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Behavioural Intervention
High vs Low Glycemic Index Meals for Cystic Fibrosis
N/A
Recruiting
Led By Tanicia Daley, MD, MPH
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see how consuming excess simple sugars affects the development of diabetes in people with Cystic fibrosis. They will give participants different meals and drinks to see how it affects their blood sugar
Who is the study for?
This study is for adolescents and young adults with Cystic Fibrosis. It's designed to see if different types of sugar in meals affect their blood sugar levels and insulin function. Participants will be given meals with high or low glycemic index sugars, some including sugary drinks.
What is being tested?
The trial tests how the body reacts to meals that have sugars which are absorbed at different rates (high vs low glycemic index) and whether adding a sugary drink makes a difference. Blood samples before and after eating measure changes in glucose, insulin function, and hormones related to digestion.
What are the potential side effects?
Since this trial involves dietary intake rather than medication, side effects may include discomfort from blood draws or potential short-term changes in blood sugar levels due to the meal challenges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability
Investigator Fidelity
Participant Fidelity
+4 moreSecondary study objectives
Change in incremental glucose AUC
Change in plasma Cysteine (Cys)
Change in plasma Cystine (CySS)
+12 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: SSB+ HI- GIExperimental Treatment2 Interventions
All standardized mixed meal challenges will be similar in calories (kcal) and percent of calories from carbohydrates (45%), protein (15%), and fat (40%). Each meal will provide 1/3rd of the subject's estimated kcal needs per current CF nutrition guidelines
Group II: SSB + LO- GIExperimental Treatment2 Interventions
All standardized mixed meal challenges will be similar in calories (kcal) and percent of calories from carbohydrates (45%), protein (15%), and fat (40%). Each meal will provide 1/3rd of the subject's estimated kcal needs per current CF nutrition guidelines
Group III: NSSB+ LO- GIExperimental Treatment1 Intervention
All standardized mixed meal challenges will be similar in calories (kcal) and percent of calories from carbohydrates (45%), protein (15%), and fat (40%). Each meal will provide 1/3rd of the subject's estimated kcal needs per current CF nutrition guidelines
Group IV: NSSB+ HI- GIExperimental Treatment1 Intervention
All standardized mixed meal challenges will be similar in calories (kcal) and percent of calories from carbohydrates (45%), protein (15%), and fat (40%). Each meal will provide 1/3rd of the subject's estimated kcal needs per current CF nutrition guidelines
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,695 Previous Clinical Trials
2,603,698 Total Patients Enrolled
20 Trials studying Cystic Fibrosis
1,906 Patients Enrolled for Cystic Fibrosis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,435 Previous Clinical Trials
4,323,857 Total Patients Enrolled
26 Trials studying Cystic Fibrosis
14,357 Patients Enrolled for Cystic Fibrosis
Tanicia Daley, MD, MPHPrincipal InvestigatorEmory University
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