Blood GlucoseNCT03914430
Breakfast Cereals Consumed in Dairy and Non-dairy Medium: the Effects on Blood Glucose, Satiety and Food Intake
A study testing Food in people with Blood Glucose and Eating, run by Mount Saint Vincent University at 1 site in Canada.
Trial summary
The effects of dairy-free products consumed with a breakfast meal on food intake and glycaemic regulation remain unexplored. It is known that dairy products are an excellent source of protein, low glycaemic sugar lactose, calcium, and vitamin D. Read more about this study
- Who is it for?
- Ages 19 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, Eating, Food
- What is being tested?
- Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 20 Nov 2015to 17 Nov 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 19 to 28 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy females
Who cannot join
- Overweight or obese
- Breakfast skippers
- Have any chronic metabolic diseases
- Smokers
- Taking medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dairy and Non-Dairy Cultured Products Added to Breakfast Cereals on Satiation, Satiety, Blood Glucose Control and Short-Term Food Intake in Young Adults
The effects of dairy-free products consumed with a breakfast meal on food intake and glycaemic regulation remain unexplored. It is known that dairy products are an excellent source of protein, low glycaemic sugar lactose, calcium, and vitamin D. In our recent study the consumption of a dairy snack with high protein content resulted in reduced blood glucose response compared to non-dairy snack with the similar amount of available carbohydrate. The investigators hypothesize that the ad libitum intake of breakfast cereals served with a high-protein fermented dairy product will result in reduced and sustained blood glucose response compared to non-dairy control. The objective of this study is to investigate how dairy and non-dairy cultured products used as carriers for breakfast granola cereals and consumed ad libitum affect short-term food intake, satiety, and glycaemia within two hours.
- Conditions
- Blood Glucose, Eating, Food
- Being tested
- Food
- Keywords
- Breakfast, Blood glucose, Food intake, Satiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoodOther
The intervention represents a breakfast meal (cereals with cultured products) or breakfast skipping (water control)
| Study group | Role | What they receive |
|---|---|---|
| Breakfast meal with granola cereal and cultured dairy | Experimental | Not described Receives: Other: Food |
| Breakfast meal with granola cereal and cultured non-dairy | Experimental | Not described Receives: Other: Food |
| Water | Experimental | Energy-free control Receives: Other: Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial blood glucose concentration
The concentration of blood glucose in venous blood after the ad libitum breakfast meal or water control.
Measured: 0-120 minutes
Subjective feeling of appetite
The subjective assessment of appetite parameters including desire to eat, fullness, hunger and a prospectiove 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 minutes
Ad libitum food intake
The amount of energy (kcal) consumed ad libitum with the breakfast meal or water control and with the test meal (pizza lunch) two hour later.
Measured: 0-120 minutes
Secondary outcomes (3)
Circulatory insulin concentration
The concentration of insulin in blood
Measured: 0-120 minutes
Subjective feeling of physical comfort
The subjective assessment of wellness and gastrointestinal symptoms including feeling of nausea, diarrhoea, flatulence and other parameters measured with 100 mm Visual Analogue Scales with two opposite statements at each end.
Measured: 0-120 minutes
Subjective feeling of food palatability (pleasantness)
The pleasantness of the breakfast meal and pizza meal measured with 100 mm Visual Analogue Scales with two opposite statements at each end.(e.g., 0 mm means that food is not pleasant at all, and 100 mm means that the food is very pleasant).
Measured: 0, 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start20 Nov 2015
- Primary completion30 Jul 2016
- Study completion17 Nov 2017
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Saint Vincent University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Dairy Farmers of Canada
- Responsible party
- Principal investigator, Bohdan Luhovyy, Mount Saint Vincent University
- Investigators
- Bohdan Luhovyy, PhD, Principal investigator, Mount Saint Vincent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914430
- Sponsor's protocol ID
- 2015-013
- Status last verified
- Apr 2019
- First submitted
- 2 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dairy and Non-Dairy Cultured Products Added to Breakfast Cereals on Satiation, Satiety, Blood Glucose Control and Short-Term Food Intake in Young Adults
- ClinicalTrials.gov ID
- NCT03914430
- Acronym / sponsor ID
- 2015-013
- Conditions
- Blood Glucose, Eating, Food
- Keywords
- Breakfast, Blood glucose, Food intake, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mount Saint Vincent UniversityUniversity, hospital or other
- Collaborators
- University of Toronto, Dairy Farmers of Canada
- Study start
- 20 Nov 2015 (actual)
- Primary completion
- 30 Jul 2016 (actual)
- Study completion
- 17 Nov 2017 (actual)
- First posted
- 16 Apr 2019 (actual)
- 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 effects of dairy-free products consumed with a breakfast meal on food intake and glycaemic regulation remain unexplored. It is known that dairy products are an excellent source of protein, low glycaemic sugar lactose, calcium, and vitamin D. In our recent study the consumption of a dairy snack with high protein content resulted in reduced blood glucose response compared to non-dairy snack with the similar amount of available carbohydrate. The investigators hypothesize that the ad libitum intake of breakfast cereals served with a high-protein fermented dairy product will result in reduced and sustained blood glucose response compared to non-dairy control. The objective of this study is to investigate how dairy and non-dairy cultured products used as carriers for breakfast granola cereals and consumed ad libitum affect short-term food intake, satiety, and glycaemia within two hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breakfast meal with granola cereal and cultured dairy | Experimental | Other: Food |
| Breakfast meal with granola cereal and cultured non-dairy | Experimental | Other: Food |
| Water | Experimental | Other: FoodEnergy-free control |
Who may qualify
- Ages
- 19 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy females
Key exclusion criteria (5 listed)
- Overweight or obese
- Breakfast skippers
- Have any chronic metabolic diseases
- Smokers
- Taking 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 |
|---|---|---|
| FoodThe intervention represents a breakfast meal (cereals with cultured products) or breakfast skipping (water control) | Other | Breakfast meal with granola cereal and cultured dairy, Breakfast meal with granola cereal and cultured non-dairy, Water |
Primary outcome
Postprandial blood glucose concentration
Time frame: 0-120 minutes
The concentration of blood glucose in venous blood after the ad libitum breakfast meal or water control.
Subjective feeling of appetite
Time frame: 0-120 minutes
The subjective assessment of appetite parameters including desire to eat, fullness, hunger and a prospectiove 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).
Ad libitum food intake
Time frame: 0-120 minutes
The amount of energy (kcal) consumed ad libitum with the breakfast meal or water control and with the test meal (pizza lunch) two hour later.
3 secondary outcomes
Circulatory insulin concentration
Time frame: 0-120 minutes
Subjective feeling of physical comfort
Time frame: 0-120 minutes
Subjective feeling of food palatability (pleasantness)
Time frame: 0, 120 minutes
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 16 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Bohdan 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 Food in people with Blood Glucose 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 1 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 16 Apr 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?
Postprandial blood glucose concentration (time frame: 0-120 minutes). 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 16 Apr 2019.