NCT02630667

Brief Summary

The aim of this study is to investigate the acute effects of ingestion of carbohydrates - with different glycemic profiles - on cognitive function among preadolescent children (i.e., 9-10 years).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

3.9 years

First QC Date

August 25, 2015

Last Update Submit

December 7, 2016

Conditions

Cognitive Ability, GeneralDietary Modification

Outcome Measures

Primary Outcomes (2)

  • Change in Cognitive Control at 15 minutes Postprandial

    Performance will be assessed using the difference in inverse efficiency (during a modified flanker task) between performance at 15 minutes and baseline/fasted (within 2 hours of wake-time) performance.

    15 minutes Postprandial

  • Change in Cognitive Control at 70 minutes Postprandial

    Performance will be assessed using the difference in inverse efficiency (during a modified flanker task) between performance at 70 minutes and baseline/fasted (within 2 hours of wake-time).

    70 minutes Postprandial

Secondary Outcomes (2)

  • Change in Relational Memory at 30 minutes Postprandial

    30 minutes Postprandial

  • Change in Relational Memory at 85 minutes Postprandial

    85 minutes Postprandial

Study Arms (4)

SLOW Carbohydrate

EXPERIMENTAL

Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response.

Other: SLOW Carbohydrate

MEDIUM Carbohydrate

EXPERIMENTAL

Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response.

Other: MEDIUM Carbohydrate

FAST Carbohydrate

EXPERIMENTAL

Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response.

Other: FAST Carbohydrate

Non-Caloric Placebo

PLACEBO COMPARATOR

Non-caloric placebo consisting of artificial sweeteners

Other: SLOW CarbohydrateOther: MEDIUM CarbohydrateOther: FAST Carbohydrate

Interventions

SLOW CarbohydrateOTHER

Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response

Non-Caloric PlaceboSLOW Carbohydrate
MEDIUM CarbohydrateOTHER

Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response

MEDIUM CarbohydrateNon-Caloric Placebo
FAST CarbohydrateOTHER

Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response

FAST CarbohydrateNon-Caloric Placebo

Eligibility Criteria

Age9 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parental/guardian consent.
  • Participants must be between the ages of 9-10 years old at the time of testing age
  • Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
  • Participants must have an IQ \> 85 (IQ \< 85).

You may not qualify if:

  • Prior diagnosis of cognitive or physical disability, including ADHD (severe asthma, epilepsy, and dependence upon a wheelchair/walking aid, and ADHD Rating Scale score below 85%).
  • Use of anti-psychotic, anti-depressant, anti-anxiety medication, as well as those medications used for ADD/ADHD (use of any anti-psychotic, anti-depressant, anti-anxiety, and ADD/ADHD medications).
  • Early pubertal status, as measured by a modified test of the Tanner Staging System (onset of puberty as determined by Tanner).
  • Lactose intolerance
  • Allergies to milk and/or soy
  • Adherence to a strict vegan diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Kinesiology and Community Health

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

  • Walk AM, Raine LB, Kramer AF, Cohen NJ, Hillman CH, Khan NA. Adiposity is related to neuroelectric indices of motor response preparation in preadolescent children. Int J Psychophysiol. 2020 Jan;147:176-183. doi: 10.1016/j.ijpsycho.2019.10.014. Epub 2019 Nov 19.

    PMID: 31756405DERIVED

Study Officials

  • Charles Hillman, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2015

First Posted

December 15, 2015

Study Start

June 1, 2012

Primary Completion

May 1, 2016

Last Updated

December 8, 2016

Record last verified: 2016-12

Locations

US(1)