Glycemic ResponseNCT03305107
High-intensity Interval Exercise and Chocolate Milk on Blood Glucose and Cognition
A study testing Exercise and Chocolate Milk, Exercise and Water and Sitting and Chocolate Milk in people with Glycemic Response and Cognitive Function, run by Toronto Metropolitan University at 1 site in Canada.
Trial summary
The purpose of this study is to determine the separate and combined effects of high-intensity interval exercise and chocolate milk on glycemic response, cognitive function, subjective appetite, and salivary cortisol among children aged 9-13 year old children. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response, Cognitive Function
- What is being tested?
- Exercise and Chocolate Milk, Exercise and Water and Sitting and Chocolate Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jul 2017to 31 May 2018
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- be between 9 and 13 years of age
- be healthy, and have been born at term
- not be taking any medications
- not have allergies to dairy or gluten.
Who cannot join
- Food sensitivities, allergies, or dietary restrictions
- Health, learning, emotional, or behavioural problems
- Receiving any medications
- Non-habitual breakfast eater (<5 days/week)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of High-intensity Interval Exercise and Chocolate Milk on Glycemic Control and Cognitive Function in Children.
The purpose of this study is to determine the separate and combined effects of high-intensity interval exercise and chocolate milk on glycemic response, cognitive function, subjective appetite, and salivary cortisol among children aged 9-13 year old children.
Read the detailed description
Twenty children 9-13 years of age will be recruited for this study. On four separate mornings, after a 10 hour overnight fast, each child will consume a standardized breakfast (including orange juice, a strawberry breakfast bar and a pear fruit cup) at home. Using a 2x2 factorial design, 2 hours after breakfast consumption, each participant will arrive in the lab (T=-20 min) and participate in high-intensity interval exercise or sit quietly for 20 min, followed by a treatment drink of chocolate milk or water (control) consumption in 10 min. During high-intensity interval exercise treatment, children will exercise on a cycle ergometer with a 3-min warm-up, 7 repeated bouts of 60-sec exercise at 90% of peak power output and 60-second recovery, and a 3-min cool down. Blood glucose will be measured via finger-prick at baseline (-20 min), 10, 30, 60, and 90 min. Cognitive functions will be measured using a battery of cognitive tests which assess verbal declarative memory, working memory, and executive functioning, and will be measured at baseline, 10. 30. 60, and 90 min. Subjective appetite and emotions will be measured using a 100-mm visual analogue scale (VAS) at baseline, 10, 30, 60, and 90 min. Salivary cortisol will be assessed from saliva samples collected using the passive drool method, and will be collected at baseline, 10 and 30 min.
- Conditions
- Glycemic Response, Cognitive Function
- Being tested
- Exercise and Chocolate Milk, Exercise and Water, Sitting and Chocolate Milk, Sitting and Water
- Keywords
- Child, Exercise, Chocolate milk, Blood glucose, Cognition, Appetite, Emotions, Cortisol
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and Chocolate MilkOther
High intensity interval exercise Chocolate Milk
Exercise and WaterOther
High intensity interval exercise Water
Sitting and Chocolate MilkOther
Sitting Chocolate Milk
Sitting and WaterOther
Sitting Water
| Study group | Role | What they receive |
|---|---|---|
| Exercise and Chocolate Milk | Experimental | Children will exercise on a cycle ergometer with a 3-min warm-up, 7 repeated bouts of 60-sec exercise at 90% of peak power output and 60-second recovery, and a 3-min cool down.
Children will then drink 240mL of chocolate milk Receives: Other: Exercise and Chocolate Milk |
| Exercise and Water | Experimental | Children will exercise on a cycle ergometer with a 3-min warm-up, 7 repeated bouts of 60-sec exercise at 90% of peak power output and 60-second recovery, and a 3-min cool down.
Children will then drink 240mL of water Receives: Other: Exercise and Water |
| Sitting and Chocolate Milk | Experimental | Children will quietly sit for 20 minutes Children will then drink 240mL of chocolate milk Receives: Other: Sitting and Chocolate Milk |
| Sitting and Water | Experimental | Children will quietly sit for 20 minutes Children will then drink 240mL of water Receives: Other: Sitting and Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Glycemic Response
Blood samples will be collected via finger-prick method to assess glycemic response (blood glucose, mmol/L)
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline verbal declarative memory
Cognitive function test of verbal declarative memory
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline working memory
The n-back test consists of 2 levels, 1-back and 2-back, where letters are presented on the screen one at a time. During the 1-back level, participants need to determine if the presented letter is the same as the one letter presented 1 before it or not (by selected 'match' or 'no match' on the side of the screen) and during 2-back need to do determine if it is the same letter as the one presented 2 letters prior.
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline executive functioning
The Stroop test consists of one word appearing on the screen written in either blue, red, yellow or green. There are 24 congruent trials where the presented word is the name of the colour it is written it (i.e. 'red' appearing in the colour red), 24 incongruent trials where the word written is a colour word different from the one it is written in (i.e. 'red' appearing in the colour green), and 10 neutral trials where non-colour words appear (i.e. 'tape' appearing in yellow). The participant is asked to tap the corresponding colour that the word is written in as quickly as possible.
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Secondary outcomes (14)
Change from baseline salivary cortisol response
Saliva samples will be collected via passive drool method to assess salivary cortisol response (ug/dL)
Measured: baseline (-20 min), and 10 and 30 min post-drink consumption
Change form baseline Subjective Appetite
100-mm Visual Analogue Scales (VAS) will be used to assess appetite
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline aggression
100-mm Visual Analogue Scales (VAS) will be used to assess aggression
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline anger
100-mm Visual Analogue Scales (VAS) will be used to assess anger
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline excitement
100-mm Visual Analogue Scales (VAS) will be used to assess excitement
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline disappointment
100-mm Visual Analogue Scales (VAS) will be used to assess disappointment
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline happiness
100-mm Visual Analogue Scales (VAS) will be used to assess happiness
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline upset
100-mm Visual Analogue Scales (VAS) will be used to assess upset
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change form baseline frustration
100-mm Visual Analogue Scales (VAS) will be used to assess frustration
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline alertness
100-mm Visual Analogue Scales (VAS) will be used to assess alertness
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline sadness
100-mm Visual Analogue Scales (VAS) will be used to assess sadness
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline tension
100-mm Visual Analogue Scales (VAS) will be used to assess tension
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline exhaustion
100-mm Visual Analogue Scales (VAS) will be used to assess exhaustion
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline sleepiness
100-mm Visual Analogue Scales (VAS) will be used to assess sleepiness
Measured: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start8 Jul 2017
- Primary completion31 Dec 2017
- Study completion31 May 2018
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 Glycemic ResponseStudies 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
- 20 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, Study director, School of Nutrition, Ryerson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305107
- Sponsor's protocol ID
- REB2017- 088
- Status last verified
- Aug 2018
- First submitted
- 29 Sep 2017
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kucab M, Bellissimo N, Prusky C, Brett NR, Totosy de Zepetnek JO. Effects of a high-intensity interval training session and chocolate milk on appetite and cognitive performance in youth aged 9-13 years. Eur J Clin Nutr. 2021 Jan;75(1):172-179. doi: 10.1038/s41430-020-00718-z. Epub 2020 Aug 19.
PubMed 32814852
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High-intensity Interval Exercise and Chocolate Milk on Glycemic Control and Cognitive Function in Children.
- ClinicalTrials.gov ID
- NCT03305107
- Acronym / sponsor ID
- REB2017- 088
- Conditions
- Glycemic Response, Cognitive Function
- Keywords
- Child, Exercise, Chocolate milk, Blood glucose, Cognition, Appetite, Emotions, Cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Study start
- 8 Jul 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 9 Oct 2017 (actual)
- 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 separate and combined effects of high-intensity interval exercise and chocolate milk on glycemic response, cognitive function, subjective appetite, and salivary cortisol among children aged 9-13 year old children.
Detailed description
Twenty children 9-13 years of age will be recruited for this study. On four separate mornings, after a 10 hour overnight fast, each child will consume a standardized breakfast (including orange juice, a strawberry breakfast bar and a pear fruit cup) at home. Using a 2x2 factorial design, 2 hours after breakfast consumption, each participant will arrive in the lab (T=-20 min) and participate in high-intensity interval exercise or sit quietly for 20 min, followed by a treatment drink of chocolate milk or water (control) consumption in 10 min. During high-intensity interval exercise treatment, children will exercise on a cycle ergometer with a 3-min warm-up, 7 repeated bouts of 60-sec exercise at 90% of peak power output and 60-second recovery, and a 3-min cool down. Blood glucose will be measured via finger-prick at baseline (-20 min), 10, 30, 60, and 90 min. Cognitive functions will be measured using a battery of cognitive tests which assess verbal declarative memory, working memory, and executive functioning, and will be measured at baseline, 10. 30. 60, and 90 min. Subjective appetite and emotions will be measured using a 100-mm visual analogue scale (VAS) at baseline, 10, 30, 60, and 90 min. Salivary cortisol will be assessed from saliva samples collected using the passive drool method, and will be collected at baseline, 10 and 30 min.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise and Chocolate Milk | Experimental | Other: Exercise and Chocolate MilkChildren will exercise on a cycle ergometer with a 3-min warm-up, 7 repeated bouts of 60-sec exercise at 90% of peak power output and 60-second recovery, and a 3-min cool down. Children will then drink 240mL of chocolate milk |
| Exercise and Water | Experimental | Other: Exercise and WaterChildren will exercise on a cycle ergometer with a 3-min warm-up, 7 repeated bouts of 60-sec exercise at 90% of peak power output and 60-second recovery, and a 3-min cool down. Children will then drink 240mL of water |
| Sitting and Chocolate Milk | Experimental | Other: Sitting and Chocolate MilkChildren will quietly sit for 20 minutes Children will then drink 240mL of chocolate milk |
| Sitting and Water | Experimental | Other: Sitting and WaterChildren will quietly sit for 20 minutes Children will then drink 240mL of water |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- be between 9 and 13 years of age
- be healthy, and have been born at term
- not be taking any medications
- not have allergies to dairy or gluten.
Key exclusion criteria (4 listed)
- Food sensitivities, allergies, or dietary restrictions
- Health, learning, emotional, or behavioural problems
- Receiving any medications
- Non-habitual breakfast eater (<5 days/week)
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 |
|---|---|---|
| Exercise and Chocolate MilkHigh intensity interval exercise Chocolate Milk | Other | Exercise and Chocolate Milk |
| Exercise and WaterHigh intensity interval exercise Water | Other | Exercise and Water |
| Sitting and Chocolate MilkSitting Chocolate Milk | Other | Sitting and Chocolate Milk |
| Sitting and WaterSitting Water | Other | Sitting and Water |
Primary outcome
Change from baseline Glycemic Response
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Blood samples will be collected via finger-prick method to assess glycemic response (blood glucose, mmol/L)
Change from baseline verbal declarative memory
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Cognitive function test of verbal declarative memory
Change from baseline working memory
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
The n-back test consists of 2 levels, 1-back and 2-back, where letters are presented on the screen one at a time. During the 1-back level, participants need to determine if the presented letter is the same as the one letter presented 1 before it or not (by selected 'match' or 'no match' on the side of the screen) and during 2-back need to do determine if it is the same letter as the one presented 2 letters prior.
Change from baseline executive functioning
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
The Stroop test consists of one word appearing on the screen written in either blue, red, yellow or green. There are 24 congruent trials where the presented word is the name of the colour it is written it (i.e. 'red' appearing in the colour red), 24 incongruent trials where the word written is a colour word different from the one it is written in (i.e. 'red' appearing in the colour green), and 10 neutral trials where non-colour words appear (i.e. 'tape' appearing in yellow). The participant is asked to tap the corresponding colour that the word is written in as quickly as possible.
14 secondary outcomes
Change from baseline salivary cortisol response
Time frame: baseline (-20 min), and 10 and 30 min post-drink consumption
Change form baseline Subjective Appetite
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline aggression
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline anger
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline excitement
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline disappointment
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline happiness
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline upset
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change form baseline frustration
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline alertness
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline sadness
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline tension
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline exhaustion
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline sleepiness
Time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink 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 10 Aug 2018.
- Derived from this study: PubMed 32814852Kucab M, Bellissimo N, Prusky C, Brett NR, Totosy de Zepetnek JO. Effects of a high-intensity interval training session and chocolate milk on appetite and cognitive performance in youth aged 9-13 years. Eur J Clin Nutr. 2021 Jan;75(1):172-179. doi: 10.1038/s41430-020-00718-z. Epub 2020 Aug 19.
- Individual participant dataSharing planned: No
Related trials for Glycemic Response
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Active, not recruiting
Postprandial Glycemic and GLP-1 Responses to Modified Full-sugar Drinks
Postprandial Glucose, GLP-1 Concentration
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
Not yet recruiting
A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting
Postprandial Glucose, GI Tolerance
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 study director
School of Nutrition, Ryerson 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 Exercise and Chocolate Milk, Exercise and Water and Sitting and Chocolate Milk in people with Glycemic Response and Cognitive Function, 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 4 inclusion and 4 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 10 Aug 2018. 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?
Change from baseline Glycemic Response (time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption). 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 NCT03305107, 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 10 Aug 2018.