Child DevelopmentGAINS BRAINSNCT06640829

Added Sugar Intake and Brain Structure and Function

An observational study of Child Development, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 5 to 6 yearsHealthy volunteers can take part
Conditions the study is for: Child Development
How many people: 42 participants
Where: 1 siteUnited States
Study dates: 23 Mar 2023to 22 Jul 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 6 years
All sexes
Healthy volunteers accepted
Child

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Kansas Medical Center
Kansas City, Kansas, 66160

Other trials in United States

About this study

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06640829
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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;

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Mar 202322 Jul 2024

First posted15 Oct 2024
Study start23 Mar 2023
Primary completion22 Jul 2024
Study completion22 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Child DevelopmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06640829
Sponsor's protocol ID: STUDY00149236
Acronym: GAINS BRAINS
Status last verified: Jun 2025
First submitted: 29 Aug 2024
Last updated: 4 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Added Sugar Intake and Brain Structure and Function
ClinicalTrials.gov ID: NCT06640829
Acronym / sponsor ID: GAINS BRAINS / STUDY00149236
Conditions: Child Development
Keywords: Added sugars, Dietary intake, Brain health, Child development
Study type: Observational
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: University of Kansas Medical CenterUniversity, hospital or other
Collaborators: Center for Children's Healthy Lifestyles & Nutrition
Study start: 23 Mar 2023 (actual)
Primary completion: 22 Jul 2024 (actual)
Study completion: 22 Jul 2024 (actual)
First posted: 15 Oct 2024 (actual)
Results: Posted 4 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
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.

Who may qualify

Ages: 5 to 6 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child
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.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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.
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.
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.

2 secondary outcomes

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;
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;

Results and safety

Results posted to the registry on 4 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ADORE GAINS Participants	42	40

Primary outcome: 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;. Number. Unit: Pearson correlation coefficient

Measure	ADORE GAINS Participants n = 13
Left Hippocampal Volume and Percent of Calories from Added Sugars at age 5-6 years	0.119
Right Hippocampal Volume and Percent of Calories from Added Sugars at age 5-6 years	-0.231
Left Hippocampal Volume and Percent of Calories from Added Sugars at age 6 months	0.345
Right Hippocampal Volume and Percent of Calories from Added Sugars at age 6 months	0.384
Left Hippocampal Volume and Percent of Calories from Added Sugars at age 12 months	0.176
Right Hippocampal Volume and Percent of Calories from Added Sugars at age 12 months	-0.202
Left Hippocampal Volume and Percent of Calories from Added Sugars at age 24 months	0.242
Right Hippocampal Volume and Percent of Calories from Added Sugars at age 24 months	0.016

Population analysed: only 13 participants had complete/valid dietary data and usable MRI data

Primary outcome: Added Sugars Intake Relationship to Brain Function

Measure	ADORE GAINS Participants n = 18
Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 5-6 years	0.059
No-Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 5-6 years	-0.016
Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 5-6 years	-0.045
No-Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 5-6 years	0.090
Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 6 months	0.481
No-Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 6 months	0.404
Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 6 months	-0.183
No-Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 6 months	-0.095

Population analysed: only 18 participants had both complete/valid dietary data and EEG data

Primary outcome: Fructose Intake Relationship to Brain Structure

Measure	ADORE GAINS Participants n = 13
Left Hippocampal Volume and Percent of Calories from Fructose at age 5-6 years	-0.220
Right Hippocampal Volume and Percent of Calories from Fructose at age 5-6 years	-0.413
Left Hippocampal Volume and Percent of Calories from Fructose at age 6 months	-0.730
Right Hippocampal Volume and Percent of Calories from Fructose at age 6 months	-0.071
Left Hippocampal Volume and Percent of Calories from Fructose at age 12 months	0.132
Right Hippocampal Volume and Percent of Calories from Fructose at age 12 months	-0.535
Left Hippocampal Volume and Percent of Calories from Fructose at age 24 months	-0.389
Right Hippocampal Volume and Percent of Calories from Fructose at age 24 months	-0.213

Population analysed: only 13 participants had complete/valid dietary data and usable MRI data

Primary outcome: Fructose Intake Relationship to Brain Function

Measure	ADORE GAINS Participants n = 18
Go Trials N2 Amplitude and Percent of Calories from Fructose at age 5-6 years	-0.014
No-Go Trials N2 Amplitude and Percent of Calories from Fructose at age 5-6 years	0.018
Go Trials P3 Amplitude and Percent of Calories from Fructose at age 5-6 years	-0.129
No-Go Trials P3 Amplitude and Percent of Calories from Fructose at age 5-6 years	-0.275
Go Trials N2 Amplitude and Percent of Calories from Fructose at age 6 months	-0.555
No-Go Trials N2 Amplitude and Percent of Calories from Fructose at age 6 months	-0.331
Go Trials P3 Amplitude and Percent of Calories from Fructose at age 6 months	0.355
No-Go Trials P3 Amplitude and Percent of Calories from Fructose at age 6 months	0.416

Population analysed: only 18 participants had both complete/valid dietary data and EEG data

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Collected for the duration of study visits, an average of 7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ADORE GAINS Participants	0 of 42 (0%)	0 of 42 (0%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Holly Hull, PhD principal investigator

University of Kansas Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Child Development, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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;). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06640829.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.