FoodNCT02484625
The Effect of Dairy and Non-Dairy Snacks on Food Intake, Subjective Appetite in Children
A study testing Potato chips, Greek yogurt and Cookies in people with Food and Eating, run by Mount Saint Vincent University at 1 site in Canada.
Trial summary
Dairy products have the potential to be healthy snack foods for children and are provided in a variety of food matrices. For instance, milk represents a fluid product, yogurt can be classified as a semi-solid food, and finally, cheese is the example of solid food. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- What is being tested?
- Potato chips, Greek yogurt and Cookies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Aug 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
- Born at full-term within the normal weight range
- 9-14 year old
Who cannot join
- Food sensitivities or allergies,
- Dietary restrictions,
- Health, learning, emotional or behavioural problems
- Receiving medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Solid, Semi-Solid and Fluid Dairy Products on Short-Term Food Intake and Satiety in Children
Dairy products have the potential to be healthy snack foods for children and are provided in a variety of food matrices. For instance, milk represents a fluid product, yogurt can be classified as a semi-solid food, and finally, cheese is the example of solid food. This experiment is aimed to examine the effect of dairy products with different food matrices on satiety and food intake in children. Dairy products will be compared with other non-dairy snacks popular among children including cookies and potato chips.
- Being tested
- Potato chips, Greek yogurt, Cookies, Cheese, Milk
- Keywords
- Snacking, Food Intake, Satiety, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potato chipsOther
Commercially available potato chips, 180 kcal
Greek yogurtOther
Commercially available Greek yogurt, 180 kcal
CookiesOther
Commercially available cookies, 180 kcal
CheeseOther
Commercially available cheese, 180 kcal
MilkOther
Commercially available milk, 180 kcal
| Study group | Role | What they receive |
|---|---|---|
| Potato chips | Experimental | Commercial potato chips, 180 kcal Receives: Other: Potato chips |
| Greek yogurt | Experimental | Greek yogurt, 180 kcal Receives: Other: Greek yogurt |
| Cookies | Experimental | Sandwich-type cookies, 180 kcal Receives: Other: Cookies |
| Cheese | Experimental | Mozzarella cheese, 180 kcal Receives: Other: Cheese |
| Milk (fluid) | Experimental | Milk, 2% m.f., 180 kcal Receives: Other: Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake (grams and kcal) measured with a test meal
The amount of energy (kcal) consumed ad libitum with the test meal (pizza lunch) two hours later.
Measured: 120 min
Subjective appetite measured with Visual Analogue Scales
The subjective assessment of appetite parameters including a desire to eat, fullness, hunger and a prospective food consumption measured with 100 mm Visual Analogue Scales with two opposite statements at each end (e.g., for the hunger scale, 0 mm means not hungry at all, and 100 mm means very hungry).
Measured: 0-120 min
Secondary outcomes (1)
Cortisol
The concentration of salivary cortisol
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 2017
- Study completionAug 2017
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 FoodStudies 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
- Model description
- Randomized crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Saint Vincent University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
- Investigators
- Bohdan L Luhovyy, PhD, Principal investigator, Mount Saint Vincent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484625
- Sponsor's protocol ID
- 2011-001
- Other IDs
- 2016-130
- Status last verified
- Sep 2020
- First submitted
- 17 Apr 2015
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gheller BJF, Li AC, Gheller ME, Armstrong T, Vandenboer E, Bellissimo N, Anini Y, Hamilton J, Nunes F, Mollard RC, Anderson GH, Luhovyy BL. The effect of dairy products and non-dairy snacks on food intake, subjective appetite and cortisol levels in children: a randomized control study. Appl Physiol Nutr Metab. 2021 Sep;46(9):1097-1104. doi: 10.1139/apnm-2020-0909. Epub 2021 Mar 16.
PubMed 33725464
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Solid, Semi-Solid and Fluid Dairy Products on Short-Term Food Intake and Satiety in Children
- ClinicalTrials.gov ID
- NCT02484625
- Acronym / sponsor ID
- 2011-001
- Keywords
- Snacking, Food Intake, Satiety, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mount Saint Vincent UniversityUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Nov 2011 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (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 the potential to be healthy snack foods for children and are provided in a variety of food matrices. For instance, milk represents a fluid product, yogurt can be classified as a semi-solid food, and finally, cheese is the example of solid food. This experiment is aimed to examine the effect of dairy products with different food matrices on satiety and food intake in children. Dairy products will be compared with other non-dairy snacks popular among children including cookies and potato chips.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Randomized crossover
| Arm | Type | Receives |
|---|---|---|
| Potato chips | Experimental | Other: Potato chipsCommercial potato chips, 180 kcal |
| Greek yogurt | Experimental | Other: Greek yogurtGreek yogurt, 180 kcal |
| Cookies | Experimental | Other: CookiesSandwich-type cookies, 180 kcal |
| Cheese | Experimental | Other: CheeseMozzarella cheese, 180 kcal |
| Milk (fluid) | Experimental | Other: MilkMilk, 2% m.f., 180 kcal |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Born at full-term within the normal weight range
- 9-14 year old
Key exclusion criteria (4 listed)
- Food sensitivities or allergies,
- Dietary restrictions,
- Health, learning, emotional or behavioural problems
- 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 |
|---|---|---|
| Potato chipsCommercially available potato chips, 180 kcal | Other | Potato chips |
| Greek yogurtCommercially available Greek yogurt, 180 kcal | Other | Greek yogurt |
| CookiesCommercially available cookies, 180 kcal | Other | Cookies |
| CheeseCommercially available cheese, 180 kcal | Other | Cheese |
| MilkCommercially available milk, 180 kcal | Other | Milk (fluid) |
Primary outcome
Food intake (grams and kcal) measured with a test meal
Time frame: 120 min
The amount of energy (kcal) consumed ad libitum with the test meal (pizza lunch) two hours later.
Subjective appetite measured with Visual Analogue Scales
Time frame: 0-120 min
The subjective assessment of appetite parameters including a desire to eat, fullness, hunger and a prospective food consumption measured with 100 mm Visual Analogue Scales with two opposite statements at each end (e.g., for the hunger scale, 0 mm means not hungry at all, and 100 mm means very hungry).
1 secondary outcome
Cortisol
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 18 Sep 2020.
- Derived from this study: PubMed 33725464Gheller BJF, Li AC, Gheller ME, Armstrong T, Vandenboer E, Bellissimo N, Anini Y, Hamilton J, Nunes F, Mollard RC, Anderson GH, Luhovyy BL. The effect of dairy products and non-dairy snacks on food intake, subjective appetite and cortisol levels in children: a randomized control study. Appl Physiol Nutr Metab. 2021 Sep;46(9):1097-1104. doi: 10.1139/apnm-2020-0909. Epub 2021 Mar 16.
Related trials for Food
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Effects of Ad Libitum Ultra-Processed Diet on Brain Dopamine in Humans
Healthy Volunteers
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Not yet recruitingObservational study
Discovering Determinants of Food Intake by Application of Artificial Intelligence to Complex, High-Dimensional Data
Healthy Volunteer
Not yet recruitingPhase 1
A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of UBT48128 Tablets in Healthy Participants
Overweight , 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.
Bohdan L Luhovyy, PhD principal investigator
Mount Saint Vincent 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 Potato chips, Greek yogurt and Cookies in people with Food and Eating, 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 2 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 18 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?
Food intake (grams and kcal) measured with a test meal (time frame: 120 min). The study lists 2 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 NCT02484625, 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 18 Sep 2020.