Blood Glucose, HighNCT05400694
Functional and Value-Added Dairy Products and Blood Glucose Control
A study testing Food in people with Blood Glucose, High and Metabolic Disease, run by Mount Saint Vincent University at 1 site in Canada.
Trial summary
Milk proteins possess multiple biological activities including their effect on blood glucose control, satiety and energy intake. The design of functional food products with added milk protein fractions has many challenges related to their inferior sensory properties. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, High, Metabolic Disease, Overweight and Obesity
- What is being tested?
- Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2021to 31 Mar 2023
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19-35 y males and females, non-smokers
Who cannot join
- having any diseases, irregular menses in females, smoking (all types), taking medications known to influence blood glucose control, skipping breakfast, and having emotional, or learning problems that would affect their ability to participate in the study as required. Individuals with known food allergies and lactose intolerance will be also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Sensory and Metabolic Effects of Functional and Value-Added Dairy Products
Milk proteins possess multiple biological activities including their effect on blood glucose control, satiety and energy intake. The design of functional food products with added milk protein fractions has many challenges related to their inferior sensory properties. Chocolate milk presents the universal vehicle for added milk protein fractions that might partially mask their sensory characteristics. However, commercially produced chocolate milk has a significant amount of added sugar. This project will investigate the properties of a value-added dairy product (chocolate milk with reduced sugar content) enriched with individual milk protein fractions on characteristics of blood glucose control, satiety and energy intake in young healthy adults.
- Being tested
- Food
- Keywords
- Sugar intake, Sweeteners, Milk Proteins, Diabetes, Obesity, Sweetened food products, Chocolate milk, Blood glucose, Insulin, Satiety, Food Intake, Casein, Whey protein
- Medical subject headings
- Metabolic Diseases, Overweight, Obesity, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoodOther
Dairy products with reduced sugar content
| Study group | Role | What they receive |
|---|---|---|
| Chocolate milk | Experimental | Chocolate milk with reduced added sugar Receives: Other: Food |
| Chocolate milk with whey protein | Experimental | Chocolate milk with reduced added sugar and added whey protein Receives: Other: Food |
| Chocolate milk with casein | Experimental | Chocolate milk with reduced added sugar and added casein Receives: Other: Food |
| Chocolate milk with alpha-lactalbumin | Experimental | Chocolate milk with reduced added sugar and added alpha-lactalbumin Receives: Other: Food |
| Chocolate milk with glycomacropeptide | Experimental | Chocolate milk with reduced added sugar and added glycomacropeptide Receives: Other: Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
The concentration of blood glucose
Measured: 0-120 minutes
Insulin
The concentration of insulin
Measured: 0-120 minutes
Secondary outcomes (7)
C-peptide
The concentration of C-peptide
Measured: 0-120 minutes
Incretins, glucagon and amino acids
The concentration of incretins and glucagon
Measured: 0-120 minutes
Satiety
The components of average subjective appetite including desire to eat, hunger, fullness, and a prospective food consumption measured with 100mm visual analogue scales.
Measured: 0-120 minutes
Food Intake
Energy intake with an ad libitum meat at 120 minutes
Measured: 0 min, 120 minutes
Thirst
The subjective perception of thirst measured with 100mm visual analogue scales containing the question "How thirsty do you feel?" and two statements on each pole of 100mm line: "Not thirsty at all" (0mm) and "As thirsty as I have ever felt" (100mm).
Measured: 0-120 minutes
Physical comfort
The subjective feeling of wellness and gastrointestinal discomfort parameters including the feeling of nausea, stomach cramps, flatulency, diarrhea and a subjective feeling of wellness, each measured with 100mm visual analogue scales.
Measured: 0-120 minutes
Food pleasantness
The perception of pleasantness of the treatments (0 minutes) and a test meal (at 120 minutes) will be measured with 100mm visual analogue scale.
Measured: at 0 and 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Oct 2021
- Primary completion31 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose, HighStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Saint Vincent University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- 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
- NCT05400694
- Sponsor's protocol ID
- 2019-202-02
- Status last verified
- Oct 2023
- First submitted
- 26 May 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sensory and Metabolic Effects of Functional and Value-Added Dairy Products
- ClinicalTrials.gov ID
- NCT05400694
- Acronym / sponsor ID
- 2019-202-02
- Keywords
- Sugar intake, Sweeteners, Milk Proteins, Diabetes, Obesity, Sweetened food products, Chocolate milk, Blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mount Saint Vincent UniversityUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 1 Jun 2022 (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.
Milk proteins possess multiple biological activities including their effect on blood glucose control, satiety and energy intake. The design of functional food products with added milk protein fractions has many challenges related to their inferior sensory properties. Chocolate milk presents the universal vehicle for added milk protein fractions that might partially mask their sensory characteristics. However, commercially produced chocolate milk has a significant amount of added sugar. This project will investigate the properties of a value-added dairy product (chocolate milk with reduced sugar content) enriched with individual milk protein fractions on characteristics of blood glucose control, satiety and energy intake in young healthy adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Chocolate milk | Experimental | Other: FoodChocolate milk with reduced added sugar |
| Chocolate milk with whey protein | Experimental | Other: FoodChocolate milk with reduced added sugar and added whey protein |
| Chocolate milk with casein | Experimental | Other: FoodChocolate milk with reduced added sugar and added casein |
| Chocolate milk with alpha-lactalbumin | Experimental | Other: FoodChocolate milk with reduced added sugar and added alpha-lactalbumin |
| Chocolate milk with glycomacropeptide | Experimental | Other: FoodChocolate milk with reduced added sugar and added glycomacropeptide |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 19-35 y males and females, non-smokers
Key exclusion criteria (1 listed)
- having any diseases, irregular menses in females, smoking (all types), taking medications known to influence blood glucose control, skipping breakfast, and having emotional, or learning problems that would affect their ability to participate in the study as required. Individuals with known food allergies and lactose intolerance will be also excluded.
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 |
|---|---|---|
| FoodDairy products with reduced sugar content | Other | Chocolate milk, Chocolate milk with alpha-lactalbumin, Chocolate milk with casein, Chocolate milk with glycomacropeptide, Chocolate milk with whey protein |
Primary outcome
Blood glucose
Time frame: 0-120 minutes
The concentration of blood glucose
Insulin
Time frame: 0-120 minutes
The concentration of insulin
7 secondary outcomes
C-peptide
Time frame: 0-120 minutes
Incretins, glucagon and amino acids
Time frame: 0-120 minutes
Satiety
Time frame: 0-120 minutes
Food Intake
Time frame: 0 min, 120 minutes
Thirst
Time frame: 0-120 minutes
Physical comfort
Time frame: 0-120 minutes
Food pleasantness
Time frame: at 0 and 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 19 Oct 2023.
- 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, High and Metabolic Disease, 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 19 Oct 2023. 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: 0-120 minutes). 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?
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 19 Oct 2023.