Low-added sugar, high-fat diet Arm for Cystic Fibrosis
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
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline and 8 weeks post intervention
Awards & highlights
No Placebo-Only Group
Study 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.
Eligible Conditions
- Cystic Fibrosis
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
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.
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,585 Previous Clinical Trials
2,882,368 Total Patients Enrolled
19 Trials studying Cystic Fibrosis
2,204 Patients Enrolled for Cystic Fibrosis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,262 Previous Clinical Trials
4,200,748 Total Patients Enrolled
25 Trials studying Cystic Fibrosis
14,323 Patients Enrolled for Cystic Fibrosis
Jessica A Alvarez, PhD, RDPrincipal Investigator
Emory University2 Previous Clinical Trials
140 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
140 Patients Enrolled for Cystic Fibrosis
Media Library
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."
Answered by AI