Blood GlucoseNCT02484313
The Effect of Snacks on Glycaemic Regulation in Children
A study testing dietary treatments in people with Blood Glucose and Energy Intake, run by Mount Saint Vincent University at 1 site in Canada.
Trial summary
Dairy products have a potential to be healthy snack foods for children. The purpose of this project is to investigate the short-term effects of Greek yogurt, a new popular dairy product on the regulation of glucose homeostasis, satiety and energy intake in normal weight and overweight/obese children. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, Energy Intake
- What is being tested?
- dietary treatments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Aug 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
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The children must be born at full-term within the normal weight range
Who cannot join
- food sensitivities or allergies, dietary restrictions, health, learning, emotional or behavioural problems, of if children are receiving medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dairy and Non-Dairy Products on Blood Glucose Regulation in Children
Dairy products have a potential to be healthy snack foods for children. The purpose of this project is to investigate the short-term effects of Greek yogurt, a new popular dairy product on the regulation of glucose homeostasis, satiety and energy intake in normal weight and overweight/obese children.
- Conditions
- Blood Glucose, Energy Intake
- Being tested
- dietary treatments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary treatmentsOther
commercially available food products
| Study group | Role | What they receive |
|---|---|---|
| Greek yogurt | Experimental | 25 g available carbohydrates Receives: Other: dietary treatments |
| Cookies | Experimental | 25 g available carbohydrates Receives: Other: dietary treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose
concentration of blood glucose
Measured: 120 min
insulin
concentration of circulating insulin
Measured: 120 min
C-peptide
concentration of circulating C-peptide
Measured: 120 min
Secondary outcomes (2)
Food intake (grams and kcal)
ad libitum food intake at 120 min measured with a test meal (grams consumed converted to kilocalories).
Measured: 120 min
Subjective appetite
Four patterns of subjective appetite were measured using 100 mm visual analogue scale (VAS): desire to eat, hunger, fullness, and prospective food consumption at 0 min (immediately before the snack), 15, 30, 45, 60, 90, and immediately before the test meal at 120 min. The average appetite was calculated.
Measured: 0-120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startNov 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Saint Vincent University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, IWK Health Centre
- Responsible party
- Sponsor
- Investigators
- Harvey Anderson, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484313
- Sponsor's protocol ID
- 2011-001(2)
- Status last verified
- Jan 2019
- First submitted
- 17 Apr 2015
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dairy and Non-Dairy Products on Blood Glucose Regulation in Children
- ClinicalTrials.gov ID
- NCT02484313
- Acronym / sponsor ID
- 2011-001(2)
- Conditions
- Blood Glucose, Energy Intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mount Saint Vincent UniversityUniversity, hospital or other
- Collaborators
- University of Toronto, IWK Health Centre
- Study start
- Nov 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 29 Jun 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.
Dairy products have a potential to be healthy snack foods for children. The purpose of this project is to investigate the short-term effects of Greek yogurt, a new popular dairy product on the regulation of glucose homeostasis, satiety and energy intake in normal weight and overweight/obese children.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Greek yogurt | Experimental | Other: dietary treatments25 g available carbohydrates |
| Cookies | Experimental | Other: dietary treatments25 g available carbohydrates |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The children must be born at full-term within the normal weight range
Key exclusion criteria (1 listed)
- food sensitivities or allergies, dietary restrictions, health, learning, emotional or behavioural problems, of if children are receiving medication
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 |
|---|---|---|
| dietary treatmentscommercially available food products | Other | Cookies, Greek yogurt |
Primary outcome
blood glucose
Time frame: 120 min
concentration of blood glucose
insulin
Time frame: 120 min
concentration of circulating insulin
C-peptide
Time frame: 120 min
concentration of circulating C-peptide
2 secondary outcomes
Food intake (grams and kcal)
Time frame: 120 min
Subjective appetite
Time frame: 0-120 min
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 23 Jan 2019.
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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.
Harvey Anderson, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary treatments in people with Blood Glucose and Energy Intake, run by Mount Saint Vincent 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 23 Jan 2019. 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 (time frame: 120 min). The study lists 3 primary outcomes in all. 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 23 Jan 2019.