Trial Outcomes & Findings for Added Sugar Intake and Brain Structure and Function (NCT NCT06640829)

NCT ID: NCT06640829

Last Updated: 2025-07-04

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

42 participants

Primary outcome timeframe

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;

Results posted on

2025-07-04

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
42
Overall Study
COMPLETED
40
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
Overall Study
Withdrawal by Subject
1
Overall Study
Lost to Follow-up
1

Baseline Characteristics

two participants had incomplete/invalid dietary data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ADORE GAINS Participants
n=42 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.
Age, Continuous
5.77 Years
STANDARD_DEVIATION 0.38 • n=42 Participants
Sex: Female, Male
Female
22 Participants
n=42 Participants
Sex: Female, Male
Male
20 Participants
n=42 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=42 Participants
Race (NIH/OMB)
Asian
0 Participants
n=42 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=42 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=42 Participants
Race (NIH/OMB)
White
28 Participants
n=42 Participants
Race (NIH/OMB)
More than one race
6 Participants
n=42 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
19 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
23 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=42 Participants
Percent of energy (kilocalories) from added sugars at age 5-6 years
13.89 Percentage of kilocalorie intake
STANDARD_DEVIATION 5.52 • n=40 Participants • two participants had incomplete/invalid dietary data
Percent of energy (kilocalories) from fructose at age 5-6 years
4.68 Percentage of kilocalorie intake
STANDARD_DEVIATION 2.05 • n=40 Participants • two participants had incomplete/invalid dietary data

PRIMARY outcome

Timeframe: 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;

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

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.

Outcome measures

Outcome measures
Measure
ADORE GAINS Participants
n=13 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.
Added Sugars Intake Relationship to Brain Structure
Right Hippocampal Volume and Percent of Calories from Added Sugars at age 5-6 years
-0.231 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Structure
Left Hippocampal Volume and Maternal Prenatal Percent of Calories from Added Sugars
-0.045 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Structure
Left Hippocampal Volume and Percent of Calories from Added Sugars at age 5-6 years
0.119 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Structure
Left Hippocampal Volume and Percent of Calories from Added Sugars at age 6 months
0.345 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Structure
Right Hippocampal Volume and Percent of Calories from Added Sugars at age 6 months
0.384 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Structure
Left Hippocampal Volume and Percent of Calories from Added Sugars at age 12 months
0.176 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Structure
Right Hippocampal Volume and Percent of Calories from Added Sugars at age 12 months
-0.202 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Structure
Left Hippocampal Volume and Percent of Calories from Added Sugars at age 24 months
0.242 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Structure
Right Hippocampal Volume and Percent of Calories from Added Sugars at age 24 months
0.016 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Structure
Right Hippocampal Volume and Maternal Prenatal Percent of Calories from Added Sugars
-0.502 Pearson correlation coefficient

PRIMARY outcome

Timeframe: 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;

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

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.

Outcome measures

Outcome measures
Measure
ADORE GAINS Participants
n=18 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.
Added Sugars Intake Relationship to Brain Function
Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 5-6 years
0.059 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
No-Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 6 months
0.404 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 24 months
0.028 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
Go Trials P3 Amplitude and Maternal Prenatal Percent of Calories from Added Sugars
-0.285 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
No-Go Trials P3 Amplitude and Maternal Prenatal Percent of Calories from Added Sugars
-0.224 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
No-Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 5-6 years
-0.016 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 5-6 years
-0.045 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
No-Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 5-6 years
0.090 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 6 months
0.481 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 6 months
-0.183 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
No-Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 6 months
-0.095 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 12 months
0.534 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
No-Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 12 months
0.459 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 12 months
-0.358 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
No-Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 12 months
-0.176 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 24 months
-0.083 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
No-Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 24 months
-0.088 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
No-Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 24 months
-0.042 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
Go Trials N2 Amplitude and Maternal Prenatal Percent of Calories from Added Sugars
0.051 Pearson correlation coefficient
Added Sugars Intake Relationship to Brain Function
No-Go Trials N2 Amplitude and Maternal Prenatal Percent of Calories from Added Sugars
0.120 Pearson correlation coefficient

PRIMARY outcome

Timeframe: 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;

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

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.

Outcome measures

Outcome measures
Measure
ADORE GAINS Participants
n=13 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.
Fructose Intake Relationship to Brain Structure
Left Hippocampal Volume and Percent of Calories from Fructose at age 5-6 years
-0.220 Pearson correlation coefficient
Fructose Intake Relationship to Brain Structure
Left Hippocampal Volume and Percent of Calories from Fructose at age 24 months
-0.389 Pearson correlation coefficient
Fructose Intake Relationship to Brain Structure
Right Hippocampal Volume and Percent of Calories from Fructose at age 24 months
-0.213 Pearson correlation coefficient
Fructose Intake Relationship to Brain Structure
Left Hippocampal Volume and Maternal Prenatal Percent of Calories from Fructose
-0.252 Pearson correlation coefficient
Fructose Intake Relationship to Brain Structure
Right Hippocampal Volume and Maternal Prenatal Percent of Calories from Fructose
-0.466 Pearson correlation coefficient
Fructose Intake Relationship to Brain Structure
Right Hippocampal Volume and Percent of Calories from Fructose at age 5-6 years
-0.413 Pearson correlation coefficient
Fructose Intake Relationship to Brain Structure
Left Hippocampal Volume and Percent of Calories from Fructose at age 6 months
-0.730 Pearson correlation coefficient
Fructose Intake Relationship to Brain Structure
Right Hippocampal Volume and Percent of Calories from Fructose at age 6 months
-0.071 Pearson correlation coefficient
Fructose Intake Relationship to Brain Structure
Left Hippocampal Volume and Percent of Calories from Fructose at age 12 months
0.132 Pearson correlation coefficient
Fructose Intake Relationship to Brain Structure
Right Hippocampal Volume and Percent of Calories from Fructose at age 12 months
-0.535 Pearson correlation coefficient

PRIMARY outcome

Timeframe: 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;

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

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.

Outcome measures

Outcome measures
Measure
ADORE GAINS Participants
n=18 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.
Fructose Intake Relationship to Brain Function
Go Trials N2 Amplitude and Percent of Calories from Fructose at age 5-6 years
-0.014 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
No-Go Trials N2 Amplitude and Percent of Calories from Fructose at age 5-6 years
0.018 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
Go Trials P3 Amplitude and Percent of Calories from Fructose at age 5-6 years
-0.129 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
No-Go Trials P3 Amplitude and Percent of Calories from Fructose at age 5-6 years
-0.275 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
Go Trials N2 Amplitude and Percent of Calories from Fructose at age 6 months
-0.555 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
No-Go Trials N2 Amplitude and Percent of Calories from Fructose at age 6 months
-0.331 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
Go Trials P3 Amplitude and Percent of Calories from Fructose at age 6 months
0.355 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
No-Go Trials P3 Amplitude and Percent of Calories from Fructose at age 6 months
0.416 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
Go Trials N2 Amplitude and Percent of Calories from Fructose at age 12 months
0.057 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
No-Go Trials N2 Amplitude and Percent of Calories from Fructose at age 12 months
0.152 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
Go Trials P3 Amplitude and Percent of Calories from Fructose at age 12 months
0.045 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
No-Go Trials P3 Amplitude and Percent of Calories from Fructose at age 12 months
0.040 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
Go Trials N2 Amplitude and Percent of Calories from Fructose at age 24 months
-0.116 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
No-Go Trials N2 Amplitude and Percent of Calories from Fructose at age 24 months
-0.110 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
Go Trials P3 Amplitude and Percent of Calories from Fructose at age 24 months
0.050 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
No-Go Trials P3 Amplitude and Percent of Calories from Fructose at age 24 months
0.076 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
Go Trials N2 Amplitude and Maternal Prenatal Percent of Calories from Fructose
0.414 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
No-Go Trials N2 Amplitude and Maternal Prenatal Percent of Calories from Fructose
0.507 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
Go Trials P3 Amplitude and Maternal Prenatal Percent of Calories from Fructose
-0.463 Pearson correlation coefficient
Fructose Intake Relationship to Brain Function
No-Go Trials P3 Amplitude and Maternal Prenatal Percent of Calories from Fructose
-0.600 Pearson correlation coefficient

SECONDARY outcome

Timeframe: 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;

Population: three participants either had incomplete/invalid dietary data and/or did not complete the cognitive test

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.

Outcome measures

Outcome measures
Measure
ADORE GAINS Participants
n=39 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.
Added Sugars Intake Relationship to Cognition Specifically Attention Development
DCCS Post-Switch Score and Percent of Calories from Added Sugars at age 12 months
0.020 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Attention Development
DCCS Pre-Switch Score and Percent of Calories from Added Sugars at age 5-6 years
0.163 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Attention Development
DCCS Borders Score and Percent of Calories from Added Sugars at age 6 months
-0.259 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Attention Development
DCCS Pre-Switch Score and Percent of Calories from Added Sugars at age 12 months
0.151 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Attention Development
DCCS Borders Score and Percent of Calories from Added Sugars at age 12 months
0.037 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Attention Development
DCCS Pre-Switch Score and Percent of Calories from Added Sugars at age 24 months
0.001 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Attention Development
DCCS Post-Switch Score and Percent of Calories from Added Sugars at age 5-6 years
-0.076 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Attention Development
DCCS Borders Score and Percent of Calories from Added Sugars at age 5-6 years
-0.031 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Attention Development
DCCS Post-Switch Score and Percent of Calories from Added Sugars at age 6 months
-0.374 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Attention Development
DCCS Post-Switch Score and Percent of Calories from Added Sugars at age 24 months
-0.283 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Attention Development
DCCS Borders Score and Percent of Calories from Added Sugars at age 24 months
-0.108 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Attention Development
DCCS Pre-Switch Score and Maternal Prenatal Percent of Calories from Added Sugars
0.171 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Attention Development
DCCS Post-Switch Score and Maternal Prenatal Percent of Calories from Added Sugars
-0.324 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Attention Development
DCCS Borders Score and Maternal Prenatal Percent of Calories from Added Sugars
-0.023 Pearson correlation coefficient

SECONDARY outcome

Timeframe: 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;

Population: three participants either had incomplete/invalid dietary data and/or did not complete the cognitive test

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.

Outcome measures

Outcome measures
Measure
ADORE GAINS Participants
n=39 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.
Added Sugars Intake Relationship to Cognition Specifically Vocabulary Receptiveness
PPVT Percentile and Percent of Calories from Added Sugars at age 24 months
-0.150 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Vocabulary Receptiveness
PPVT Standard Score and Maternal Prenatal Percent of Calories from Added Sugars
-0.045 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Vocabulary Receptiveness
PPVT Standard Score and Percent of Calories from Added Sugars at age 5-6 years
0.118 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Vocabulary Receptiveness
PPVT Percentile and Percent of Calories from Added Sugars at age 5-6 years
0.124 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Vocabulary Receptiveness
PPVT Standard Score and Percent of Calories from Added Sugars at age 6 months
0.062 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Vocabulary Receptiveness
PPVT Percentile and Percent of Calories from Added Sugars at age 6 months
0.020 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Vocabulary Receptiveness
PPVT Standard Score and Percent of Calories from Added Sugars at age 12 months
0.035 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Vocabulary Receptiveness
PPVT Percentile and Percent of Calories from Added Sugars at age 12 months
0.043 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Vocabulary Receptiveness
PPVT Standard Score and Percent of Calories from Added Sugars at age 24 months
-0.092 Pearson correlation coefficient
Added Sugars Intake Relationship to Cognition Specifically Vocabulary Receptiveness
PPVT Percentile and Maternal Prenatal Percent of Calories from Added Sugars
-0.126 Pearson correlation coefficient

Adverse Events

ADORE GAINS Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Holly Hull

The University of Kansas Medical Center

Phone: 9135881000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place