Glycemic ControlNCT02197195
Sugars-sweetened Beverages and Exercise on Glycaemic Response and Subjective Appetite in Children
A study testing Chocolate Milk, Fruit Drink and Exercise in people with Glycemic Control and Subjective Appetite, run by Toronto Metropolitan University at 1 site in Canada.
Trial summary
The purpose of the study is to understand the role chocolate milk compared to a fruit drink, with and without exercise, on glycaemic regulation and subjective appetite in children. Read more about this study
- Who is it for?
- Ages 9 to 14 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glycemic Control, Subjective Appetite
- What is being tested?
- Chocolate Milk, Fruit Drink and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Apr 2014
- 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
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, boy, born at full term and normal birth weight
Who cannot join
- Girls, have significant learning, behavioral, or emotional difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Chocolate Milk and Fruit Drink on Subjective Appetite and Glycaemic Response With or Without Exercise in Normal Weight 9-14 Year Old Boys
The purpose of the study is to understand the role chocolate milk compared to a fruit drink, with and without exercise, on glycaemic regulation and subjective appetite in children. The investigators hypothesize that chocolate milk in combination with exercise will have the greatest effect attenuating glycaemic response. Blood glucose will be measured by finger prick following drink consumption (0 min) and exercise or sitting (15 min), and at 65 minutes. Subjective appetite will be measured at 0, 20, 35, 50 and 65 minutes.
- Conditions
- Glycemic Control, Subjective Appetite
- Being tested
- Chocolate Milk, Fruit Drink, Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chocolate MilkDietary supplement
Fruit DrinkDietary supplement
ExerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Chocolate Milk Beverage | Experimental | Chocolate milk beverage and sitting quietly Receives: Dietary Supplement: Chocolate Milk |
| Chocolate Milk Beverage and Exercise | Experimental | Chocolate milk beverage and exercising Receives: Dietary Supplement: Chocolate Milk; Behavioral: Exercise |
| Fruit Drink Beverage | Experimental | Fruit drink beverage and sitting quietly Receives: Dietary Supplement: Fruit Drink |
| Fruit Drink Beverage and Exercise | Experimental | Fruit drink beverage and exercising Receives: Dietary Supplement: Fruit Drink; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose (mmol/L)
Blood Glucose (mmol/L) determined by fingerprick glucometer reading
Measured: at baseline (0), 20 and 65 minutes
Secondary outcomes (1)
Subjective Appetite (mm)
Subjective appetite (in mm) determined by visual analogue scale will be determined at 0, 20, 35, 50 and 65 minutes.
Measured: 0 - 65 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ControlStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197195
- Sponsor's protocol ID
- REB 2013-251
- Status last verified
- Jul 2014
- First submitted
- 20 Jul 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Chocolate Milk and Fruit Drink on Subjective Appetite and Glycaemic Response With or Without Exercise in Normal Weight 9-14 Year Old Boys
- ClinicalTrials.gov ID
- NCT02197195
- Acronym / sponsor ID
- REB 2013-251
- Conditions
- Glycemic Control, Subjective Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Jul 2014 (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 the study is to understand the role chocolate milk compared to a fruit drink, with and without exercise, on glycaemic regulation and subjective appetite in children. The investigators hypothesize that chocolate milk in combination with exercise will have the greatest effect attenuating glycaemic response. Blood glucose will be measured by finger prick following drink consumption (0 min) and exercise or sitting (15 min), and at 65 minutes. Subjective appetite will be measured at 0, 20, 35, 50 and 65 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chocolate Milk Beverage | Experimental | Dietary Supplement: Chocolate MilkChocolate milk beverage and sitting quietly |
| Chocolate Milk Beverage and Exercise | Experimental | Dietary Supplement: Chocolate Milk, Behavioral: ExerciseChocolate milk beverage and exercising |
| Fruit Drink Beverage | Experimental | Dietary Supplement: Fruit DrinkFruit drink beverage and sitting quietly |
| Fruit Drink Beverage and Exercise | Experimental | Dietary Supplement: Fruit Drink, Behavioral: ExerciseFruit drink beverage and exercising |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy, boy, born at full term and normal birth weight
Key exclusion criteria (1 listed)
- Girls, have significant learning, behavioral, or emotional difficulties
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 |
|---|---|---|
| Chocolate Milk | Dietary supplement | Chocolate Milk Beverage, Chocolate Milk Beverage and Exercise |
| Fruit Drink | Dietary supplement | Fruit Drink Beverage, Fruit Drink Beverage and Exercise |
| Exercise | Behavioural | Chocolate Milk Beverage and Exercise, Fruit Drink Beverage and Exercise |
Primary outcome
Blood Glucose (mmol/L)
Time frame: at baseline (0), 20 and 65 minutes
Blood Glucose (mmol/L) determined by fingerprick glucometer reading
1 secondary outcome
Subjective Appetite (mm)
Time frame: 0 - 65 mins
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 22 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chocolate Milk, Fruit Drink and Exercise in people with Glycemic Control and Subjective Appetite, 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 1 inclusion and 1 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 22 Jul 2014. 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?
Blood Glucose (mmol/L) (time frame: at baseline (0), 20 and 65 minutes). 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 22 Jul 2014.