Childhood ObesityNCT03045354
Dietary Carbohydrate Consumption at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite
A study testing Mashed potatoes, Traditional breakfast and Breakfast skipping in people with Childhood Obesity and Breakfast, run by Toronto Metropolitan University at 1 site in Canada.
Trial summary
The purpose of this study is to determine the effect of carbohydrates of familiar breakfast meals on glycemic response, subjective appetite, and food intake in 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
- Childhood Obesity, Breakfast
- What is being tested?
- Mashed potatoes, Traditional breakfast and Breakfast skipping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Sep 2017
- 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
- not be taking any medications
- not have allergies or sensitivities to potatoes, eggs, gluten, dairy, or beans
- NW (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 behavioural problems
- receiving any medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Carbohydrate-Containing Foods at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite in Normal Weight and Overweight/Obese Children
The purpose of this study is to determine the effect of carbohydrates of familiar breakfast meals on glycemic response, subjective appetite, and food intake in normal weight (NW) and overweight or obese (OW/OB) children.
Read the detailed description
Regular breakfast eating NW and OW/OB children, 9-14 years of age, will participate in the experiment. Four isocaloric (450 kcal) breakfasts (eggs with a side of French fries, mashed potatoes, or beans, and control breakfast of milk, cereal and toast) and breakfast skipping will be examined. On five separate mornings, 7 days apart and after a 12 hour overnight fast, each participant will receive one of the four breakfasts or skip breakfast, in a randomized counterbalanced order. Participants will be given an ad libitum lunch 3 hours after breakfast and parents will report the rest of day food record for food intake analysis. Blood glucose will be measured via finger-prick at baseline, and 30, 60, 120, and 180 minutes after breakfast consumption. Subjective appetite will be measured with a visual analogue scale at baseline and every 15 minutes for 1 hour, and every hour for 3 hours.
- Conditions
- Childhood Obesity, Breakfast
- Being tested
- Mashed potatoes, Traditional breakfast, Breakfast skipping, French fries, Beans
- Keywords
- children, dietary carbohydrates, satiety, appetite, blood glucose, solanum tuberosum, obesity, breakfast
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mashed potatoesOther
Isocaloric (450 kcal) breakfast treatments of eggs with a side of mashed potatoes
Traditional breakfastOther
Isocaloric (450 kcal) control breakfast treatments of cereal, milk, toast and jam
Breakfast skippingOther
No breakfast
French friesOther
Isocaloric (450 kcal) breakfast treatments of eggs with a side of French fries
BeansOther
Isocaloric (450 kcal) breakfast treatments of eggs with a side of beans
| Study group | Role | What they receive |
|---|---|---|
| Mashed potatoes | Experimental | Eggs with a side of mashed potatoes Receives: Other: Mashed potatoes |
| French fries | Experimental | Eggs with a side of French fries Receives: Other: French fries |
| Beans | Experimental | Eggs with a side of beans Receives: Other: Beans |
| Traditional breakfast | Experimental | Cereal, milk, toast and jam Receives: Other: Traditional breakfast |
| Breakfast skipping | Experimental | No breakfast Receives: Other: Breakfast skipping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term food intake (kcal)
Participants will consume an ad libitum lunch 3 hours post breakfast consumption.
Measured: 3 hours after breakfast
Secondary outcomes (3)
Subjective appetite
Participants will complete subjective ratings on appetite and well-being
Measured: Baseline, at 15 or 60 minutes intervals for 3 hours
Blood glucose
Finger prick capillary blood glucose will be collected
Measured: Baseline, 30, 60, 120 and 180 minutes after breakfast
Rest of day food record
Parents/guardians will record participants' food intake until the end of the day
Measured: 8-12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study startOct 2016
- Primary completionJun 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies 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
- NCT03045354
- Sponsor's protocol ID
- REB2016-227
- Status last verified
- Jul 2018
- First submitted
- 3 Feb 2017
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Carbohydrate-Containing Foods at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite in Normal Weight and Overweight/Obese Children
- ClinicalTrials.gov ID
- NCT03045354
- Acronym / sponsor ID
- REB2016-227
- Conditions
- Childhood Obesity, Breakfast
- Keywords
- children, dietary carbohydrates, satiety, appetite, blood glucose, solanum tuberosum, obesity, breakfast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 7 Feb 2017 (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 of familiar breakfast meals on glycemic response, subjective appetite, and food intake in normal weight (NW) and overweight or obese (OW/OB) children.
Detailed description
Regular breakfast eating NW and OW/OB children, 9-14 years of age, will participate in the experiment. Four isocaloric (450 kcal) breakfasts (eggs with a side of French fries, mashed potatoes, or beans, and control breakfast of milk, cereal and toast) and breakfast skipping will be examined. On five separate mornings, 7 days apart and after a 12 hour overnight fast, each participant will receive one of the four breakfasts or skip breakfast, in a randomized counterbalanced order. Participants will be given an ad libitum lunch 3 hours after breakfast and parents will report the rest of day food record for food intake analysis. Blood glucose will be measured via finger-prick at baseline, and 30, 60, 120, and 180 minutes after breakfast consumption. Subjective appetite will be measured with a visual analogue scale at baseline and every 15 minutes for 1 hour, and every hour for 3 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Mashed potatoes | Experimental | Other: Mashed potatoesEggs with a side of mashed potatoes |
| French fries | Experimental | Other: French friesEggs with a side of French fries |
| Beans | Experimental | Other: BeansEggs with a side of beans |
| Traditional breakfast | Experimental | Other: Traditional breakfastCereal, milk, toast and jam |
| Breakfast skipping | Experimental | Other: Breakfast skippingNo breakfast |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- be between 9 and 14 years of age
- be healthy, and have been born at term
- not be taking any medications
- not have allergies or sensitivities to potatoes, eggs, gluten, dairy, or beans
- NW (between the 5th and 85th BMI percentile for age and gender)
Key exclusion criteria (3 listed)
- food sensitivities, allergies, or dietary restrictions
- health, learning, emotional, or behavioural 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 |
|---|---|---|
| Mashed potatoesIsocaloric (450 kcal) breakfast treatments of eggs with a side of mashed potatoes | Other | Mashed potatoes |
| Traditional breakfastIsocaloric (450 kcal) control breakfast treatments of cereal, milk, toast and jam | Other | Traditional breakfast |
| Breakfast skippingNo breakfast | Other | Breakfast skipping |
| French friesIsocaloric (450 kcal) breakfast treatments of eggs with a side of French fries | Other | French fries |
| BeansIsocaloric (450 kcal) breakfast treatments of eggs with a side of beans | Other | Beans |
Primary outcome
Short-term food intake (kcal)
Time frame: 3 hours after breakfast
Participants will consume an ad libitum lunch 3 hours post breakfast consumption.
3 secondary outcomes
Subjective appetite
Time frame: Baseline, at 15 or 60 minutes intervals for 3 hours
Blood glucose
Time frame: Baseline, 30, 60, 120 and 180 minutes after breakfast
Rest of day food record
Time frame: 8-12 hours
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 Jul 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
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 Mashed potatoes, Traditional breakfast and Breakfast skipping in people with Childhood Obesity and Breakfast, 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 6 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 23 Jul 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?
Short-term food intake (kcal) (time frame: 3 hours after breakfast). 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 Jul 2018.