Added Sugar Intake and Brain Structure and Function (GAINS BRAINS)

June 17, 2025 updated by: University of Kansas Medical Center
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Added Sugars Intake Relationship to Brain Structure
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Added Sugars Intake Relationship to Cognition Specifically Attention Development
Time Frame: 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.
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
Time Frame: 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.
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;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

Center for Children's Healthy Lifestyles & Nutrition

Investigators

  • Principal Investigator: Holly Hull, PhD, The University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2023

Primary Completion (Actual)

July 22, 2024

Study Completion (Actual)

July 22, 2024

Study Registration Dates

First Submitted

August 29, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

July 4, 2025

Last Update Submitted That Met QC Criteria

June 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00149236

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Child Development

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe