Added Sugar Intake and Brain Structure and Function

Completed

• 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
• Primary Completion: 2024-07-22
• Study Completion: 2024-07-22
• Study First Submitted: 2024-08-29
• Study First Submitted QC: 2024-10-11
• Study First Posted: 2024-10-15
• Results First Submitted: 2025-05-23
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Results First Posted: 2025-07-04
• Last Update Posted: 2025-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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	Day 1 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study;	Assess the impact of added sugars intake measured by 24-hour dietary intake on brain structure, quantified as brain volume, via an MRI 3D MPRAGE and fMRI sequencing. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study.
Fructose Intake Relationship to Brain Structure	Day 1 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study;	Assess the impact of fructose intake measured by 24-hour dietary intake on brain structure, quantified as brain volume, via an MRI 3D MPRAGE and fMRI sequencing. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study.
Added Sugars Intake Relationship to Brain Function	Day 1 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study;	Assess the impact of added sugars intake measured by 24-hour dietary intake on the brain's function via EEG (task-based (Go/NoGo task) event-related potentials (ERPs)) to identify brain activity related to inhibitory control, quantified by amplitude for the Go and NoGo conditions. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study.
Fructose Intake Relationship to Brain Function	Day 1 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study;	Assess the impact of fructose intake measured by 24-hour dietary intake on the brain's function via EEG (task-based (Go/NoGo task) event-related potentials (ERPs)) to identify brain activity related to inhibitory control, quantified by amplitude for the Go and NoGo conditions. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study.

Secondary Outcome Measures

Name	Time	Method
Added Sugars Intake Relationship to Cognition Specifically Attention Development	Day 7 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study;	Assess the impact of added sugars intake measured by 24-hour dietary intake on cognition via a Dimensional Change Card Sort (DCCS) task measuring attention development. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study.
Added Sugars Intake Relationship to Cognition Specifically Vocabulary Receptiveness	Day 7 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study;	Assess the impact of added sugars intake measured by 24-hour dietary intake on cognition via Peabody Picture Vocabulary Test measuring vocabulary receptiveness. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study.

Trial Locations

Locations (1)

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