Blood Glucose, HighNCT04854603
Dairy Products With Reduced Sugar and Blood Glucose
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
Dairy products represent an important food group in human nutrition as a source of calcium, protein, functional fats and low-glycaemic sugar lactose. While traditionally consumed natural milk and yogurt have low sugar content, many flavoured liquid dairy products such as chocolate milk, or fermented products such as… 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
- 2 Sep 2021to 31 Aug 2022
- 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 Effect of Dairy Products With Reduced Added Sugar Content on Blood Glucose, Satiety and Food Intake
Dairy products represent an important food group in human nutrition as a source of calcium, protein, functional fats and low-glycaemic sugar lactose. While traditionally consumed natural milk and yogurt have low sugar content, many flavoured liquid dairy products such as chocolate milk, or fermented products such as yogurt have added sugar. Our recent studies have shown that the partial reduction of added sugar in chocolate milk and yogurt is not associated with any inferior sensory characteristics such as taste and pleasantness compared to their full-sugar counterparts. The current project will investigate whether the liquid dairy products with reduced sugar content (value-added products) have any benefits on blood glucose control in humans.
- Being tested
- Food
- Keywords
- Sugar intake, Sweeteners, Diabetes, Obesity, Sweetened food products, Chocolate milk
- Medical subject headings
- Metabolic Diseases, Overweight, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoodOther
Dairy products with regular and reduced sugar content and water control.
| Study group | Role | What they receive |
|---|---|---|
| Chocolate milk with a regular added sugar content | Experimental | Dairy product with a regular sugar content Receives: Other: Food |
| Chocolate milk with a reduced added sugar content | Experimental | Dairy product with a reduced sugar content Receives: Other: Food |
| Yogurt with a regular added sugar content | Experimental | Dairy product with a regular sugar content Receives: Other: Food |
| Yogurt with a reduced added sugar content | Experimental | Dairy product with a reduced sugar content Receives: Other: Food |
| Energy-free control | Experimental | Potable water 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 blood glucose
Measured: 0-120 minutes
Secondary outcomes (5)
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: 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 min) and a test meal (at 120 min) 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 posted22 Apr 2021
- Study start2 Sep 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Saint Vincent University
- Sponsor type
- University, hospital or other
- 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
- NCT04854603
- Sponsor's protocol ID
- 2019-202-01
- Status last verified
- Mar 2023
- First submitted
- 10 Apr 2021
- Last updated
- 16 Mar 2023
- 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 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dairy Products With Reduced Added Sugar Content on Blood Glucose, Satiety and Food Intake
- ClinicalTrials.gov ID
- NCT04854603
- Acronym / sponsor ID
- 2019-202-01
- Keywords
- Sugar intake, Sweeteners, Diabetes, Obesity, Sweetened food products, Chocolate milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mount Saint Vincent UniversityUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 22 Apr 2021 (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.
Dairy products represent an important food group in human nutrition as a source of calcium, protein, functional fats and low-glycaemic sugar lactose. While traditionally consumed natural milk and yogurt have low sugar content, many flavoured liquid dairy products such as chocolate milk, or fermented products such as yogurt have added sugar. Our recent studies have shown that the partial reduction of added sugar in chocolate milk and yogurt is not associated with any inferior sensory characteristics such as taste and pleasantness compared to their full-sugar counterparts. The current project will investigate whether the liquid dairy products with reduced sugar content (value-added products) have any benefits on blood glucose control in humans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Chocolate milk with a regular added sugar content | Experimental | Other: FoodDairy product with a regular sugar content |
| Chocolate milk with a reduced added sugar content | Experimental | Other: FoodDairy product with a reduced sugar content |
| Yogurt with a regular added sugar content | Experimental | Other: FoodDairy product with a regular sugar content |
| Yogurt with a reduced added sugar content | Experimental | Other: FoodDairy product with a reduced sugar content |
| Energy-free control | Experimental | Other: FoodPotable water |
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 regular and reduced sugar content and water control. | Other | Chocolate milk with a reduced added sugar content, Chocolate milk with a regular added sugar content, Energy-free control, Yogurt with a reduced added sugar content, Yogurt with a regular added sugar content |
Primary outcome
Blood glucose
Time frame: 0-120 minutes
The concentration of blood glucose
Insulin
Time frame: 0-120 minutes
The concentration of blood glucose
5 secondary outcomes
Satiety
Time frame: 0-120 minutes
Food intake
Time frame: 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 16 Mar 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 16 Mar 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 16 Mar 2023.