Recruiting

High vs Low Glycemic Index

Sponsor:

Emory University

Code:

NCT06350149

Conditions

Cystic Fibrosis

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Not accepted

Interventions

Sugar Sweetened Beverages (SSB)

Hi GI

Lo GI

Study Details

Brief summary:

The goal of this study is to determine the extent to which excess dietary simple sugars serve as a secondary mediating factor in Cystic fibrosis-related diabetes (CFRD) development. The main questions it aims to answer are:

  • Whether conducting a randomized 2x2 factorial design that evaluates acute postprandial changes in glucose over 2 hours following ingestion of a mixed meal challenge that varies by glycemic index and consumption of a sugar-sweetened beverage is acceptable and feasible.
  • What are the preliminary changes in postprandial hyperglycemia, islet cell function, and incretin response to a high or low Glycemic Index mixed meal tolerance test (MMTT) with and without Sugar-Sweetened Beverages (SSB) in adolescents and young adults with CF

Participants will be randomized to a mixed diet and blood will be drawn before and after the mixed meal challenge.

Conditions

Cystic Fibrosis

Study ID

NCT06350149

Start date

Mar 22, 2024

Status verified date

Apr, 2024

Completion date

Sep, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • English speaking
  • Diagnosis of CF based on the presence of two known CF causing mutations and/or positive sweat test
  • Pancreatic insufficiency
  • Baseline dietary consumption of >10% total kcal from added sugars and self-reported consumption of >/= sugar-sweetened beverages per week

Exclusion Criteria:

  • Current use or anticipated use of medication that is known to raise or lower blood glucose in the past 4 weeks.
  • Oral or IV glucocorticoid current or previous use in the past 4 weeks will prohibit enrollment in the study.
  • Recent pulmonary exacerbation within 3 weeks of enrollment and/or an acute illness requiring a change in antibiotics will also exclude participants.
  • BMI below the 5th percentile or greater than the 95th percentile for age and sex
  • FEV1 <40% or awaiting a lung transplant;
  • Prior lung or liver transplant or kidney or liver dysfunction.
  • Use of CFTR modulators is not an exclusion criterion. Rather, for patients recently started on CFTR modulators, we will wait to enroll in the study until on CFTR modulator for at least 2 months.
  • Diagnosis of CF liver disease.
  • Uncontrolled exocrine pancreatic insufficiency/malabsorption
  • Diagnosis of CFRD
  • G-tube feeds (bolus and/or continuous)
  • Current enrollment in another intervention study
  • Changes in diet to lose or gain weight
  • Gluten allergy or intolerance
  • Current pregnancy or lactation or plans to become pregnant during study period
  • History of drug or alcohol abuse
  • Restrictive dietary patterns (e.g, vegan, ketogenic, intermittent fasting) for more than one month within the last two months prior to screening.
  • More than 5% body weight change within 2 months of screening visit or Day 1 of mixed meal tolerance test

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: SSB+ HI- GI

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

experimental: SSB + LO- GI

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

experimental: NSSB+ HI- GI

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

experimental: NSSB+ LO- GI

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

Interventions

Sugar Sweetened Beverages (SSB)

The following are considered SSBs: non-diet soft drinks/sodas, flavored juice drinks, sweetened tea, energy drinks, and electrolyte replacement drinks.

Hi GI

The Glycemic Index of the high-GI meals will be at least 75

Lo GI

The Glycemic Index of the low- -GI meals will not be higher than 55.

Primary outcome measure

  • Recruitment Rate [ Time Frame: 2 years ]
  • Refusal Rate [ Time Frame: 2 years ]
  • Investigator Fidelity [ Time Frame: 2 years ]
  • Participant Fidelity [ Time Frame: 2 years ]
  • Acceptability [ Time Frame: 2 years ]
  • Retention Rates [ Time Frame: 2 years ]
  • Recruitment [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Tanicia Daley, MD, MPH

404-785-5437tanicia.daley@emory.edu

Jocelyn McNeany

jocelyn.villalobos.mcneany@emory.edu

Locations

Center for Advanced Pediatrics: Emory Healthcare

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Tanicia Daley, MD

404-785-5437tanicia.daley@emory.edu

Arlene Stecenko, MD

404-727-1460astecen@emory.edu

Principal Investigator:

Tanicia Daley, MD

More Information

Sponsor

Emory University

Last update posted

Apr 5, 2024

Last verified

Apr, 2024

Keywords

  • Cystic Fibrosis
  • Glycemic Index
  • Cystic Fibrosis Related Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2024-04-05.