OverweightNCT02200796
Role of Dietary Protein on Satiety, Food Intake and Thermic Effect of Food
A study testing Low Protein Meal, Moderate Protein Meal and High Protein Meal in people with Overweight and Obesity, run by Toronto Metropolitan University at 1 site in Canada.
Trial summary
Objectives: To determine the effect of protein content of familiar breakfast meals on subjective appetite, food intake (FI), glycemic response and Thermic Effect of Food (TEF) in normal weight (NW) and overweight (OW)/obese (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
- Overweight, Obesity
- What is being tested?
- Low Protein Meal, Moderate Protein Meal and High Protein Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Dec 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
- Boys and girls between the ages of 9 and 14 y
- Only peri-pubertal girls
- 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
- Food allergies
- Dietary restrictions
- Health, learning, emotional or behavioural problems
- On any medication
Trial locations and contacts
1 site in 1 country.
Canada1 site
Ryerson University, FIRST Labaratory. 350 Victoria Street
Toronto, Ontario, M5B 2K3
About this study
Official title: Role of Dietary Protein in a Familiar Breakfast Meal on Subjective Satiety, Food Intake and Thermic Effect of Food in Normal Weight and Overweight/Obese Children
Objectives: To determine the effect of protein content of familiar breakfast meals on subjective appetite, food intake (FI), glycemic response and Thermic Effect of Food (TEF) in normal weight (NW) and overweight (OW)/obese (OB) children.
Specific Objectives:
Read more
1a.To determine the effect of familiar breakfast meals (450 kcal containing eggs and varying in protein content (15, 30, and 45g) on subjective appetite, glycemic response and food intake at a test meal 4 h later in NW and. OW/OB children.
1b. To describe the effect of isocaloric (450 kcal) familiar breakfasts either high in protein (optimal protein from Objective 1a) or low in protein on TEF and substrate utilization over 5 h in NW and OW/OB children.
Read the detailed description
Hypothesis: The investigators hypothesize that increasing the high-quality protein content of a breakfast meal will dose dependently increase subjective satiety, lower FI and glycemic response, and increase the TEF in both NW and OW/OB children.
- Conditions
- Overweight, Obesity
- Being tested
- Control Meal, Low Protein Meal, Moderate Protein Meal, High Protein Meal
- Keywords
- Dietary Protein, Satiety, Food Intake, Thermic Effect of Food, Diet Induced Thermogenesis
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control MealOther
High carbohydrate meal
Low Protein MealOther
Omelet with 15 g of protein
Moderate Protein MealOther
Omelet with 30 g of protein
High Protein MealOther
Omelet with 45 g of protein
| Study group | Role | What they receive |
|---|---|---|
| Low Protein Meal | Experimental | Low Protein Test Meal (15 g) Receives: Other: Low Protein Meal |
| Moderate Protein Meal | Experimental | Moderate Protein Meal (30 g) Receives: Other: Moderate Protein Meal |
| High Protein Meal | Experimental | High Protein Meal (45g) Receives: Other: High Protein Meal |
| Control Meal | Experimental | High Carbohydrate Control Meal (7 g of protein) Receives: Other: Control Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
1a) Ad libitum food intake (in kcal)
Measured: Four hours after breakfast
Secondary outcomes (3)
1b) The thermic effect of a high versus low protein meal
REE will be determined by indirect calorimetry under a ventilated hood (ParvoMedics TrueOne 2400 automated metabolic gas analysis system, Parvo Medics, USA)
Measured: Resting energy expenditure (REE) at baseline and up to five hours post test meal
Subjective Appetite
Measured: Assessed every 15 min for 4 h
Blood glucose response
Finger prick capillary blood glucose (in mmol/L) at baseline, after breakfast (30 min), at 60 min, and in 1h intervals onward
Measured: Measures at 15, or 60 min intervals for 4 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- 17 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
- NCT02200796
- Sponsor's protocol ID
- tempID
- Status last verified
- Sep 2020
- First submitted
- 20 Jul 2014
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dietary Protein in a Familiar Breakfast Meal on Subjective Satiety, Food Intake and Thermic Effect of Food in Normal Weight and Overweight/Obese Children
- ClinicalTrials.gov ID
- NCT02200796
- Acronym / sponsor ID
- tempID
- Conditions
- Overweight, Obesity
- Keywords
- Dietary Protein, Satiety, Food Intake, Thermic Effect of Food, Diet Induced Thermogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 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.
Objectives: To determine the effect of protein content of familiar breakfast meals on subjective appetite, food intake (FI), glycemic response and Thermic Effect of Food (TEF) in normal weight (NW) and overweight (OW)/obese (OB) children.
Specific Objectives:
1a.To determine the effect of familiar breakfast meals (450 kcal containing eggs and varying in protein content (15, 30, and 45g) on subjective appetite, glycemic response and food intake at a test meal 4 h later in NW and. OW/OB children.
1b. To describe the effect of isocaloric (450 kcal) familiar breakfasts either high in protein (optimal protein from Objective 1a) or low in protein on TEF and substrate utilization over 5 h in NW and OW/OB children.
Detailed description
Hypothesis: The investigators hypothesize that increasing the high-quality protein content of a breakfast meal will dose dependently increase subjective satiety, lower FI and glycemic response, and increase the TEF in both NW and OW/OB children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Protein Meal | Experimental | Other: Low Protein MealLow Protein Test Meal (15 g) |
| Moderate Protein Meal | Experimental | Other: Moderate Protein MealModerate Protein Meal (30 g) |
| High Protein Meal | Experimental | Other: High Protein MealHigh Protein Meal (45g) |
| Control Meal | Experimental | Other: Control MealHigh Carbohydrate Control Meal (7 g of protein) |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Boys and girls between the ages of 9 and 14 y
- Only peri-pubertal girls
- Normal body weight (between the 5th and 85th BMI percentile for age and gender)
- OW/OB (>85th BMI percentile for age and gender)
Key exclusion criteria (5 listed)
- Food sensitivities
- Food allergies
- Dietary restrictions
- Health, learning, emotional or behavioural problems
- On any 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 |
|---|---|---|
| Control MealHigh carbohydrate meal | Other | Control Meal |
| Low Protein MealOmelet with 15 g of protein | Other | Low Protein Meal |
| Moderate Protein MealOmelet with 30 g of protein | Other | Moderate Protein Meal |
| High Protein MealOmelet with 45 g of protein | Other | High Protein Meal |
Primary outcome
1a) Ad libitum food intake (in kcal)
Time frame: Four hours after breakfast
3 secondary outcomes
1b) The thermic effect of a high versus low protein meal
Time frame: Resting energy expenditure (REE) at baseline and up to five hours post test meal
Subjective Appetite
Time frame: Assessed every 15 min for 4 h
Blood glucose response
Time frame: Measures at 15, or 60 min intervals for 4 h
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 30 Sep 2020.
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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 Low Protein Meal, Moderate Protein Meal and High Protein Meal in people with Overweight and Obesity, 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 5 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 30 Sep 2020. 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?
1a) Ad libitum food intake (in kcal) (time frame: Four 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 30 Sep 2020.