Added Sugar Intake and Brain Structure and Function

Active, not recruiting

• Conditions: Child Development

• Registration Number: NCT06640829
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

The purpose of this study is to learn if there is a relationship between added sugar intake during pregnancy, infancy, and toddlerhood and the brain's structure and function at 5-6 years old.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-23
• Status Verified: 2024-08
• Study First Submitted: 2024-08-29
• Study First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Participated in the ADORE GAINS study (R01 DK118220).
• Age at participation 5-6 years old.

Exclusion Criteria

• Did not participated in the ADORE GAINS study.
• Younger than 5 and older than 6.
• Autism diagnosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Added sugars intake relationship to brain structure	5-6 years old	Assess the impact of added sugars intake measured by 24-hour dietary intake to the brain's structure via an MRI 3D MPRAGE and fMRI sequencing.
Added sugars intake relationship to brain function	5-6 years old	Assess the impact of added sugars intake measured by 24-hour dietary intake to the brain's function via an EEG task to identify brain activity related to inhibitory control.
Fructose intake relationship to brain structure	5-6 years old	Assess the impact of fructose intake measured by 24-hour dietary intake to the brain's structure and function via an MRI 3D MPRAGE and fMRI sequencing.
Fructose intake relationship to brain function	5-6 years old	Assess the impact of fructose intake measured by 24-hour dietary intake to the brain's structure and function via an EEG task to identify brain activity related to inhibitory control.

Secondary Outcome Measures

Name	Time	Method
Added sugars intake relationship to cognition specifically attention development	5-6 years old	Assess the impact of added sugars intake measured by 24-hour dietary intake to the brain's cognition via a Dimensional Change Card Sort task measuring attention development.
Added sugars intake relationship to cognition specifically vocabulary receptiveness	5-6 years old	Assess the impact of added sugars intake measured by 24-hour dietary intake to the brain's cognition via Peabody Picture Vocabulary Test measuring vocabulary receptiveness.

Trial Locations

Locations (1)

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States