Cognitive Ability, GeneralNCT02820805
Dietary Carbohydrate Consumption on Memory Performance and Mood in Children
A study testing Meal Skipping, French fries and Mashed potatoes in people with Cognitive Ability, General, run by Toronto Metropolitan University at 1 site in Canada.
Trial summary
The purpose of this study is to determine the effect of carbohydrates on blood glucose levels, subjective appetite, mood, and memory performance in 9 to 14 year old normal weight (NW) and overweight or obese (OW/OB) children. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Ability, General
- What is being tested?
- Meal Skipping, French fries and Mashed potatoes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Oct 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- be between 9 and 14 years of age
- be healthy, and have been born at term
- be a native English speaker
- not be taking any medications
- not have allergies to potatoes, rice, or beans.
- normal body weight (between the 5th and 85th BMI percentile for age and gender)
- OW/OB (>85th BMI percentile for age and gender)
Who cannot join
- Food sensitivities, allergies, or dietary restrictions
- Health, learning, emotional, or behaivoural problems
- Receiving any medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dietary Carbohydrate Consumption on Memory Performance and Mood in Normal Weight and Overweight/Obese Children
The purpose of this study is to determine the effect of carbohydrates on blood glucose levels, subjective appetite, mood, and memory performance in 9 to 14 year old normal weight (NW) and overweight or obese (OW/OB) children.
Read the detailed description
NW and OW/OB children, 9-14 years of age, will participate in the experiment. The effect of 5 different meals (mashed potatoes, hash browns, French fries, rice, or beans matched by 50g of available carbohydrate) and meal skipping will be examined. On six separate mornings, one of the meals or no meal will be provided in a random order upon their arrival. Blood glucose, subjective appetite, and mood will be measured at baseline, 10, 30, 60, 120, and 180 minutes after meal consumption. Cognitive performance will be measured using an immediate and delayed word recall test, and two to three executive function tasks at 10, 30, 60, 120, and 180 minutes after meal consumption.
- Conditions
- Cognitive Ability, General
- Being tested
- Meal Skipping, French fries, Mashed potatoes, Hash browns, Rice
- Keywords
- children, dietary carbohydrates, solanum tuberosum, cognition, memory, emotions, blood glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal SkippingOther
No meal
French friesOther
50g of available carbohydrates meal
Mashed potatoesOther
50g of available carbohydrates meal
Hash brownsOther
50g of available carbohydrates meal
RiceOther
50g of available carbohydrates meal
BeansOther
50g of available carbohydrates meal
| Study group | Role | What they receive |
|---|---|---|
| Meal skipping | Experimental | No meal given Receives: Other: Meal Skipping |
| Mashed potatoes | Experimental | Carbohydrate Test Meal (50 g of available carbohydrates) Receives: Other: Mashed potatoes |
| French fries | Experimental | Carbohydrate Test Meal (50 g of available carbohydrates) Receives: Other: French fries |
| Hash browns | Experimental | Carbohydrate Test Meal (50 g of available carbohydrates) Receives: Other: Hash browns |
| Rice | Experimental | Carbohydrate Test Meal (50 g of available carbohydrates) Receives: Other: Rice |
| Beans | Experimental | Carbohydrate Test Meal (50 g of available carbohydrates) Receives: Other: Beans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance
Participants will participate in a battery of tests that include two learning and memory tasks and two attention tasks at 10, 30, 60, 120, and 180 minutes after meal consumption.
Measured: 10, 30, 60, 120, 180 minutes after meal consumption
Secondary outcomes (2)
Blood glucose response
Blood will be collected at baseline, 10, 30, 60, 120, and 180 minutes after meal consumption to observe glycemic responses to 50g available carbohydrates from mashed potatoes, potato pancakes, French fries, rice, or beans
Measured: Baseline, 10, 30, 60, 120, and 180 minutes after meal consumption
Subjective Appetite and Mood
Participants will complete subjective ratings on appetite (e.g., desire to eat, hunger, fullness) and mood (e.g. anger, happiness, excitement, sleepiness) at baseline, 10, 30, 60, 120, and 180 minutes after meal consumption.
Measured: Baseline, 10, 30, 60, 120, and 180 minutes after meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nick Bellissimo, Toronto Metropolitan University
- Investigators
- Nick Bellissimo, PhD., Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820805
- Sponsor's protocol ID
- REB2016-060
- Status last verified
- Aug 2017
- First submitted
- 27 Jun 2016
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Carbohydrate Consumption on Memory Performance and Mood in Normal Weight and Overweight/Obese Children
- ClinicalTrials.gov ID
- NCT02820805
- Acronym / sponsor ID
- REB2016-060
- Conditions
- Cognitive Ability, General
- Keywords
- children, dietary carbohydrates, solanum tuberosum, cognition, memory, emotions, blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Jul 2016 (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 purpose of this study is to determine the effect of carbohydrates on blood glucose levels, subjective appetite, mood, and memory performance in 9 to 14 year old normal weight (NW) and overweight or obese (OW/OB) children.
Detailed description
NW and OW/OB children, 9-14 years of age, will participate in the experiment. The effect of 5 different meals (mashed potatoes, hash browns, French fries, rice, or beans matched by 50g of available carbohydrate) and meal skipping will be examined. On six separate mornings, one of the meals or no meal will be provided in a random order upon their arrival. Blood glucose, subjective appetite, and mood will be measured at baseline, 10, 30, 60, 120, and 180 minutes after meal consumption. Cognitive performance will be measured using an immediate and delayed word recall test, and two to three executive function tasks at 10, 30, 60, 120, and 180 minutes after meal consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Meal skipping | Experimental | Other: Meal SkippingNo meal given |
| Mashed potatoes | Experimental | Other: Mashed potatoesCarbohydrate Test Meal (50 g of available carbohydrates) |
| French fries | Experimental | Other: French friesCarbohydrate Test Meal (50 g of available carbohydrates) |
| Hash browns | Experimental | Other: Hash brownsCarbohydrate Test Meal (50 g of available carbohydrates) |
| Rice | Experimental | Other: RiceCarbohydrate Test Meal (50 g of available carbohydrates) |
| Beans | Experimental | Other: BeansCarbohydrate Test Meal (50 g of available carbohydrates) |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- be between 9 and 14 years of age
- be healthy, and have been born at term
- be a native English speaker
- not be taking any medications
- not have allergies to potatoes, rice, or beans.
Key exclusion criteria (3 listed)
- Food sensitivities, allergies, or dietary restrictions
- Health, learning, emotional, or behaivoural problems
- Receiving any medications
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 |
|---|---|---|
| Meal SkippingNo meal | Other | Meal skipping |
| French fries50g of available carbohydrates meal | Other | French fries |
| Mashed potatoes50g of available carbohydrates meal | Other | Mashed potatoes |
| Hash browns50g of available carbohydrates meal | Other | Hash browns |
| Rice50g of available carbohydrates meal | Other | Rice |
| Beans50g of available carbohydrates meal | Other | Beans |
Primary outcome
Cognitive performance
Time frame: 10, 30, 60, 120, 180 minutes after meal consumption
Participants will participate in a battery of tests that include two learning and memory tasks and two attention tasks at 10, 30, 60, 120, and 180 minutes after meal consumption.
2 secondary outcomes
Blood glucose response
Time frame: Baseline, 10, 30, 60, 120, and 180 minutes after meal consumption
Subjective Appetite and Mood
Time frame: Baseline, 10, 30, 60, 120, and 180 minutes after meal consumption
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 9 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Nick Bellissimo, PhD. principal investigator
Toronto Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal Skipping, French fries and Mashed potatoes in people with Cognitive Ability, General, run by Toronto Metropolitan University at 1 site in Canada.
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 7 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 9 Aug 2017. 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 Canada. 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?
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?
Cognitive performance (time frame: 10, 30, 60, 120, 180 minutes after meal consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2017; AzTrials last refreshed its copy on 6 Nov 2026.