated

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis-related Diabetes
• Fibrosis

Intervention

Other:
• Low-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.
• High-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

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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).	Baseline and 8 weeks post intervention
Secondary	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.	Baseline and 8 weeks post intervention
Secondary	Change in fasted plasma Eh[GSSG]	Change in plasma glutathione disulfide (GSSG) (Eh[CySS]) will be measured.	Baseline and 8 weeks post intervention