What is the mechanism of action of this treatment?

Common treatments for Cystic Fibrosis (CF) include CFTR modulators, which correct the defective CFTR protein function, improving chloride transport and reducing mucus buildup. Dietary management, particularly high-calorie, high-fat diets, is crucial to meet the increased energy needs and maintain nutritional status. However, this can conflict with managing glucose intolerance and CF-related diabetes (CFRD). The trial investigating a low-added sugar, high-fat diet aims to balance these needs by reducing diabetes risk while ensuring adequate caloric intake. These treatments are vital for improving lung function, nutritional status, and overall quality of life in CF patients.

What side effects are associated with this type of intervention?

Common treatments for Cystic Fibrosis (CF) include enzyme supplements, antibiotics, and dietary modifications. Enzyme supplements can cause gastrointestinal issues such as bloating, constipation, or diarrhea. Antibiotics, often used to manage lung infections, can lead to side effects like nausea, diarrhea, and antibiotic resistance. Dietary modifications, particularly high-fat diets, can result in gastrointestinal discomfort and potential weight gain. The trial studying a low-added sugar, high-fat diet aims to mitigate glucose intolerance and diabetes risk, but such dietary changes may also lead to increased fat intake-related issues.

What prior FDA approvals exist?

FDA-approved treatments for Cystic Fibrosis include CFTR modulators such as elexacaftor-tezacaftor-ivacaftor, which improve weight gain and may restore pancreatic function in young children. These treatments are relevant to managing CF-related diabetes (CFRD) by enhancing overall health and potentially reducing glucose intolerance. The trial studying a low-added sugar, high-fat diet aims to mitigate diabetes risk, complementing the benefits of CFTR modulators.

What other types of research exist?

Promising alternatives for CF patients to mitigate glucose intolerance and diabetes risk include: 1) Soluble dietary fibers such as those from tartary buckwheat bran, which have shown to improve glucose and lipid metabolism. 2) Non-nutritive sweeteners like D-tagatose, which can help control glycemia. 3) L-arabinose, which has demonstrated benefits in reducing blood glucose levels and improving gut microbiota. These alternatives can be considered in dietary plans for CF patients to manage diabetes risk effectively.

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Low-Sugar High-Fat Diet for Cystic Fibrosis (FEED-CF Trial)

N/A

Recruiting

Led By Jessica A Alvarez, PhD, RD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18 years and older

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

Must not have

Screening OGTT showing fasting hyperglycemia (≥126 mg/dL)

Confirmed diagnosis of CFRD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 8 weeks post intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a low-sugar diet can reduce diabetes risk and organ fat in adults with cystic fibrosis. Participants will follow either a low-sugar, high-fat diet or their usual CF diet for a few months. The goal is to see if cutting down on sugar improves health outcomes.

Who is the study for?

Adults over 18 with confirmed cystic fibrosis, who consume more than 16 teaspoons of added sugar daily and have exocrine pancreatic insufficiency can join. Those with CFRD, recent CFTR modulator use, organ transplant waiting list status, life expectancy under a year, uncontrolled conditions or dietary restrictions that conflict with the study's menu are excluded.

What is being tested?

The FEED-CF trial is testing how diet affects diabetes risk in cystic fibrosis patients by comparing two diets: one low in added sugars but high in fats versus the standard high-sugar, high-fat CF diet. Participants will be randomly assigned to one of these diets for 8 weeks.

What are the potential side effects?

Potential side effects may include changes in blood sugar levels which could affect diabetes risk and possibly impact weight and digestion due to the dietary modifications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with cystic fibrosis based on sweat test or genetic testing.

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My pancreas does not produce enough digestive enzymes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My fasting blood sugar level is 126 mg/dL or higher.

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I have been diagnosed with cystic fibrosis-related diabetes.

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I regularly take oral steroids.

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I have uncontrolled pancreatic enzyme issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 8 weeks post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 8 weeks post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 8 weeks post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in acute C-peptide (ACRarg) from baseline

Change in acute insulin response to arginine (AIRarg) from baseline

Change in fasted plasma Eh[CySS] from baseline

+1 more

Secondary study objectives

Change in Gastrointestinal Symptom Rating Scale (GSRS) scale

Change in fasted plasma Eh[GSSG]

Change in hepatic and pancreatic fat volume

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Low-added sugar, high-fat diet ArmExperimental Treatment1 Intervention

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.

Group II: Typical CF diet ArmActive Control1 Intervention

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.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cystic Fibrosis (CF) include CFTR modulators, which correct the defective CFTR protein function, improving chloride transport and reducing mucus buildup. Dietary management, particularly high-calorie, high-fat diets, is crucial to meet the increased energy needs and maintain nutritional status. However, this can conflict with managing glucose intolerance and CF-related diabetes (CFRD). The trial investigating a low-added sugar, high-fat diet aims to balance these needs by reducing diabetes risk while ensuring adequate caloric intake. These treatments are vital for improving lung function, nutritional status, and overall quality of life in CF patients.

Cystic fibrosis transmembrane conductance regulator (CFTR) and autophagy: hereditary defects in cystic fibrosis versus gluten-mediated inhibition in celiac disease.Emerging drugs for cystic fibrosis.Treatment options for cystic fibrosis: state of the art and future perspectives.