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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 8 weeks post intervention
Awards & highlights
FEED-CF Trial Summary
This trial will study if a low-sugar, high-fat diet can reduce diabetes risk and belly fat in people with CF. Participants will get either a low-sugar or typical CF diet for 8 weeks, with all meals provided.
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.Check my eligibility
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.See study design
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.
FEED-CF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with cystic fibrosis based on sweat test or genetic testing.
Select...
My pancreas does not produce enough digestive enzymes.
FEED-CF Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Change in Gastrointestinal Symptom Rating Scale (GSRS) scale
Change in fasted plasma Eh[GSSG]
Change in hepatic and pancreatic fat volume
FEED-CF 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.
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,597 Total Patients Enrolled
20 Trials studying Cystic Fibrosis
1,886 Patients Enrolled for Cystic Fibrosis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,532 Total Patients Enrolled
26 Trials studying Cystic Fibrosis
14,337 Patients Enrolled for Cystic Fibrosis
Jessica A Alvarez, PhD, RDPrincipal InvestigatorEmory University
2 Previous Clinical Trials
140 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
140 Patients Enrolled for Cystic Fibrosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My fasting blood sugar level is 126 mg/dL or higher.I am 18 years old or older.You have metal in your body that can't be taken out for testing.I have been diagnosed with cystic fibrosis based on sweat test or genetic testing.My pancreas does not produce enough digestive enzymes.Your daily added sugar intake is more than 16 teaspoons, as calculated from a questionnaire or food record.I have been diagnosed with cystic fibrosis-related diabetes.I regularly take oral steroids.You cannot or do not want to eat most of the foods offered during the study.I started a CFTR modulator within the last 8 weeks or it has affected my weight and lung function.You are waiting to receive an organ transplant.You are not expected to live for more than 12 months.I have uncontrolled pancreatic enzyme issues.My health has been stable, with no medication changes for at least 3 weeks.You do not receive nutrition through a tube at night.You have a body mass index (BMI) lower than 18.5.
Research Study Groups:
This trial has the following groups:- Group 1: Low-added sugar, high-fat diet Arm
- Group 2: Typical CF diet Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings to join the research being conducted?
"According to the details hosted on clinicaltrials.gov, this study is not actively recruiting patients at present; it was initially posted on March 1st 2023 with its last update being made a day later. Nevertheless, there are an abundance of other trials that are currently accepting volunteers - 423 in total."
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