Added Sugar Intake and Brain Structure and Function

NCT06640829 | Completed Results

• 1 other identifier: STUDY00149236
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Development

Keywords

Added sugars; Dietary intake; Brain health; Child development

Outcome Measures

Primary Outcomes (4)

• Added Sugars Intake Relationship to Brain Structure

  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.

  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;

• Added Sugars Intake Relationship to Brain Function

  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.

  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;

• Fructose Intake Relationship to Brain Structure

  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.

  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;

• Fructose Intake Relationship to Brain Function

  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.

  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;

Secondary Outcomes (2)

• 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;

• 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;

Study Arms (1)

ADORE GAINS Participants

Children's who participated in the ADORE GAINS study were invited to participate as their body composition and dietary intake was collected during their infancy and toddlerhood.

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Participants received an invitation to participate in this study if they were enrolled in the ADORE GAINS study as an infant and toddler.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Center for Children's Healthy Lifestyles & Nutrition: collaborator

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Results Point of Contact

• Title: Holly Hull
• Organization: The University of Kansas Medical Center

hhull@kumc.edu

9135881000

Study Officials

• Holly Hull, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: October 15, 2024
• Study Start: March 23, 2023
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: July 4, 2025
• Results First Posted: July 4, 2025

Record last verified: 2025-06

Locations

US (1)