Cognitive Ability, GeneralNCT02630667
The Acute Effects Fortified Nutritional Supplementation on Childhood Cognition
A study testing SLOW Carbohydrate, MEDIUM Carbohydrate and FAST Carbohydrate in people with Cognitive Ability, General and Dietary Modification, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 9 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Ability, General, Dietary Modification
- What is being tested?
- SLOW Carbohydrate, MEDIUM Carbohydrate and FAST Carbohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 9 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Kinesiology and Community Health
Urbana, Illinois, 61801
About this study
Official title: The Acute Effects of Fortified Nutritional Supplementation on Cognition, Memory, & Achievement
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).
Read the detailed description
Regular breakfast consumption is linked to improved cognitive performance in school-aged children. However, the acute benefits of defined nutrient consumption on brain and cognitive health are not well understood, particularly in preadolescent children. One factor that may relate to brain health and learning in children is the contribution of carbohydrates to the digestion rate of a meal (and associated effects on post-prandial glycemia).
The effects of differentially absorbed carbohydrates on brain and cognition are unknown, especially when ingested via a fortified nutritional beverage providing a balanced array of nutrients. The aim of this study is to investigate the acute, transient effect of nutrient supplementation with varied carbohydrate systems in preadolescent children (i.e., 9-10 years).
Participants will be randomized to receive one of three treatment nutritional formulations containing carbohydrates with varying absorption rates along with a non-caloric placebo. Participants will perform a cognitive battery in the fasted condition, shortly after treatment ingestion, and an hour after ingestion. Group differences in performance will be contrasted to assess the effects of different carbohydrate types on children's cognitive function following an overnight fast.
Findings from this study will inform our understanding of the macronutrient profile of breakfast that may potentially improve children's cognitive performance in the morning.
- Conditions
- Cognitive Ability, General, Dietary Modification
- Being tested
- SLOW Carbohydrate, MEDIUM Carbohydrate, FAST Carbohydrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLOW CarbohydrateOther
Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response
MEDIUM CarbohydrateOther
Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response
FAST CarbohydrateOther
Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response
| Study group | Role | What they receive |
|---|---|---|
| SLOW Carbohydrate | Experimental | Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response. Receives: Other: SLOW Carbohydrate |
| MEDIUM Carbohydrate | Experimental | Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response. Receives: Other: MEDIUM Carbohydrate |
| FAST Carbohydrate | Experimental | Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response. Receives: Other: FAST Carbohydrate |
| Non-Caloric Placebo | Placebo comparator | Non-caloric placebo consisting of artificial sweeteners Receives: Other: SLOW Carbohydrate; Other: MEDIUM Carbohydrate; Other: FAST Carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 70 minutes Postprandial
Secondary outcomes (2)
Change in Relational Memory at 30 minutes Postprandial
Performance will be assessed using the difference in number of swap errors (during a spatial reconstruction task) by calculating the difference between number of errors performed at baseline/fasted (within 2 hours of wake-time) from number of errors at 30 minutes postprandial.
Measured: 30 minutes Postprandial
Change in Relational Memory at 85 minutes Postprandial
Performance will be assessed using the difference in number of swap errors (during a spatial reconstruction task) by calculating the difference between number of errors performed at baseline/fasted (within 2 hours of wake-time) from number of errors at 85 minutes postprandial.
Measured: 85 minutes Postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startJun 2012
- Primary completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive Ability, GeneralStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Nutrition
- Responsible party
- Sponsor
- Investigators
- Charles Hillman, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630667
- Sponsor's protocol ID
- 12641
- Status last verified
- Dec 2016
- First submitted
- 25 Aug 2015
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31756405
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Fortified Nutritional Supplementation on Cognition, Memory, & Achievement
- ClinicalTrials.gov ID
- NCT02630667
- Acronym / sponsor ID
- 12641
- Conditions
- Cognitive Ability, General, Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Abbott Nutrition
- Study start
- Jun 2012
- Primary completion
- May 2016 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Regular breakfast consumption is linked to improved cognitive performance in school-aged children. However, the acute benefits of defined nutrient consumption on brain and cognitive health are not well understood, particularly in preadolescent children. One factor that may relate to brain health and learning in children is the contribution of carbohydrates to the digestion rate of a meal (and associated effects on post-prandial glycemia).
The effects of differentially absorbed carbohydrates on brain and cognition are unknown, especially when ingested via a fortified nutritional beverage providing a balanced array of nutrients. The aim of this study is to investigate the acute, transient effect of nutrient supplementation with varied carbohydrate systems in preadolescent children (i.e., 9-10 years).
Participants will be randomized to receive one of three treatment nutritional formulations containing carbohydrates with varying absorption rates along with a non-caloric placebo. Participants will perform a cognitive battery in the fasted condition, shortly after treatment ingestion, and an hour after ingestion. Group differences in performance will be contrasted to assess the effects of different carbohydrate types on children's cognitive function following an overnight fast.
Findings from this study will inform our understanding of the macronutrient profile of breakfast that may potentially improve children's cognitive performance in the morning.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SLOW Carbohydrate | Experimental | Other: SLOW CarbohydrateTreatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response. |
| MEDIUM Carbohydrate | Experimental | Other: MEDIUM CarbohydrateTreatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response. |
| FAST Carbohydrate | Experimental | Other: FAST CarbohydrateTreatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response. |
| Non-Caloric Placebo | Placebo comparator | Other: SLOW Carbohydrate, Other: MEDIUM Carbohydrate, Other: FAST CarbohydrateNon-caloric placebo consisting of artificial sweeteners |
Who may qualify
- Ages
- 9 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLOW CarbohydrateTreatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response | Other | Non-Caloric Placebo, SLOW Carbohydrate |
| MEDIUM CarbohydrateTreatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response | Other | MEDIUM Carbohydrate, Non-Caloric Placebo |
| FAST CarbohydrateTreatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response | Other | FAST Carbohydrate, Non-Caloric Placebo |
Primary outcome
Change in Cognitive Control at 15 minutes Postprandial
Time frame: 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.
Change in Cognitive Control at 70 minutes Postprandial
Time frame: 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).
2 secondary outcomes
Change in Relational Memory at 30 minutes Postprandial
Time frame: 30 minutes Postprandial
Change in Relational Memory at 85 minutes Postprandial
Time frame: 85 minutes Postprandial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Derived from this study: PubMed 31756405Walk 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.
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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.
Charles Hillman, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLOW Carbohydrate, MEDIUM Carbohydrate and FAST Carbohydrate in people with Cognitive Ability, General and Dietary Modification, run by University of Illinois at Urbana-Champaign 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 4 inclusion and 6 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 8 Dec 2016. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Cognitive Control at 15 minutes Postprandial (time frame: 15 minutes Postprandial). The study lists 2 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 NCT02630667, which also lists 1 linked publication.
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 8 Dec 2016.